Published on: 2011-06-23
Hepatitis C virus (HCV) infection is a major worldwide problem causes acute and chronic HCV infection. Current treatment of HCV includes pegylated interferon-alpha (PEG IFN- alpha) plus ribavirin (RBV) which has significant side effects depending upon the type of genotype.
Currently, there is a need to develop antiviral agents, both from synthetic chemistry and Herbal sources. In the last decade, various novel HCV replication, helicase and entry inhibitors have been synthesized and some of which have been entered in different phases of clinical trials.
Successful results have been acquired by executing combinational therapy of compounds with standard regime in different HCV replicons. Even though, diverse groups of compounds have been described as antiviral targets against HCV via Specifically Targeted Antiviral Therapy for hepatitis C (STAT-C) approach (in which compounds are designed to directly block HCV or host proteins concerned in HCV replication), still there is a need to improve the properties of existing antiviral compounds.
In this review, we sum up potent antiviral compounds against entry, unwinding and replication of HCV and discussed their activity in combination with standard therapy. Conclusively, further innovative research on chemical compounds will lead to consistent standard therapy with fewer side effects.
Author: Sidra RehmanUsman AshfaqTariq Javed
Credits/Source: Genetic Vaccines and Therapy 2011, 9:11
Source
June 23, 2011
June 22, 2011
NAPWA's 17th Annual National HIV Testing Day, June 27th, Promotes Over 100 Activities Nationwide That Offer Free, Lifesaving, HIV Testing
June 21, 2011, 8:14 p.m. EDT
CDC Joins National Association of People With AIDS in Promoting Life Saving HIV Testing Initiatives
SILVER SPRING, MD, Jun 21, 2011 (MARKETWIRE via COMTEX) -- Tens of thousands of Americans are expected to be tested for HIV at events from coast to coast organized as part of the National Association of People with AIDS' (NAPWA) National HIV Testing Day (NHTD) on June 27th, 2011. A list of testing events nationwide is available at the Centers for Disease Control and Prevention website created to promote the events. Awareness is spreading online of events nationwide on Twitter, using #NHTD.
National HIV Testing Day is conducted by NAPWA in partnership with ACT Against AIDS, The Black AIDS Institute, Gilead, GetYourselfTested.org, GreaterThan.org, Health HIV, OraSure Technologies, Inc., and The Mayors Campaign Against HIV. The CDC provides a comprehensive list of testing locations open nationwide on National HIV Testing Day.
"This year, more than ever before, we know that HIV testing saves lives," said Frank Oldham, Jr., President and CEO of NAPWA. "Knowing your HIV status and seeking medical treatment in the event of a positive test not only extends survival for the person diagnosed, but it also helps stop the spread of the disease by empowering people living with HIV/AIDS to reduce transmission. This is why NAPWA founded National HIV Testing Day in 1995."
Mayors Campaign Against HIV Brings the Testing Message Home This year, NAPWA is also hosting the seventh annual Mayors Campaign Against HIV, in partnership with OraSure Technologies. Last year, more than 100 Mayors across the country supported National HIV Testing Day (NHTD) by hosting HIV testing campaigns in their cities, conducting news conferences to discuss local HIV testing resources, issuing proclamations in support of NHTD and even stepping forward and getting tested themselves.
NAPWA and OraSure partner with mayors and testing organizations throughout the United States to highlight the importance of routine HIV testing. NAPWA also collaborates with Congressional lawmakers to bring a renewed focus to testing and prevention initiatives.
"We are very pleased to be joining forces with NAPWA and participating mayors again this year as we publicly unite in the fight against HIV/AIDS through our Mayors Campaign Against HIV," said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies. "We are extremely proud that our technology is a driving force in getting more people tested and enabling HIV-positive individuals to learn their status earlier so they can access care sooner."
National NHTD Media Events For the fifth year in a row, NAPWA and U.S. Representative Barbara Lee (D-CA) will host a news conference (held June 24th -- call contact for details) on U.S. Capitol grounds to focus attention on the HIV epidemic and the need for those at risk for HIV to get tested. Other expected and invited speakers include Jeffrey Crowley, Director, White House Office of HIV/AIDS Policy and Mayor Vincent Gray, Washington, D.C.
"Up to 70 percent of new infections come from people who are unaware of their HIV status," said Representative Lee. "We must do everything we can to raise awareness in our communities about the benefits of testing whether on NAPWA's National HIV Testing Day, or any other day. Testing is a very important tool in the global response to this epidemic."
NAPWA will also join OraSure for a community observance of NHTD in New York City at the opening of the NASDAQ Stock Market on Monday, June 27, 2011.
A Shifting Legal Landscape: HIV Testing, Prevention, and Criminalization NAPWA recognizes early diagnosis and treatment of HIV infections as an important step towards reducing the number of new infections and controlling future public healthcare costs. The public interest in early detection and treatment is so compelling that legal and behavioral barriers to testing should be removed wherever they exist.
NAPWA therefore calls on states that do not offer anonymous HIV testing to do so, and for those that actually forbid it to change their laws. NAPWA also calls on states to repeal laws making certain behaviors illegal for people who know they have HIV but not for others. The laws do nothing to reduce the number of new infections. They do, however, give people who think they may be living with HIV but don't know for sure a powerful practical incentive not to get tested. By reducing the number of tests, the laws may actually increase the number of new infections.
HIV Testing Facts and Who Needs to Get Tested? Today, CDC estimates approximately 21 percent of the 1.1 million Americans living with HIV are unaware of their HIV status. These individuals unintentionally cause 54 to 70 percent of America's nearly 60,000 new infections annually. Seventy-five percent of HIV+ people will change risky behaviors when they learn their status. Risk-based testing is NOT reaching the goal of identifying all HIV+ people.
The CDC recommends testing for everyone ages 13 to 64. Everyone should be tested once and then decide how regularly to be tested. It's especially important for people in high-risk groups to get tested regularly. These include:
-- Sexually active younger teenagers;
-- Poor women of color;
-- Men who have sex with men (MSM);
-- People who inject or snort drugs with others;
-- Sex workers, including anyone who has to exchange sexual favors for necessities of life; and
-- People who live in HIV "hot spots," sometimes only a few blocks in area, where the HIV infection rate is so high that anyone who is sexually active is at risk.
About NAPWA's NHTD Take the Test, Take Control Campaign and Media Materials NAPWA believes voluntary HIV counseling and testing is a critical first step in taking control and responsibility over one's health, hence our message: "Take the Test, Take Control."
In partnership with the Greater Than AIDS Campaign and OraSure Technologies, NAPWA has distributed 70,000 NHTD posters to local health departments, community clinics and other community-based organizations that engage in HIV testing initiatives, to ensure that communities have the resources they need to mount an effective HIV testing campaign.
Electronic versions of the joint Greater Than AIDS Campaign (Get Yourself Tested) and the NAPWA's NHTD campaign (Take the Test, Take Control) can be found at www.greaterthan.org and NAPWA . Click here to read NAPWA's guidelines for routine testing and counseling.
The National Association of People with HIV/AIDS (NAPWA) is the largest and oldest advocacy group of and for people living with HIV/AIDS. The organization created AIDSWatch, the largest annual legislative briefing day by people living with HIV/AIDS, as well as National HIV Testing Day, June 27th, 2011. NAPWA's Healthy Living Summit in Dallas, August 7 to 10, 2011 is the preeminent educational forum for the daily health needs of people living with HIV/AIDS. More information is available at www.napwa.org . Follow us on Twitter @NAPWAUS.
CONTACT:
Peter Kronenberg
240 247-1025
Email Contact
SOURCE: National Association of People with AIDS
Source
CDC Joins National Association of People With AIDS in Promoting Life Saving HIV Testing Initiatives
SILVER SPRING, MD, Jun 21, 2011 (MARKETWIRE via COMTEX) -- Tens of thousands of Americans are expected to be tested for HIV at events from coast to coast organized as part of the National Association of People with AIDS' (NAPWA) National HIV Testing Day (NHTD) on June 27th, 2011. A list of testing events nationwide is available at the Centers for Disease Control and Prevention website created to promote the events. Awareness is spreading online of events nationwide on Twitter, using #NHTD.
National HIV Testing Day is conducted by NAPWA in partnership with ACT Against AIDS, The Black AIDS Institute, Gilead, GetYourselfTested.org, GreaterThan.org, Health HIV, OraSure Technologies, Inc., and The Mayors Campaign Against HIV. The CDC provides a comprehensive list of testing locations open nationwide on National HIV Testing Day.
"This year, more than ever before, we know that HIV testing saves lives," said Frank Oldham, Jr., President and CEO of NAPWA. "Knowing your HIV status and seeking medical treatment in the event of a positive test not only extends survival for the person diagnosed, but it also helps stop the spread of the disease by empowering people living with HIV/AIDS to reduce transmission. This is why NAPWA founded National HIV Testing Day in 1995."
Mayors Campaign Against HIV Brings the Testing Message Home This year, NAPWA is also hosting the seventh annual Mayors Campaign Against HIV, in partnership with OraSure Technologies. Last year, more than 100 Mayors across the country supported National HIV Testing Day (NHTD) by hosting HIV testing campaigns in their cities, conducting news conferences to discuss local HIV testing resources, issuing proclamations in support of NHTD and even stepping forward and getting tested themselves.
NAPWA and OraSure partner with mayors and testing organizations throughout the United States to highlight the importance of routine HIV testing. NAPWA also collaborates with Congressional lawmakers to bring a renewed focus to testing and prevention initiatives.
"We are very pleased to be joining forces with NAPWA and participating mayors again this year as we publicly unite in the fight against HIV/AIDS through our Mayors Campaign Against HIV," said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies. "We are extremely proud that our technology is a driving force in getting more people tested and enabling HIV-positive individuals to learn their status earlier so they can access care sooner."
National NHTD Media Events For the fifth year in a row, NAPWA and U.S. Representative Barbara Lee (D-CA) will host a news conference (held June 24th -- call contact for details) on U.S. Capitol grounds to focus attention on the HIV epidemic and the need for those at risk for HIV to get tested. Other expected and invited speakers include Jeffrey Crowley, Director, White House Office of HIV/AIDS Policy and Mayor Vincent Gray, Washington, D.C.
"Up to 70 percent of new infections come from people who are unaware of their HIV status," said Representative Lee. "We must do everything we can to raise awareness in our communities about the benefits of testing whether on NAPWA's National HIV Testing Day, or any other day. Testing is a very important tool in the global response to this epidemic."
NAPWA will also join OraSure for a community observance of NHTD in New York City at the opening of the NASDAQ Stock Market on Monday, June 27, 2011.
A Shifting Legal Landscape: HIV Testing, Prevention, and Criminalization NAPWA recognizes early diagnosis and treatment of HIV infections as an important step towards reducing the number of new infections and controlling future public healthcare costs. The public interest in early detection and treatment is so compelling that legal and behavioral barriers to testing should be removed wherever they exist.
NAPWA therefore calls on states that do not offer anonymous HIV testing to do so, and for those that actually forbid it to change their laws. NAPWA also calls on states to repeal laws making certain behaviors illegal for people who know they have HIV but not for others. The laws do nothing to reduce the number of new infections. They do, however, give people who think they may be living with HIV but don't know for sure a powerful practical incentive not to get tested. By reducing the number of tests, the laws may actually increase the number of new infections.
HIV Testing Facts and Who Needs to Get Tested? Today, CDC estimates approximately 21 percent of the 1.1 million Americans living with HIV are unaware of their HIV status. These individuals unintentionally cause 54 to 70 percent of America's nearly 60,000 new infections annually. Seventy-five percent of HIV+ people will change risky behaviors when they learn their status. Risk-based testing is NOT reaching the goal of identifying all HIV+ people.
The CDC recommends testing for everyone ages 13 to 64. Everyone should be tested once and then decide how regularly to be tested. It's especially important for people in high-risk groups to get tested regularly. These include:
-- Sexually active younger teenagers;
-- Poor women of color;
-- Men who have sex with men (MSM);
-- People who inject or snort drugs with others;
-- Sex workers, including anyone who has to exchange sexual favors for necessities of life; and
-- People who live in HIV "hot spots," sometimes only a few blocks in area, where the HIV infection rate is so high that anyone who is sexually active is at risk.
About NAPWA's NHTD Take the Test, Take Control Campaign and Media Materials NAPWA believes voluntary HIV counseling and testing is a critical first step in taking control and responsibility over one's health, hence our message: "Take the Test, Take Control."
In partnership with the Greater Than AIDS Campaign and OraSure Technologies, NAPWA has distributed 70,000 NHTD posters to local health departments, community clinics and other community-based organizations that engage in HIV testing initiatives, to ensure that communities have the resources they need to mount an effective HIV testing campaign.
Electronic versions of the joint Greater Than AIDS Campaign (Get Yourself Tested) and the NAPWA's NHTD campaign (Take the Test, Take Control) can be found at www.greaterthan.org and NAPWA . Click here to read NAPWA's guidelines for routine testing and counseling.
The National Association of People with HIV/AIDS (NAPWA) is the largest and oldest advocacy group of and for people living with HIV/AIDS. The organization created AIDSWatch, the largest annual legislative briefing day by people living with HIV/AIDS, as well as National HIV Testing Day, June 27th, 2011. NAPWA's Healthy Living Summit in Dallas, August 7 to 10, 2011 is the preeminent educational forum for the daily health needs of people living with HIV/AIDS. More information is available at www.napwa.org . Follow us on Twitter @NAPWAUS.
CONTACT:
Peter Kronenberg
240 247-1025
Email Contact
SOURCE: National Association of People with AIDS
Source
Popular Nonprofit Organization Falls Victim to Economic Downturn
North Miami, FL, June 22, 2011 --(PR.com)-- ALERT Health, a nonprofit organization providing preventive health counseling, testing, and referral will close its office on June 30th due to funding constraints.
Founded in 1997 as “Hep-C ALERT” by Andi Thomas, a patient affected by chronic Hepatitis C, its original mission was to raise awareness and assist people affected by this insidious disease. Upon moving the organization to downtown North Miami in 2001, Thomas began offering screenings for other diseases, including HIV, sexually transmitted infection, Hepatitis B, blood pressure, and cholesterol. Her vision of providing several clinical screenings in a single visit, in a welcoming setting, and at no cost removed major barriers to preventive care and led the agency to a new name and updated mission in 2007.
Thomas’ approach proved popular with local residents, particularly uninsured young adults. Jess Bardisa, Development Director, said, “We experienced a 900% increase in client visits between 2004 and 2008 – from seeing 60 people per month to more than 600.” Bardisa explained that more than half of clients seen each month were new to the organization and nearly all were referred by other clients. “Our service philosophy created this great word-of-mouth referral network. We didn’t even advertise.” The organization has served over 33,000 people since 1997.
Thomas said, "The economic downturn and shifting public health priorities has taken its toll on our funding. I’ve done everything in my power to keep the agency running after several critical grants failed to come through in early 2009.” As one of a handful of expert Hepatitis C organizations in the country, and the only full-time HIV testing site serving the northeast sector of Miami-Dade, thousands of people will be left without a place to go. She continued, “I am deeply concerned about the void that will be left once ALERT Health closes its doors.”
“There are no other organizations in North Miami that can step in and handle the 300 plus clients we see each month, and none locally that offer support for people with Hepatitis C,” said Jon Kelly, the organization’s Project Coordinator. Thomas emphasized that “ALERT Health’s exit couldn’t come at a worse time. We just celebrated the approval of a new class of Hepatitis C drugs last month; the first major treatment breakthrough in a decade.” ALERT Health is working with local health departments to identify other organizations to refer clients to.
ALERT Health, Inc. mission is to improve health and quality of life for people affected by chronic disease, by providing accessible, integrated, preventive care. For more information, please visit http://www.alerthealth.org/.
###
Contact Information
ALERT Health, Inc.
Andi Thomas or Jess Bardisa
305-893-7992 x101 or x103
info@alerthealth.org
http://www.alerthealth.org/
Source
Founded in 1997 as “Hep-C ALERT” by Andi Thomas, a patient affected by chronic Hepatitis C, its original mission was to raise awareness and assist people affected by this insidious disease. Upon moving the organization to downtown North Miami in 2001, Thomas began offering screenings for other diseases, including HIV, sexually transmitted infection, Hepatitis B, blood pressure, and cholesterol. Her vision of providing several clinical screenings in a single visit, in a welcoming setting, and at no cost removed major barriers to preventive care and led the agency to a new name and updated mission in 2007.
Thomas’ approach proved popular with local residents, particularly uninsured young adults. Jess Bardisa, Development Director, said, “We experienced a 900% increase in client visits between 2004 and 2008 – from seeing 60 people per month to more than 600.” Bardisa explained that more than half of clients seen each month were new to the organization and nearly all were referred by other clients. “Our service philosophy created this great word-of-mouth referral network. We didn’t even advertise.” The organization has served over 33,000 people since 1997.
Thomas said, "The economic downturn and shifting public health priorities has taken its toll on our funding. I’ve done everything in my power to keep the agency running after several critical grants failed to come through in early 2009.” As one of a handful of expert Hepatitis C organizations in the country, and the only full-time HIV testing site serving the northeast sector of Miami-Dade, thousands of people will be left without a place to go. She continued, “I am deeply concerned about the void that will be left once ALERT Health closes its doors.”
“There are no other organizations in North Miami that can step in and handle the 300 plus clients we see each month, and none locally that offer support for people with Hepatitis C,” said Jon Kelly, the organization’s Project Coordinator. Thomas emphasized that “ALERT Health’s exit couldn’t come at a worse time. We just celebrated the approval of a new class of Hepatitis C drugs last month; the first major treatment breakthrough in a decade.” ALERT Health is working with local health departments to identify other organizations to refer clients to.
ALERT Health, Inc. mission is to improve health and quality of life for people affected by chronic disease, by providing accessible, integrated, preventive care. For more information, please visit http://www.alerthealth.org/.
###
Contact Information
ALERT Health, Inc.
Andi Thomas or Jess Bardisa
305-893-7992 x101 or x103
info@alerthealth.org
http://www.alerthealth.org/
Source
Pharmasset Announces Issuance of U.S. Patent for PSI-7977
-- USPTO grants patent covering the anti-HCV drug PSI-7977
PRINCETON, N.J., June 22, 2011 /PRNewswire/ -- Pharmasset, Inc. (Nasdaq: VRUS) announces that the United States Patent and Trademark Office has issued U.S. patent 7,964,580 ("the '580 patent") titled "Nucleoside Phosphoramidate Prodrugs". This patent generally relates to the composition of matter of PSI-7977 and its diastereomeric mixture for the treatment of hepatitis C virus (HCV). PSI-7977, a uracil nucleotide analogue polymerase inhibitor of HCV, is being studied in multiple phase 2 trials.
"Today's announcement is a credit to our in-house research team in discovering new HCV product candidates," stated Schaefer Price, Pharmasset's President and Chief Executive Officer. "As the '580 patent is not due to expire until 2029, not including any patent term extension, it should become an important part of a growing portfolio of issued patents covering PSI-7977."
About PSI-7977
PSI-7977, one of two diastereomers comprising PSI-7851, is a prodrug of a uracil nucleotide analog polymerase inhibitor we are developing for the treatment of chronic HCV infection. PSI-7977 has completed a 28 day phase 2a trial in combination with peg-interferon and ribavirin (Peg-IFN/RBV) and is currently being tested in four phase 2b studies: the PROTON trial in combination with peg-IFN/RBV in HCV genotype 1, 2 or 3 patients; the ATOMIC trial with peg-IFN/RBV in HCV genotypes 1,4,5,6; the ELECTRON trial, an interferon sparing /interferon free study in HCV genotypes 1,2 and 3 and a study with Bristol-Myers Squibb's NS5a inhibitor, BMS-790052, as part of an interferon free regimen. Pharmasset also anticipates initiating its own interferon free trial with PSI-7977 and PSI-938, a guanine nucleotide polymerase inhibitor in the third calendar quarter 2011.
About Pharmasset
Pharmasset is a clinical-stage pharmaceutical company committed to discovering, developing, and commercializing novel drugs to treat viral infections. Pharmasset's primary focus is the development of oral therapeutics for the treatment of hepatitis C virus (HCV) infection. Our research and development efforts are focused on nucleoside/tide analogs, a class of compounds which act as alternative substrates for the viral polymerase, thus inhibiting viral replication. We currently have three clinical-stage product candidates advancing in trials in various populations. Our pyrimidine, PSI-7977, an unpartnered uracil nucleotide analog, is currently under study in four Phase 2b trials in patients with HCV genotypes 1 through 6, including abbreviated duration interferon and interferon-free regimens. Our purine, PSI-938, an unpartnered guanosine nucleotide analog, recently reported safety and efficacy data from 14 days of monotherapy as well as 14 days in combination with the pyrimidine, PSI-7977. An SVR-endpoint study of the purine-pyrimidine combination is anticipated to begin in the third quarter of 2011. Mericitabine (RG7128) continues in two Phase 2b trials and one interferon-free trial being conducted through a strategic collaboration with Roche.
Pharmasset Forward-Looking Statements
Pharmasset "Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release that are not historical facts are "forward-looking statements," that involve risks, uncertainties, and other important factors, including, without limitation, the risk of cessation or delay of any of the ongoing or planned clinical trials and/or our development of our product candidates, the risk that the results of previously conducted studies involving our product candidates will not be repeated or observed in ongoing or future studies involving our product candidates, the risk that our collaboration with Roche will not continue or will not be successful, and the risk that any one or more of our product candidates will not be successfully developed and commercialized. For a discussion of risks, uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in our Annual Report on Form 10-K for the fiscal year ended September 30, 2010 and our Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission and discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission.
CONTACT: Richard Smith, +1-609-865-0693, rsmith@pharmasset.com
SOURCE Pharmasset, Inc.
RELATED LINKS
http://www.pharmasset.com/
Source
PRINCETON, N.J., June 22, 2011 /PRNewswire/ -- Pharmasset, Inc. (Nasdaq: VRUS) announces that the United States Patent and Trademark Office has issued U.S. patent 7,964,580 ("the '580 patent") titled "Nucleoside Phosphoramidate Prodrugs". This patent generally relates to the composition of matter of PSI-7977 and its diastereomeric mixture for the treatment of hepatitis C virus (HCV). PSI-7977, a uracil nucleotide analogue polymerase inhibitor of HCV, is being studied in multiple phase 2 trials.
"Today's announcement is a credit to our in-house research team in discovering new HCV product candidates," stated Schaefer Price, Pharmasset's President and Chief Executive Officer. "As the '580 patent is not due to expire until 2029, not including any patent term extension, it should become an important part of a growing portfolio of issued patents covering PSI-7977."
About PSI-7977
PSI-7977, one of two diastereomers comprising PSI-7851, is a prodrug of a uracil nucleotide analog polymerase inhibitor we are developing for the treatment of chronic HCV infection. PSI-7977 has completed a 28 day phase 2a trial in combination with peg-interferon and ribavirin (Peg-IFN/RBV) and is currently being tested in four phase 2b studies: the PROTON trial in combination with peg-IFN/RBV in HCV genotype 1, 2 or 3 patients; the ATOMIC trial with peg-IFN/RBV in HCV genotypes 1,4,5,6; the ELECTRON trial, an interferon sparing /interferon free study in HCV genotypes 1,2 and 3 and a study with Bristol-Myers Squibb's NS5a inhibitor, BMS-790052, as part of an interferon free regimen. Pharmasset also anticipates initiating its own interferon free trial with PSI-7977 and PSI-938, a guanine nucleotide polymerase inhibitor in the third calendar quarter 2011.
About Pharmasset
Pharmasset is a clinical-stage pharmaceutical company committed to discovering, developing, and commercializing novel drugs to treat viral infections. Pharmasset's primary focus is the development of oral therapeutics for the treatment of hepatitis C virus (HCV) infection. Our research and development efforts are focused on nucleoside/tide analogs, a class of compounds which act as alternative substrates for the viral polymerase, thus inhibiting viral replication. We currently have three clinical-stage product candidates advancing in trials in various populations. Our pyrimidine, PSI-7977, an unpartnered uracil nucleotide analog, is currently under study in four Phase 2b trials in patients with HCV genotypes 1 through 6, including abbreviated duration interferon and interferon-free regimens. Our purine, PSI-938, an unpartnered guanosine nucleotide analog, recently reported safety and efficacy data from 14 days of monotherapy as well as 14 days in combination with the pyrimidine, PSI-7977. An SVR-endpoint study of the purine-pyrimidine combination is anticipated to begin in the third quarter of 2011. Mericitabine (RG7128) continues in two Phase 2b trials and one interferon-free trial being conducted through a strategic collaboration with Roche.
Pharmasset Forward-Looking Statements
Pharmasset "Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release that are not historical facts are "forward-looking statements," that involve risks, uncertainties, and other important factors, including, without limitation, the risk of cessation or delay of any of the ongoing or planned clinical trials and/or our development of our product candidates, the risk that the results of previously conducted studies involving our product candidates will not be repeated or observed in ongoing or future studies involving our product candidates, the risk that our collaboration with Roche will not continue or will not be successful, and the risk that any one or more of our product candidates will not be successfully developed and commercialized. For a discussion of risks, uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in our Annual Report on Form 10-K for the fiscal year ended September 30, 2010 and our Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission and discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission.
CONTACT: Richard Smith, +1-609-865-0693, rsmith@pharmasset.com
SOURCE Pharmasset, Inc.
RELATED LINKS
http://www.pharmasset.com/
Source
Study reveals possible association between HCV, HBV, P. falciparum infections
Posted June 22, 2011
Ouwe-Missi-Oukem-Boyer O. PLoS ONE. 2011;doi:10.1371/journal.pone.0016034.
New findings suggest a possible epidemiological interaction between hepatitis C, hepatitis B and Plasmodium falciparum infections. Age was a key factor in this association and hepatitis C virus led to slower emergence of P. falciparum in the blood, according to Odile Ouwe-Missi-Oukem-Boyer, PhD, and colleagues.
In the pilot study, researchers assigned 319 participants, aged between 13 and 85 residing in Dienga, Africa, to a curative antimalarial treatment. Microscopy and polymerase chain reaction (PCR) were used to monitor the emergence of P. falciparum in participant’s blood every 2 weeks for 1 year duration.
Sixty-five participants tested positive for malaria parasites; 61 were HCV carriers; 36 were HBV carriers; and P. falciparum was detected in 203 patients at 1 year follow-up. Of those with P. falciparum, 25 were HBV carriers and 28 were HCV carriers. Most HBV carriers were younger than 30 years; the likelihood of HCV infection increased significantly with age.
Median time to P. falciparum emergence in blood was 140 days and 120 days in HBV-negative and positive participants, and 135 days and 224 days in HCV-negative and positive participants, respectively. Compared with those without HCV infection, HCV carriage was associated with a slower emergence of P. falciparum infection in the blood.
“HCV carrier status but not HBV carrier status was significantly associated with slower emergence of malaria parasites in univariate analysis, along with older age and self-medication,” the researchers wrote. “The relation with HCV carrier status was confirmed in multivariate analysis, although the P value was just above the threshold of significance. As age is a confounding factor, the influence of HCV infection on the natural course of P. falciparummalaria would be best examined in a case-control study.”
Disclosure: The researchers report no relevant financial disclosures.
Source
Ouwe-Missi-Oukem-Boyer O. PLoS ONE. 2011;doi:10.1371/journal.pone.0016034.
New findings suggest a possible epidemiological interaction between hepatitis C, hepatitis B and Plasmodium falciparum infections. Age was a key factor in this association and hepatitis C virus led to slower emergence of P. falciparum in the blood, according to Odile Ouwe-Missi-Oukem-Boyer, PhD, and colleagues.
In the pilot study, researchers assigned 319 participants, aged between 13 and 85 residing in Dienga, Africa, to a curative antimalarial treatment. Microscopy and polymerase chain reaction (PCR) were used to monitor the emergence of P. falciparum in participant’s blood every 2 weeks for 1 year duration.
Sixty-five participants tested positive for malaria parasites; 61 were HCV carriers; 36 were HBV carriers; and P. falciparum was detected in 203 patients at 1 year follow-up. Of those with P. falciparum, 25 were HBV carriers and 28 were HCV carriers. Most HBV carriers were younger than 30 years; the likelihood of HCV infection increased significantly with age.
Median time to P. falciparum emergence in blood was 140 days and 120 days in HBV-negative and positive participants, and 135 days and 224 days in HCV-negative and positive participants, respectively. Compared with those without HCV infection, HCV carriage was associated with a slower emergence of P. falciparum infection in the blood.
“HCV carrier status but not HBV carrier status was significantly associated with slower emergence of malaria parasites in univariate analysis, along with older age and self-medication,” the researchers wrote. “The relation with HCV carrier status was confirmed in multivariate analysis, although the P value was just above the threshold of significance. As age is a confounding factor, the influence of HCV infection on the natural course of P. falciparummalaria would be best examined in a case-control study.”
Disclosure: The researchers report no relevant financial disclosures.
Source
Gold nanoparticles help earlier diagnosis of liver cancer
Public release date: 22-Jun-2011
Contact: Richard Lewis
Richard_Lewis@brown.edu
401-863-3766
Brown University
PROVIDENCE, R.I. [Brown University] — Hepatocellular carcinoma is the most common cancer to strike the liver. More than 500,000 people worldwide, concentrated in sub-Saharan Africa and Southeast Asia, are diagnosed with it yearly. Most of those afflicted die within six months.
A big obstacle to treatment of liver cancer is the lack of early diagnosis. Current techniques, including ultrasound, CT and MRI scans, spot tumors only when they have grown to about 5 centimeters in diameter. By that time, the cancer is especially aggressive, resisting chemotherapy and difficult to remove surgically.
Now a research team led by Brown University reports some promising results for earlier diagnosis. In lab tests, the team used gold nanoparticles ringed by a charged polymer coating and an X-ray scatter imaging technique to spot tumor-like masses as small as 5 millimeters. The approach, detailed in the American Chemical Society journal Nano Letters, marks the first time that metal nanoparticles have been used as agents to enhance X-ray scattering signals to image tumor-like masses.
"What we're doing is not a screening method," said Christoph Rose-Petruck, professor of chemistry at Brown University and corresponding author on the paper. "But in a routine exam, with people who have risk factors, such as certain types of hepatitis, we can use this technique to see a tumor that is just a few millimeters in diameter, which, in terms of size, is a factor of 10 smaller."
The team took gold nanoparticles of 10 and 50 nanometers in diameter and ringed them with a pair of 1-nanometer polyelectrolyte coatings. The coating gave the nanoparticles a charge, which increased the chances that they would be engulfed by the cancerous cells. Once engulfed, the team used X-ray scatter imaging to detect the gold nanoparticles within the malignant cells. In lab tests, the nontoxic gold nanoparticles made up just 0.0006 percent of the cell's volume, yet the nanoparticles had enough critical mass to be detected by the X-ray scatter imaging device.
"We have shown that even with these small numbers, we can distinguish these [tumor] cells," Rose-Petruck said.
The next step for the researchers is on the clinical side. Beginning this summer, the group will attach a cancer-targeting antibody to the nanoparticle vehicle to search for liver tumors in mice. The antibody that will be used was developed by Jack Wands, director of the Liver Research Center at Rhode Island Hospital and professor of medical science at the Warren Alpert Medical School of Brown University.
"We have developed a monoclonal antibody that targets a cell surface protein highly expressed on liver cancer cells," Wands said. "We plan to couple the antibody to the gold nanoparticles in an attempt to detect the growth of early tumors in the liver by X-ray imaging."
The researchers say the X-ray scatter imaging method could be used to detect nanoparticle assemblies in other organs. "The idea should be that if you can figure out to get that [nanoparticle] to specific sites in the body, you can figure out how to image it," said Danielle Rand, a second-year graduate student in chemistry and the first author on the paper.
###
Contributing authors include Yanan Liu from Brown, Wands, Zoltan Derdak and Vivian Ortiz from the Liver Research Center, and Milan Taticek at the Czech Technical University in Prague.
The National Institutes of Health and the U.S. Department of Energy funded the research. Rand's work was supported by the U.S. Department of Education through the Graduate Assistance in Areas of National Need (GAANN) fellowship, administered by the Institute for Molecular and Nanoscale Innovation at Brown.
Source
Contact: Richard Lewis
Richard_Lewis@brown.edu
401-863-3766
Brown University
PROVIDENCE, R.I. [Brown University] — Hepatocellular carcinoma is the most common cancer to strike the liver. More than 500,000 people worldwide, concentrated in sub-Saharan Africa and Southeast Asia, are diagnosed with it yearly. Most of those afflicted die within six months.
A big obstacle to treatment of liver cancer is the lack of early diagnosis. Current techniques, including ultrasound, CT and MRI scans, spot tumors only when they have grown to about 5 centimeters in diameter. By that time, the cancer is especially aggressive, resisting chemotherapy and difficult to remove surgically.
Now a research team led by Brown University reports some promising results for earlier diagnosis. In lab tests, the team used gold nanoparticles ringed by a charged polymer coating and an X-ray scatter imaging technique to spot tumor-like masses as small as 5 millimeters. The approach, detailed in the American Chemical Society journal Nano Letters, marks the first time that metal nanoparticles have been used as agents to enhance X-ray scattering signals to image tumor-like masses.
"What we're doing is not a screening method," said Christoph Rose-Petruck, professor of chemistry at Brown University and corresponding author on the paper. "But in a routine exam, with people who have risk factors, such as certain types of hepatitis, we can use this technique to see a tumor that is just a few millimeters in diameter, which, in terms of size, is a factor of 10 smaller."
The team took gold nanoparticles of 10 and 50 nanometers in diameter and ringed them with a pair of 1-nanometer polyelectrolyte coatings. The coating gave the nanoparticles a charge, which increased the chances that they would be engulfed by the cancerous cells. Once engulfed, the team used X-ray scatter imaging to detect the gold nanoparticles within the malignant cells. In lab tests, the nontoxic gold nanoparticles made up just 0.0006 percent of the cell's volume, yet the nanoparticles had enough critical mass to be detected by the X-ray scatter imaging device.
"We have shown that even with these small numbers, we can distinguish these [tumor] cells," Rose-Petruck said.
The next step for the researchers is on the clinical side. Beginning this summer, the group will attach a cancer-targeting antibody to the nanoparticle vehicle to search for liver tumors in mice. The antibody that will be used was developed by Jack Wands, director of the Liver Research Center at Rhode Island Hospital and professor of medical science at the Warren Alpert Medical School of Brown University.
"We have developed a monoclonal antibody that targets a cell surface protein highly expressed on liver cancer cells," Wands said. "We plan to couple the antibody to the gold nanoparticles in an attempt to detect the growth of early tumors in the liver by X-ray imaging."
The researchers say the X-ray scatter imaging method could be used to detect nanoparticle assemblies in other organs. "The idea should be that if you can figure out to get that [nanoparticle] to specific sites in the body, you can figure out how to image it," said Danielle Rand, a second-year graduate student in chemistry and the first author on the paper.
###
Contributing authors include Yanan Liu from Brown, Wands, Zoltan Derdak and Vivian Ortiz from the Liver Research Center, and Milan Taticek at the Czech Technical University in Prague.
The National Institutes of Health and the U.S. Department of Energy funded the research. Rand's work was supported by the U.S. Department of Education through the Graduate Assistance in Areas of National Need (GAANN) fellowship, administered by the Institute for Molecular and Nanoscale Innovation at Brown.
Source
New England Journal of Medicine Publishes Data From Two Phase 3 Studies of INCIVEK™ (telaprevir) in Hepatitis C
June 22, 2011
-INCIVEK was recently approved by the FDA and is now available for people with the most common form of chronic hepatitis C who are new to treatment and those who were treated before but not cured-
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the New England Journal of Medicine (NEJM) published data from two Phase 3 studies of INCIVEK™ (telaprevir) tablets, which showed that INCIVEK (in-SEE-veck) combination therapy significantly improved rates of sustained viral response (SVR, or viral cure) in a broad group of people with genotype 1 chronic hepatitis C who were new to treatment and those who were treated previously but not cured (relapsers, partial responders and null responders). Data from these studies, which included nearly 2,000 people, are published in the June 23, 2011 issue of NEJM.
In the ADVANCE study, INCIVEK combination therapy significantly improved viral cure rates in people who were new to treatment compared to those who received pegylated-interferon and ribavirin alone, two other medicines approved for hepatitis C. The majority of people who received INCIVEK combination therapy in this study were able to complete treatment in 24 weeks — half the time needed if they were to have taken pegylated-interferon and ribavirin alone. In the REALIZE study, which included people who were treated previously but not cured, viral cure rates were three-to-six-times higher with INCIVEK combination therapy compared to treatment with pegylated-interferon and ribavirin alone. Rash and anemia were the most common side effects reported with INCIVEK, which led to treatment discontinuation in about 1 percent of people in clinical studies.
"In the ADVANCE study, 79 percent of people with hepatitis C who had not been treated previously achieved a viral cure with INCIVEK combination therapy and the majority were able to cut treatment time in half," said Ira Jacobson, M.D., Chief of the Division of Gastroenterology and Hepatology, Weill Cornell Medical College, lead author and principal investigator for the ADVANCE study. "The results from this landmark study represent a paradigm shift in the treatment of hepatitis C and give us a new reason to encourage people to get tested and treated to potentially avoid the life-threatening consequences that can be associated with the disease."
"Many people with chronic hepatitis C who were treated previously but not cured have been waiting for new medicines, like INCIVEK, that offer a better chance to clear the virus," said Stefan Zeuzem, M.D., Professor of Medicine and Chief of the Department of Medicine at the JW Goethe University Hospital, Frankfurt, Germany, lead author and principal investigator for the REALIZE study. "In the REALIZE study, 86 percent of people who relapsed after being treated previously achieved a viral cure with INCIVEK combination therapy."
"The publication of these groundbreaking data follows the recent approval of INCIVEK, and it's exciting to know that some people are now completing their first month of INCIVEK combination treatment," said Peter Mueller, Ph.D., Chief Scientific Officer and Executive Vice President of Global Research and Development at Vertex.
On May 23, 2011, the U.S. Food and Drug Administration (FDA) approved INCIVEK for the treatment of genotype 1 chronic hepatitis C in adults with compensated liver disease (some level of damage to the liver but the liver still functions), including cirrhosis (scarring of the liver). The approval was based on data from three Phase 3 studies, including ADVANCE and REALIZE. The SVR (viral cure) rates included below are based on the approved analysis conducted by the FDA and Vertex and can be found in the Prescribing Information for INCIVEK.
People who received INCIVEK combination treatment achieved significantly higher rates of SVR, or viral cure, compared to those who received pegylated-interferon and ribavirin alone, regardless of prior treatment experience:
ADVANCE:
-- People new to treatment: 79 percent vs. 46 percent
REALIZE:
-- Relapsers: 86 percent vs. 22 percent
-- Partial responders: 59 percent vs. 15 percent
-- Null responders: 32 percent vs. 5 percent
INCIVEK was studied in all three groups of people who were treated previously but not cured. These groups included:
• Relapsers: defined as people whose hepatitis C virus was undetectable after a full course of previous treatment, but whose virus became detectable during the follow-up period;
• Partial responders: defined as people who achieved at least a 2 log10 reduction in hepatitis C virus at week 12, but whose hepatitis C virus never became undetectable by week 24 of a prior course of therapy; and
• Null responders: defined as people who achieved a less than 2 log10 reduction in hepatitis C virus at week 12 of a prior course of therapy. INCIVEK is the only newly approved medicine that has been studied in null responders.
Rash and anemia are the most serious side effects associated with INCIVEK. The most common side effects reported with INCIVEK combination treatment include fatigue, itching, nausea, diarrhea, vomiting, anal or rectal problems and taste changes.
For more information on INCIVEK, including full Prescribing Information, please visit http://www.incivek.com/.
About the ADVANCE and REALIZE Studies
ADVANCE and REALIZE were pivotal, Phase 3 randomized, double-blind, placebo-controlled, global studies, which evaluated INCIVEK in combination with Pegasys® (pegylated-interferon alfa-2a) and Copegus® (ribavirin). Both of these studies were part of a nearly 4,000-person clinical development program for INCIVEK. ADVANCE included 1,088 people who were new to treatment. REALIZE included 662 people who were treated previously but not cured, including relapsers, partial responders and null responders. The primary endpoint of these studies was SVR, or viral cure, in people who received INCIVEK combination therapy compared to those who received treatment with pegylated-interferon and ribavirin alone.
About INCIVEK
INCIVEK is an oral medicine that acts directly on the hepatitis C virus protease, an enzyme essential for viral replication. INCIVEK (750 mg) is given as two 375-mg tablets three-times daily for 12 weeks in combination with pegylated-interferon and ribavirin. Each monthly package of INCIVEK contains four weekly boxes that include daily blister strips to help patients keep track of their doses. After the first 12 weeks, all patients stop receiving INCIVEK and continue treatment with pegylated-interferon and ribavirin alone for an additional 12 weeks or 36 weeks of treatment. With INCIVEK combination therapy, more than 60 percent of people treated for the first time, as well as those who relapsed after previous therapy, are expected to complete all treatment in 24 weeks. All other patients receive a total of 48 weeks of treatment.
Vertex developed telaprevir in collaboration with Tibotec BVBA and Mitsubishi Tanabe Pharma. Vertex has rights to commercialize telaprevir in North America. Telaprevir was approved by the FDA in May 2011 and will be marketed in the United States under the brand name INCIVEK (in-SEE-veck). In Canada, telaprevir is under Priority Review by the Therapeutic Product Directorate (TPD) of Health Canada. Through its affiliate, Janssen, Tibotec has rights to commercialize telaprevir in Europe, South America, Australia, the Middle East and certain other countries. In December 2010, Janssen announced that the European Medicines Agency (EMA) accepted telaprevir for Accelerated Assessment in Europe. Mitsubishi Tanabe Pharma has rights to commercialize telaprevir in Japan and certain Far East countries.
Indication
INCIVEK™ (telaprevir) tablets is a prescription medicine used with the medicines peginterferon alfa and ribavirin to treat chronic (lasting a long time) hepatitis C genotype 1 infection in adults with stable liver problems, who have not been treated before or who have failed previous treatment.
It is not known if INCIVEK is safe and effective in children under 18 years of age.
IMPORTANT SAFETY INFORMATION
INCIVEK should always be taken in combination with peginterferon alfa and ribavirin. Ribavirin may cause birth defects or death of an unborn baby. Therefore, you should not take INCIVEK combination treatment if you are pregnant or may become pregnant, or if you are a man with a sexual partner who is pregnant.
INCIVEK and other medicines can affect each other and can also cause side effects that can be serious or life threatening. There are certain medicines you cannot take with INCIVEK combination treatment. Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements.
INCIVEK can cause serious side effects including rash and anemia. The most common side effects of INCIVEK include itching, nausea, diarrhea, vomiting, anal or rectal problems, taste changes and tiredness. There are other possible side effects of INCIVEK, and side effects associated with peginterferon alfa and ribavirin also apply to INCIVEK combination treatment. Tell your healthcare provider about any side effect that bothers you or doesn't go away.
Please see full Prescribing Information for INCIVEK, including the Medication Guide, available at http://www.incivek.com/.
You are encouraged to report negative side effects of prescription drugs to the FDA at 1-800-FDA-1088 OR 1-800-332-1088 or www.fda.gov/medwatch. You may also report side effects to Vertex at 1-877-824-4281 .
INCIVEK™ is a trademark of Vertex Pharmaceuticals Incorporated.
PEGASYS® and COPEGUS® are registered trademarks of Hoffmann-La Roche.
About Hepatitis C
Hepatitis C is a serious liver disease caused by the hepatitis C virus, which is spread through direct contact with the blood of infected people and ultimately affects the liver.1 Chronic hepatitis C can lead to serious and life-threatening liver problems, including liver damage, cirrhosis, liver failure or liver cancer.1 Though many people with hepatitis C may not experience symptoms, others may have symptoms such as fatigue, fever, jaundice and abdominal pain.1
Unlike HIV and hepatitis B virus, chronic hepatitis C is curable.2 However, approximately 60 percent of people do not achieve SVR,3,4,5 or viral cure,6 after treatment with 48 weeks of pegylated-interferon and ribavirin alone. If treatment is not successful and a person does not achieve a viral cure, they remain at an increased risk for progressive liver disease.7,8
More than 170 million people worldwide are chronically infected with hepatitis C.6 In the United States, nearly 4 million people have chronic hepatitis C and 75 percent of them are unaware of their infection.9 Hepatitis C is four times more prevalent in the United States compared to HIV.9 The majority of people with hepatitis C in the United States were born between 1946 and 1964, accounting for two of every three people with chronic hepatitis C.10 Hepatitis C is the leading cause of liver transplantations in the United States and is reported to contribute to 4,600 to 12,000 deaths annually.11,12 By 2029, total annual medical costs in the United States for people with hepatitis C are expected to more than double, from $30 billion in 2009 to approximately $85 billion.9
About Vertex
Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives. Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, epilepsy and other life-threatening diseases.
Founded more than 20 years ago in Cambridge, MA, we now have ongoing worldwide research programs and sites in the U.S., U.K. and Canada.
(VRTX - GEN)
1 Centers for Disease Control and Prevention. Hepatitis C Fact Sheet: CDC Viral Hepatitis. Available at: http://www.cdc.gov/hepatitis/HCV/PDFs/HepCGeneralFactSheet.pdf. Accessed March 21, 2011.
2 Pearlman BL and Traub N. Sustained Virologic Response to Antiviral Therapy for Chronic Hepatitis C Virus Infection: A Cure and So Much More. Clin Infect Dis. 2011 Apr;52(7):889-900.
3 Manns MP, McHutchison JG, Gordon SC, et al. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet. 2001;358:958-965.
4 Fried MW, Shiffman ML, Reddy KR, et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med. 2002;347:975-982.
5 McHutchison JG, Lawitz EJ, Shiffman ML, et al; IDEAL Study Team. Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection. N Engl J Med. 2009;361:580-593.
6 Ghany MG, Strader DB, Thomas DL, Seeff, LB. Diagnosis, management and treatment of hepatitis C; An update. Hepatology. 2009;49 (4):1-40.
7 Morgan TR, Ghany MG, Kim HY, Snow KK, Lindsay K, Lok AS. Outcome of sustained virological responders and non-responders in the Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis (HALT-C) trial. Hepatology. 2008;50(Suppl 4):357A (Abstract 115).
8 Veldt BJ, Heathcote J, Wedmeyer H. Sustained virologic response and clinical outcomes in patients with chronic hepatitis C and advanced fibrosis. Annals of Internal Medicine. 2007; 147: 677-684.
9 Institute of Medicine of the National Academies. Hepatitis and liver cancer: a national strategy for prevention and control of hepatitis B and C. Colvin HM and Mitchell AE, ed. Available at: http://www.iom.edu/Reports/2010/Hepatitis-and-Liver-Cancer-A-National-Strategy-for-Prevention-and-Control-of-Hepatitis-B-and-C.aspx. Updated January 11, 2010. Accessed March 21, 2011.
10 Pyenson B, Fitch K, Iwasaki K. Consequences of hepatitis C virus (HCV): Costs of a baby boomer epidemic of liver disease. Available at: http://www.natap.org/2009/HCV/051809_01.htm. Updated May 2009. Accessed March 21, 2011. This report was commissioned by Vertex Pharmaceuticals, Inc.
11 Volk MI, Tocco R, Saini S, Lok, ASF. Public health impact of antiviral therapy for hepatitis C in the United States. Hepatology. 2009;50(6):1750-1755.
12 Davis GL, Alter MJ, El-Serag H, Poynard T, Jennings LW. Aging of hepatitis C virus (HCV)-infected persons in the United States: A multiple cohort model of HCV prevalence and disease progression. Gastroenterology. 2010;138:513-521.
Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=6770407&lang=en
Vertex Contacts:
Media:
Dawn Kalmar, 617-444-6992
Amy Pasqua, 617-444-6992
Zachry Barber, 617-444-6992
mediainfo@vrtx.com
or
Patient Inquiries: 1-855- 837-3894
or
Investors:
Michael Partridge, 617-444-6108
Lora Pike, 617-444-6755
Matthew Osborne, 617-444-6057
Source: Vertex Pharmaceuticals Incorporated
Source
-INCIVEK was recently approved by the FDA and is now available for people with the most common form of chronic hepatitis C who are new to treatment and those who were treated before but not cured-
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the New England Journal of Medicine (NEJM) published data from two Phase 3 studies of INCIVEK™ (telaprevir) tablets, which showed that INCIVEK (in-SEE-veck) combination therapy significantly improved rates of sustained viral response (SVR, or viral cure) in a broad group of people with genotype 1 chronic hepatitis C who were new to treatment and those who were treated previously but not cured (relapsers, partial responders and null responders). Data from these studies, which included nearly 2,000 people, are published in the June 23, 2011 issue of NEJM.
In the ADVANCE study, INCIVEK combination therapy significantly improved viral cure rates in people who were new to treatment compared to those who received pegylated-interferon and ribavirin alone, two other medicines approved for hepatitis C. The majority of people who received INCIVEK combination therapy in this study were able to complete treatment in 24 weeks — half the time needed if they were to have taken pegylated-interferon and ribavirin alone. In the REALIZE study, which included people who were treated previously but not cured, viral cure rates were three-to-six-times higher with INCIVEK combination therapy compared to treatment with pegylated-interferon and ribavirin alone. Rash and anemia were the most common side effects reported with INCIVEK, which led to treatment discontinuation in about 1 percent of people in clinical studies.
"In the ADVANCE study, 79 percent of people with hepatitis C who had not been treated previously achieved a viral cure with INCIVEK combination therapy and the majority were able to cut treatment time in half," said Ira Jacobson, M.D., Chief of the Division of Gastroenterology and Hepatology, Weill Cornell Medical College, lead author and principal investigator for the ADVANCE study. "The results from this landmark study represent a paradigm shift in the treatment of hepatitis C and give us a new reason to encourage people to get tested and treated to potentially avoid the life-threatening consequences that can be associated with the disease."
"Many people with chronic hepatitis C who were treated previously but not cured have been waiting for new medicines, like INCIVEK, that offer a better chance to clear the virus," said Stefan Zeuzem, M.D., Professor of Medicine and Chief of the Department of Medicine at the JW Goethe University Hospital, Frankfurt, Germany, lead author and principal investigator for the REALIZE study. "In the REALIZE study, 86 percent of people who relapsed after being treated previously achieved a viral cure with INCIVEK combination therapy."
"The publication of these groundbreaking data follows the recent approval of INCIVEK, and it's exciting to know that some people are now completing their first month of INCIVEK combination treatment," said Peter Mueller, Ph.D., Chief Scientific Officer and Executive Vice President of Global Research and Development at Vertex.
On May 23, 2011, the U.S. Food and Drug Administration (FDA) approved INCIVEK for the treatment of genotype 1 chronic hepatitis C in adults with compensated liver disease (some level of damage to the liver but the liver still functions), including cirrhosis (scarring of the liver). The approval was based on data from three Phase 3 studies, including ADVANCE and REALIZE. The SVR (viral cure) rates included below are based on the approved analysis conducted by the FDA and Vertex and can be found in the Prescribing Information for INCIVEK.
People who received INCIVEK combination treatment achieved significantly higher rates of SVR, or viral cure, compared to those who received pegylated-interferon and ribavirin alone, regardless of prior treatment experience:
ADVANCE:
-- People new to treatment: 79 percent vs. 46 percent
REALIZE:
-- Relapsers: 86 percent vs. 22 percent
-- Partial responders: 59 percent vs. 15 percent
-- Null responders: 32 percent vs. 5 percent
INCIVEK was studied in all three groups of people who were treated previously but not cured. These groups included:
• Relapsers: defined as people whose hepatitis C virus was undetectable after a full course of previous treatment, but whose virus became detectable during the follow-up period;
• Partial responders: defined as people who achieved at least a 2 log10 reduction in hepatitis C virus at week 12, but whose hepatitis C virus never became undetectable by week 24 of a prior course of therapy; and
• Null responders: defined as people who achieved a less than 2 log10 reduction in hepatitis C virus at week 12 of a prior course of therapy. INCIVEK is the only newly approved medicine that has been studied in null responders.
Rash and anemia are the most serious side effects associated with INCIVEK. The most common side effects reported with INCIVEK combination treatment include fatigue, itching, nausea, diarrhea, vomiting, anal or rectal problems and taste changes.
For more information on INCIVEK, including full Prescribing Information, please visit http://www.incivek.com/.
About the ADVANCE and REALIZE Studies
ADVANCE and REALIZE were pivotal, Phase 3 randomized, double-blind, placebo-controlled, global studies, which evaluated INCIVEK in combination with Pegasys® (pegylated-interferon alfa-2a) and Copegus® (ribavirin). Both of these studies were part of a nearly 4,000-person clinical development program for INCIVEK. ADVANCE included 1,088 people who were new to treatment. REALIZE included 662 people who were treated previously but not cured, including relapsers, partial responders and null responders. The primary endpoint of these studies was SVR, or viral cure, in people who received INCIVEK combination therapy compared to those who received treatment with pegylated-interferon and ribavirin alone.
About INCIVEK
INCIVEK is an oral medicine that acts directly on the hepatitis C virus protease, an enzyme essential for viral replication. INCIVEK (750 mg) is given as two 375-mg tablets three-times daily for 12 weeks in combination with pegylated-interferon and ribavirin. Each monthly package of INCIVEK contains four weekly boxes that include daily blister strips to help patients keep track of their doses. After the first 12 weeks, all patients stop receiving INCIVEK and continue treatment with pegylated-interferon and ribavirin alone for an additional 12 weeks or 36 weeks of treatment. With INCIVEK combination therapy, more than 60 percent of people treated for the first time, as well as those who relapsed after previous therapy, are expected to complete all treatment in 24 weeks. All other patients receive a total of 48 weeks of treatment.
Vertex developed telaprevir in collaboration with Tibotec BVBA and Mitsubishi Tanabe Pharma. Vertex has rights to commercialize telaprevir in North America. Telaprevir was approved by the FDA in May 2011 and will be marketed in the United States under the brand name INCIVEK (in-SEE-veck). In Canada, telaprevir is under Priority Review by the Therapeutic Product Directorate (TPD) of Health Canada. Through its affiliate, Janssen, Tibotec has rights to commercialize telaprevir in Europe, South America, Australia, the Middle East and certain other countries. In December 2010, Janssen announced that the European Medicines Agency (EMA) accepted telaprevir for Accelerated Assessment in Europe. Mitsubishi Tanabe Pharma has rights to commercialize telaprevir in Japan and certain Far East countries.
Indication
INCIVEK™ (telaprevir) tablets is a prescription medicine used with the medicines peginterferon alfa and ribavirin to treat chronic (lasting a long time) hepatitis C genotype 1 infection in adults with stable liver problems, who have not been treated before or who have failed previous treatment.
It is not known if INCIVEK is safe and effective in children under 18 years of age.
IMPORTANT SAFETY INFORMATION
INCIVEK should always be taken in combination with peginterferon alfa and ribavirin. Ribavirin may cause birth defects or death of an unborn baby. Therefore, you should not take INCIVEK combination treatment if you are pregnant or may become pregnant, or if you are a man with a sexual partner who is pregnant.
INCIVEK and other medicines can affect each other and can also cause side effects that can be serious or life threatening. There are certain medicines you cannot take with INCIVEK combination treatment. Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements.
INCIVEK can cause serious side effects including rash and anemia. The most common side effects of INCIVEK include itching, nausea, diarrhea, vomiting, anal or rectal problems, taste changes and tiredness. There are other possible side effects of INCIVEK, and side effects associated with peginterferon alfa and ribavirin also apply to INCIVEK combination treatment. Tell your healthcare provider about any side effect that bothers you or doesn't go away.
Please see full Prescribing Information for INCIVEK, including the Medication Guide, available at http://www.incivek.com/.
You are encouraged to report negative side effects of prescription drugs to the FDA at 1-800-FDA-1088 OR 1-800-332-1088 or www.fda.gov/medwatch. You may also report side effects to Vertex at 1-877-824-4281 .
INCIVEK™ is a trademark of Vertex Pharmaceuticals Incorporated.
PEGASYS® and COPEGUS® are registered trademarks of Hoffmann-La Roche.
About Hepatitis C
Hepatitis C is a serious liver disease caused by the hepatitis C virus, which is spread through direct contact with the blood of infected people and ultimately affects the liver.1 Chronic hepatitis C can lead to serious and life-threatening liver problems, including liver damage, cirrhosis, liver failure or liver cancer.1 Though many people with hepatitis C may not experience symptoms, others may have symptoms such as fatigue, fever, jaundice and abdominal pain.1
Unlike HIV and hepatitis B virus, chronic hepatitis C is curable.2 However, approximately 60 percent of people do not achieve SVR,3,4,5 or viral cure,6 after treatment with 48 weeks of pegylated-interferon and ribavirin alone. If treatment is not successful and a person does not achieve a viral cure, they remain at an increased risk for progressive liver disease.7,8
More than 170 million people worldwide are chronically infected with hepatitis C.6 In the United States, nearly 4 million people have chronic hepatitis C and 75 percent of them are unaware of their infection.9 Hepatitis C is four times more prevalent in the United States compared to HIV.9 The majority of people with hepatitis C in the United States were born between 1946 and 1964, accounting for two of every three people with chronic hepatitis C.10 Hepatitis C is the leading cause of liver transplantations in the United States and is reported to contribute to 4,600 to 12,000 deaths annually.11,12 By 2029, total annual medical costs in the United States for people with hepatitis C are expected to more than double, from $30 billion in 2009 to approximately $85 billion.9
About Vertex
Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives. Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, epilepsy and other life-threatening diseases.
Founded more than 20 years ago in Cambridge, MA, we now have ongoing worldwide research programs and sites in the U.S., U.K. and Canada.
(VRTX - GEN)
1 Centers for Disease Control and Prevention. Hepatitis C Fact Sheet: CDC Viral Hepatitis. Available at: http://www.cdc.gov/hepatitis/HCV/PDFs/HepCGeneralFactSheet.pdf. Accessed March 21, 2011.
2 Pearlman BL and Traub N. Sustained Virologic Response to Antiviral Therapy for Chronic Hepatitis C Virus Infection: A Cure and So Much More. Clin Infect Dis. 2011 Apr;52(7):889-900.
3 Manns MP, McHutchison JG, Gordon SC, et al. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet. 2001;358:958-965.
4 Fried MW, Shiffman ML, Reddy KR, et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med. 2002;347:975-982.
5 McHutchison JG, Lawitz EJ, Shiffman ML, et al; IDEAL Study Team. Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection. N Engl J Med. 2009;361:580-593.
6 Ghany MG, Strader DB, Thomas DL, Seeff, LB. Diagnosis, management and treatment of hepatitis C; An update. Hepatology. 2009;49 (4):1-40.
7 Morgan TR, Ghany MG, Kim HY, Snow KK, Lindsay K, Lok AS. Outcome of sustained virological responders and non-responders in the Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis (HALT-C) trial. Hepatology. 2008;50(Suppl 4):357A (Abstract 115).
8 Veldt BJ, Heathcote J, Wedmeyer H. Sustained virologic response and clinical outcomes in patients with chronic hepatitis C and advanced fibrosis. Annals of Internal Medicine. 2007; 147: 677-684.
9 Institute of Medicine of the National Academies. Hepatitis and liver cancer: a national strategy for prevention and control of hepatitis B and C. Colvin HM and Mitchell AE, ed. Available at: http://www.iom.edu/Reports/2010/Hepatitis-and-Liver-Cancer-A-National-Strategy-for-Prevention-and-Control-of-Hepatitis-B-and-C.aspx. Updated January 11, 2010. Accessed March 21, 2011.
10 Pyenson B, Fitch K, Iwasaki K. Consequences of hepatitis C virus (HCV): Costs of a baby boomer epidemic of liver disease. Available at: http://www.natap.org/2009/HCV/051809_01.htm. Updated May 2009. Accessed March 21, 2011. This report was commissioned by Vertex Pharmaceuticals, Inc.
11 Volk MI, Tocco R, Saini S, Lok, ASF. Public health impact of antiviral therapy for hepatitis C in the United States. Hepatology. 2009;50(6):1750-1755.
12 Davis GL, Alter MJ, El-Serag H, Poynard T, Jennings LW. Aging of hepatitis C virus (HCV)-infected persons in the United States: A multiple cohort model of HCV prevalence and disease progression. Gastroenterology. 2010;138:513-521.
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Source: Vertex Pharmaceuticals Incorporated
Source
NEJM study: New drug represents breakthrough in treatment of hepatitis C
Public release date: 22-Jun-2011
Contact: Andrew Klein
ank2017@med.cornell.edu
212-821-0560\
New York- Presbyterian Hospital/Weill Cornell Medical Center/Weill Cornell Medical College
NewYork-Presbyterian/Weill Cornell physician-scientist leads study reporting that FDA-approved telaprevir-based regimen acts faster and offers a stronger viral cure than standard treatment
NEW YORK (June 23, 2011) -- The drug telaprevir (Incivek) provides a dramatic improvement in the treatment of the most common form of hepatitis C infection, says an international team of investigators led by Dr. Ira M. Jacobson of NewYork-Presbyterian Hospital/Weill Cornell Medical Center.
Their study, published in today's edition of the New England Journal of Medicine, led to approval of the agent for patient use by the U.S. Food and Drug Administration on May 23.
Results of the ADVANCE trial showed that telaprevir combined with standard therapy (pegylated-interferon and ribavirin) cured the virus in 75 percent of patients treated compared with 44 percent of patients who received standard therapy alone.
Furthermore, of the nearly 60 percent of telaprevir-treated patients who had undetectable viral levels at weeks 4 and 12 of treatment, and who were eligible by the terms of the study to receive 24 weeks of total treatment -- half the time required for standard treatment -- approximately 90 percent were cured.
Telaprevir represents a "quantum leap forward into a new era of hepatitis C therapy," says Dr. Jacobson, chief of the Division of Gastroenterology and Hepatology and the Vincent Astor Distinguished Professor of Medicine at NewYork-Presbyterian Hospital/Weill Cornell Medical Center. "This agent directly targets the virus and, together with the also recently introduced protease inhibitor boceprevir, is the first of a coming wave of new treatments that will help the medical community eradicate hepatitis C infection in a majority of patients."
More than 3 million people in the United States have chronic hepatitis C virus (HCV) infection. The infection, which is usually transmitted by blood, settles in the liver, which mounts a chronic immune response in an attempt to clear it. This persistent inflammation can lead to liver damage, cirrhosis or failure of the organ. Treatment to eradicate the virus often fails, leaving patients with few options other than a liver transplant.
Dr. Jacobson considers the approval of telaprevir to be a major breakthrough in the more than two-decade search for more effective HCV treatment. He was part of the first multicenter study of interferon therapy that stimulates the body's defenses against HCV, and he was also involved in studies that established that the addition of ribavirin to pegylated-interferon was beneficial as well as the initial studies demonstrating the effectiveness of interferon itself. In 1999, he helped create the Center for the Study of Hepatitis C and serves as the Center's medical director. A joint program of The Rockefeller University and NewYork-Presbyterian/Weill Cornell, the Center is a comprehensive, multidisciplinary center dedicated to the study of HCV and liver disease.
Telaprevir is similar in concept to drugs used to treat HIV. It is a protease inhibitor that shuts down the enzyme that processes the protein product of the viral genome after HCV infects human cells. The drug is effective against HCV genotype 1, which is responsible for nearly three-fourths of all hepatitis C infections in the United States and is also the predominant genotype in Europe, Japan and elsewhere.
In the ADVANCE clinical trial of which Dr. Jacobson served as principal investigator, 1,088 untreated patients diagnosed with HCV genotype 1 were assigned to one of three treatment arms: standard therapy for 48 weeks, or telaprevir combined with standard therapy for 8 or for 12 weeks, followed by standard therapy alone for a total treatment duration of either 24 or 48 weeks. The researchers found that sustained virologic response occurred in significantly more patients receiving 12 weeks (75 percent) or 8 weeks (69 percent) of telaprevir than with standard therapy alone (44 percent). (Note: The drug's package insert reflects higher SVR rates of 79 percent, 72 percent, and 46 percent, respectively, arising from revised analyses). In all, 58 percent of telaprevir-treated patients received 24 weeks of total treatment.
There were substantial benefits of telaprevir in subgroups of patients who do not generally respond well to standard therapy, Dr. Jacobson says. For example, 62 percent of participating African-American patients achieved a viral cure with the telaprevir-based regimen, compared with 25 percent of African-Americans treated with standard therapy. In addition, 62 percent of patients with advanced liver cirrhosis achieved a viral cure with telaprevir compared with 33 percent of similar patients on standard therapy. "We have closed the gap in cure in these populations," he says.
The results confirm the findings of the U.S. Phase 2 PROVE1 study, which was co-authored by Dr. Jacobson, and the European PROVE2 study; both studies were published April 30, 2009, in the New England Journal of Medicine.
Dr. Jacobson notes that telaprevir use does add to the side effects of standard therapy, but the marked increment of efficacy outweighs these side effects, adding that the risk-benefit ratio is very favorable for telaprevir.
"Telaprevir is not the end of the story. There are many exciting drugs being evaluated," he says. "Our most cherished goal is to cure HCV in all patients with a cocktail of fast-acting and well-tolerated drugs that have direct action against the virus or, in some cases, may target factors in the host that contribute to HCV replication or its consequent liver disease. Many lives will be saved."
###
Telaprevir was developed by Vertex Pharmaceuticals Incorporated in collaboration with Tibotec Pharmaceuticals and Mitsubishi Tanabe Pharma. Vertex provided funding for the study. Dr. Jacobson has received consulting fees and/or grant support from Vertex, Roche (maker of peginterferon and ribavirin) and Schering-Plough (maker of peginterferon and ribavirin).
Co-authors include Dr. John G. McHutchison and Dr. Andrew J. Muir from Duke Clinical Research Institute and Division of Gastroenterology, Duke University Medical Center, Durham, N.C.; Dr. Geoffrey Dusheiko, from Royal Free Hospital, Centre for Hepatology, London, United Kingdom; Dr. Adrian M. Di Bisceglie from Saint Louis University School of Medicine, Saint Louis, Mo.; Dr. K. Rajender Reddy from the University of Pennsylvania, Division of Gastroenterology, Philadelphia, Pa.; Dr. Natalie H. Bzowej from the California Pacific Medical Center, San Francisco, Calif.; Dr. Patrick Marcellin from Hôpital Beaujon, Service d'Hépatologie and INSERM CRB3, Clichy, France; Dr. Peter Ferenci from the University of Vienna, Vienna, Austria; Dr. Robert Flisiak from Medical University of Bialystok, Department of Infectious Diseases and Hepatology, Bialystok, Poland; Dr. Jacob George from Storr Liver Unit, Westmead Millennium Institute for Medical Research and Westmead Hospital, University of Sydney, Westmead, Australia; Dr. Mario Rizzetto from the University of Turin, Department of Gastroenterology, Turin, Italy; Dr. Daniel Shouval from Hadassah-Hebrew University Hospital, Liver Unit, Jerusalem, Israel; Dr. Ricard Sola from Hospital del Mar, IMIM, Universitat Autónoma de Barcelona, Barcelona, Spain; Dr. Ruben A. Terg from Hospital de GastroenterologÃa Dr Bonorino Udaondo, Buenos Aires, Argentina; Dr. Eric M. Yoshida from the University of British Columbia and Vancouver General Hospital, Vancouver, B.C., Canada; Dr. Nathalie Adda, Leif Bengtsson, Dr. Abdul J. Sankoh, Dr. Tara L. Kieffer, Dr. Shelley George and Dr. Robert S. Kauffman from Vertex Pharmaceuticals Incorporated, Cambridge, Mass.; and Dr. Stefan Zeuzem from Johann Wolfgang Goethe University Medical Center, Department of Internal Medicine, Frankfurt am Main, Germany, for the ADVANCE Study Team.
For more information, patients may call (866) NYP-NEWS .
NewYork-Presbyterian Hospital/Weill Cornell Medical Center
NewYork-Presbyterian Hospital/Weill Cornell Medical Center, located in New York City, is one of the leading academic medical centers in the world, comprising the teaching hospital NewYork-Presbyterian and Weill Cornell Medical College, the medical school of Cornell University. NewYork-Presbyterian/Weill Cornell provides state-of-the-art inpatient, ambulatory and preventive care in all areas of medicine, and is committed to excellence in patient care, education, research and community service. Weill Cornell physician-scientists have been responsible for many medical advances -- including the development of the Pap test for cervical cancer; the synthesis of penicillin; the first successful embryo-biopsy pregnancy and birth in the U.S.; the first clinical trial for gene therapy for Parkinson's disease; the first indication of bone marrow's critical role in tumor growth; and, most recently, the world's first successful use of deep brain stimulation to treat a minimally conscious brain-injured patient. NewYork-Presbyterian Hospital also comprises NewYork-Presbyterian Hospital/Columbia University Medical Center, NewYork-Presbyterian/Morgan Stanley Children's Hospital, NewYork-Presbyterian Hospital/Westchester Division and NewYork-Presbyterian/The Allen Hospital. NewYork-Presbyterian is the #1 hospital in the New York metropolitan area and is consistently ranked among the best academic medical institutions in the nation, according to U.S.News & World Report. Weill Cornell Medical College is the first U.S. medical college to offer a medical degree overseas and maintains a strong global presence in Austria, Brazil, Haiti, Tanzania, Turkey and Qatar. For more information, visit http://www.nyp.org/ and weill.cornell.edu.
Source
Contact: Andrew Klein
ank2017@med.cornell.edu
212-821-0560\
New York- Presbyterian Hospital/Weill Cornell Medical Center/Weill Cornell Medical College
NewYork-Presbyterian/Weill Cornell physician-scientist leads study reporting that FDA-approved telaprevir-based regimen acts faster and offers a stronger viral cure than standard treatment
NEW YORK (June 23, 2011) -- The drug telaprevir (Incivek) provides a dramatic improvement in the treatment of the most common form of hepatitis C infection, says an international team of investigators led by Dr. Ira M. Jacobson of NewYork-Presbyterian Hospital/Weill Cornell Medical Center.
Their study, published in today's edition of the New England Journal of Medicine, led to approval of the agent for patient use by the U.S. Food and Drug Administration on May 23.
Results of the ADVANCE trial showed that telaprevir combined with standard therapy (pegylated-interferon and ribavirin) cured the virus in 75 percent of patients treated compared with 44 percent of patients who received standard therapy alone.
Furthermore, of the nearly 60 percent of telaprevir-treated patients who had undetectable viral levels at weeks 4 and 12 of treatment, and who were eligible by the terms of the study to receive 24 weeks of total treatment -- half the time required for standard treatment -- approximately 90 percent were cured.
Telaprevir represents a "quantum leap forward into a new era of hepatitis C therapy," says Dr. Jacobson, chief of the Division of Gastroenterology and Hepatology and the Vincent Astor Distinguished Professor of Medicine at NewYork-Presbyterian Hospital/Weill Cornell Medical Center. "This agent directly targets the virus and, together with the also recently introduced protease inhibitor boceprevir, is the first of a coming wave of new treatments that will help the medical community eradicate hepatitis C infection in a majority of patients."
More than 3 million people in the United States have chronic hepatitis C virus (HCV) infection. The infection, which is usually transmitted by blood, settles in the liver, which mounts a chronic immune response in an attempt to clear it. This persistent inflammation can lead to liver damage, cirrhosis or failure of the organ. Treatment to eradicate the virus often fails, leaving patients with few options other than a liver transplant.
Dr. Jacobson considers the approval of telaprevir to be a major breakthrough in the more than two-decade search for more effective HCV treatment. He was part of the first multicenter study of interferon therapy that stimulates the body's defenses against HCV, and he was also involved in studies that established that the addition of ribavirin to pegylated-interferon was beneficial as well as the initial studies demonstrating the effectiveness of interferon itself. In 1999, he helped create the Center for the Study of Hepatitis C and serves as the Center's medical director. A joint program of The Rockefeller University and NewYork-Presbyterian/Weill Cornell, the Center is a comprehensive, multidisciplinary center dedicated to the study of HCV and liver disease.
Telaprevir is similar in concept to drugs used to treat HIV. It is a protease inhibitor that shuts down the enzyme that processes the protein product of the viral genome after HCV infects human cells. The drug is effective against HCV genotype 1, which is responsible for nearly three-fourths of all hepatitis C infections in the United States and is also the predominant genotype in Europe, Japan and elsewhere.
In the ADVANCE clinical trial of which Dr. Jacobson served as principal investigator, 1,088 untreated patients diagnosed with HCV genotype 1 were assigned to one of three treatment arms: standard therapy for 48 weeks, or telaprevir combined with standard therapy for 8 or for 12 weeks, followed by standard therapy alone for a total treatment duration of either 24 or 48 weeks. The researchers found that sustained virologic response occurred in significantly more patients receiving 12 weeks (75 percent) or 8 weeks (69 percent) of telaprevir than with standard therapy alone (44 percent). (Note: The drug's package insert reflects higher SVR rates of 79 percent, 72 percent, and 46 percent, respectively, arising from revised analyses). In all, 58 percent of telaprevir-treated patients received 24 weeks of total treatment.
There were substantial benefits of telaprevir in subgroups of patients who do not generally respond well to standard therapy, Dr. Jacobson says. For example, 62 percent of participating African-American patients achieved a viral cure with the telaprevir-based regimen, compared with 25 percent of African-Americans treated with standard therapy. In addition, 62 percent of patients with advanced liver cirrhosis achieved a viral cure with telaprevir compared with 33 percent of similar patients on standard therapy. "We have closed the gap in cure in these populations," he says.
The results confirm the findings of the U.S. Phase 2 PROVE1 study, which was co-authored by Dr. Jacobson, and the European PROVE2 study; both studies were published April 30, 2009, in the New England Journal of Medicine.
Dr. Jacobson notes that telaprevir use does add to the side effects of standard therapy, but the marked increment of efficacy outweighs these side effects, adding that the risk-benefit ratio is very favorable for telaprevir.
"Telaprevir is not the end of the story. There are many exciting drugs being evaluated," he says. "Our most cherished goal is to cure HCV in all patients with a cocktail of fast-acting and well-tolerated drugs that have direct action against the virus or, in some cases, may target factors in the host that contribute to HCV replication or its consequent liver disease. Many lives will be saved."
###
Telaprevir was developed by Vertex Pharmaceuticals Incorporated in collaboration with Tibotec Pharmaceuticals and Mitsubishi Tanabe Pharma. Vertex provided funding for the study. Dr. Jacobson has received consulting fees and/or grant support from Vertex, Roche (maker of peginterferon and ribavirin) and Schering-Plough (maker of peginterferon and ribavirin).
Co-authors include Dr. John G. McHutchison and Dr. Andrew J. Muir from Duke Clinical Research Institute and Division of Gastroenterology, Duke University Medical Center, Durham, N.C.; Dr. Geoffrey Dusheiko, from Royal Free Hospital, Centre for Hepatology, London, United Kingdom; Dr. Adrian M. Di Bisceglie from Saint Louis University School of Medicine, Saint Louis, Mo.; Dr. K. Rajender Reddy from the University of Pennsylvania, Division of Gastroenterology, Philadelphia, Pa.; Dr. Natalie H. Bzowej from the California Pacific Medical Center, San Francisco, Calif.; Dr. Patrick Marcellin from Hôpital Beaujon, Service d'Hépatologie and INSERM CRB3, Clichy, France; Dr. Peter Ferenci from the University of Vienna, Vienna, Austria; Dr. Robert Flisiak from Medical University of Bialystok, Department of Infectious Diseases and Hepatology, Bialystok, Poland; Dr. Jacob George from Storr Liver Unit, Westmead Millennium Institute for Medical Research and Westmead Hospital, University of Sydney, Westmead, Australia; Dr. Mario Rizzetto from the University of Turin, Department of Gastroenterology, Turin, Italy; Dr. Daniel Shouval from Hadassah-Hebrew University Hospital, Liver Unit, Jerusalem, Israel; Dr. Ricard Sola from Hospital del Mar, IMIM, Universitat Autónoma de Barcelona, Barcelona, Spain; Dr. Ruben A. Terg from Hospital de GastroenterologÃa Dr Bonorino Udaondo, Buenos Aires, Argentina; Dr. Eric M. Yoshida from the University of British Columbia and Vancouver General Hospital, Vancouver, B.C., Canada; Dr. Nathalie Adda, Leif Bengtsson, Dr. Abdul J. Sankoh, Dr. Tara L. Kieffer, Dr. Shelley George and Dr. Robert S. Kauffman from Vertex Pharmaceuticals Incorporated, Cambridge, Mass.; and Dr. Stefan Zeuzem from Johann Wolfgang Goethe University Medical Center, Department of Internal Medicine, Frankfurt am Main, Germany, for the ADVANCE Study Team.
For more information, patients may call (866) NYP-NEWS .
NewYork-Presbyterian Hospital/Weill Cornell Medical Center
NewYork-Presbyterian Hospital/Weill Cornell Medical Center, located in New York City, is one of the leading academic medical centers in the world, comprising the teaching hospital NewYork-Presbyterian and Weill Cornell Medical College, the medical school of Cornell University. NewYork-Presbyterian/Weill Cornell provides state-of-the-art inpatient, ambulatory and preventive care in all areas of medicine, and is committed to excellence in patient care, education, research and community service. Weill Cornell physician-scientists have been responsible for many medical advances -- including the development of the Pap test for cervical cancer; the synthesis of penicillin; the first successful embryo-biopsy pregnancy and birth in the U.S.; the first clinical trial for gene therapy for Parkinson's disease; the first indication of bone marrow's critical role in tumor growth; and, most recently, the world's first successful use of deep brain stimulation to treat a minimally conscious brain-injured patient. NewYork-Presbyterian Hospital also comprises NewYork-Presbyterian Hospital/Columbia University Medical Center, NewYork-Presbyterian/Morgan Stanley Children's Hospital, NewYork-Presbyterian Hospital/Westchester Division and NewYork-Presbyterian/The Allen Hospital. NewYork-Presbyterian is the #1 hospital in the New York metropolitan area and is consistently ranked among the best academic medical institutions in the nation, according to U.S.News & World Report. Weill Cornell Medical College is the first U.S. medical college to offer a medical degree overseas and maintains a strong global presence in Austria, Brazil, Haiti, Tanzania, Turkey and Qatar. For more information, visit http://www.nyp.org/ and weill.cornell.edu.
Source
Drug Ups Response Rate in Refractory Hepatitis C
By Michael Smith, North American Correspondent, MedPage Today
Published: June 22, 2011
Reviewed by Dori F. Zaleznik, MD; Associate Clinical Professor of Medicine, Harvard Medical School, Boston.
The protease inhibitor, telaprevir (Incivek), markedly improved response rates in patients with difficult-to-treat hepatitis C virus (HCV) infection, compared with standard therapy, according to two studies reported in the June 23 issue of the New England Journal of Medicine.
The improvement was particularly dramatic among patients who had previously failed standard therapy, according to Stefan Zeuzem, MD, of Johann Wolfgang Goethe University Hospital in Frankfurt, Germany, and colleagues.
In one arm of their REALIZE study, 88% of patients getting telaprevir, in combination with standard therapy, had a sustained virological response (SVR), defined as no detectable virus 24 weeks after the final treatment dose.
In contrast, just 24% of patients attempting standard therapy for a second time had a sustained response, Zeuzem and colleagues reported.
Only about 40% of patients with the most difficult-to-treat variety of HCV, the so-called genotype 1, respond to standard treatment with pegylated interferon alfa-2a and ribavirin.
But in the ADVANCE study, the second one in this issue of the journal, the rate of sustained virological response among treatment-naive patients was between 69% and 75%, depending on the exact regimen, according to Ira Jacobson, MD, of the Weill Cornell Medical College in New York City, and colleagues.
In contrast, just 44% of patients who got standard therapy had a sustained response, the researchers reported.
When the FDA approved the drug in May, a company spokesman told MedPage Today, the agency used a slightly different method of calculating SVR rates. As a result, the labeling for the drug says that in treatment-naive patients the best SVR rate is 79%.
Telaprevir is the second protease inhibitor to be approved for hepatitis C; earlier in May, the FDA okayed boceprevir (Victrelis).
In the REALIZE trial, researchers enrolled 663 patients with genotype 1 hepatitis C who had either not responded, had a partial response, or had relapsed after an initial response to standard therapy.
They were randomly assigned to three groups, Zeuzem and colleagues reported.
In the so-called T12PR48 group, patients got telaprevir for 12 weeks, along with peginterferon plus ribavirin, followed by peginterferon plus ribavirin alone for a total of 48 weeks of therapy.
In the "lead-in group" patients started with four weeks of peginterferon plus ribavirin followed by the T12PR48 regimen.
In the control group -- dubbed PR48 – patients were treated with peginterferon and ribavirin for 48 weeks.
The researchers found:
• SVR rates among patients who had a previous relapse were 83% in the T12PR48 group, 88% in the lead-in group, and 24% in the control group.
• Among those who had a previous partial response, the rates were 59%, 54%, and 15%, respectively.
• In those who had not responded to their first therapy, the rates were 29%, 33%, and 5%, respectively.
• The comparisons were all significant at P<0.001.
Grade three adverse events were mainly anemia, neutropenia, and leukopenia and were reported by 37% of patients in the telaprevir groups, compared with 22% in the control group.
But the most common side effects, reported by more than 25% of patients, were fatigue, pruritus, rash, nausea, influenza-like illness, anemia, and diarrhea.
The researchers were especially concerned about rash, because there have been reported cases of Stevens-Johnson syndrome among telaprevir patients. In this study, grade three rash, any skin event resulting in permanent discontinuation of study drugs, or any skin event defined as a serious adverse event occurred in 5% of patients in the two telaprevir groups, as compared with none in the control group.
The ADVANCE study, in 1,088 treatment-naive patients, also had a three-arm design, Jacobson and colleagues reported, although it was slightly more complicated.
As in the other trial, the control group was assigned to get peginterferon and ribavirin for 48 weeks, but with the addition of a placebo for the first 12 weeks.
In one active arm – dubbed T12PR – patients got all three drugs for 12 weeks, followed by peginterferon/ribavirin alone for 12 weeks if the virus was undetectable at weeks four and 12 or for 36 weeks if it was found at either point.
In the other arm, called T8PR, patients got all three drugs for eight weeks, followed by a placebo and peginterferon/ribavirin for four weeks. This was followed by either 12 or 36 weeks of peginterferon/ribavirin, based on the same criteria used in the T12PR group.
Jacobson and colleagues found:
• SVR rate in the control group was 44%, comparable with rates previously seen with standard therapy.
• SVR rate in the T12PR group was 75%, while the rate in the T8PR group was 69%. Both differences were significant from the control group at P<0.001.
• 58% of telaprevir patients responded early enough so that the treatment could be truncated to 24 weeks in total.
The researchers said the rates of nausea, diarrhea, pruritus, rash, and anemia were at least 10 percentage points higher in each of the telaprevir groups than in the control group.
Development of a rash caused 7% of patients in the T12PR group and 5% in the T8PR group to stop telaprevir, and 1.4% and 0.5%, respectively, to stop all treatment, Jacobson and colleagues reported.
Rashes were primarily eczema and were reversible with discontinuation of telaprevir, they said, noting that one case of Stevens–Johnson syndrome occurred about 11 weeks after the patient's last dose of telaprevir.
Both studies were supported by Tibotec and Vertex Pharmaceuticals. Several authors in both cases are employees of one of the companies.
Jacobson reported financial links with Abbott, Achillion Pharmaceuticals, Anadys Pharmaceuticals, Biolex Therapeutics, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, GlobeImmune, Human Genome Sciences, Novartis, Pharmasset, Pfizer, Roche–Genentech, sanofi-aventis, Schering-Plough (now part of Merck), Tibotec, Vertex Pharmaceuticals, and ZymoGenetics,
Zeuzem reported financial links with Abbott, Achillion Pharmaceuticals, Anadys Pharmaceuticals, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, Human Genome Sciences, iTherX, Novartis, Pfizer, Pharmasset, Roche–Genentech, Santaris Pharma, Schering-Plough (Merck), Tibotec, and Vertex Pharmaceuticals.
Primary source: New England Journal of Medicine
Source reference:
Jacobson IM, et al "Telaprevir for previously untreated chronic hepatitis C virus infection" N Engl J Med 2011; 364: 2405-2416.
Additional source: New England Journal of Medicine
Source reference:
Zeuzem S, et al "Telaprevir for retreatment of HCV infection" N Engl J Med 2011; 364: 2417-2428.
Source
Published: June 22, 2011
Reviewed by Dori F. Zaleznik, MD; Associate Clinical Professor of Medicine, Harvard Medical School, Boston.
The protease inhibitor, telaprevir (Incivek), markedly improved response rates in patients with difficult-to-treat hepatitis C virus (HCV) infection, compared with standard therapy, according to two studies reported in the June 23 issue of the New England Journal of Medicine.
The improvement was particularly dramatic among patients who had previously failed standard therapy, according to Stefan Zeuzem, MD, of Johann Wolfgang Goethe University Hospital in Frankfurt, Germany, and colleagues.
In one arm of their REALIZE study, 88% of patients getting telaprevir, in combination with standard therapy, had a sustained virological response (SVR), defined as no detectable virus 24 weeks after the final treatment dose.
In contrast, just 24% of patients attempting standard therapy for a second time had a sustained response, Zeuzem and colleagues reported.
Only about 40% of patients with the most difficult-to-treat variety of HCV, the so-called genotype 1, respond to standard treatment with pegylated interferon alfa-2a and ribavirin.
But in the ADVANCE study, the second one in this issue of the journal, the rate of sustained virological response among treatment-naive patients was between 69% and 75%, depending on the exact regimen, according to Ira Jacobson, MD, of the Weill Cornell Medical College in New York City, and colleagues.
In contrast, just 44% of patients who got standard therapy had a sustained response, the researchers reported.
When the FDA approved the drug in May, a company spokesman told MedPage Today, the agency used a slightly different method of calculating SVR rates. As a result, the labeling for the drug says that in treatment-naive patients the best SVR rate is 79%.
Telaprevir is the second protease inhibitor to be approved for hepatitis C; earlier in May, the FDA okayed boceprevir (Victrelis).
In the REALIZE trial, researchers enrolled 663 patients with genotype 1 hepatitis C who had either not responded, had a partial response, or had relapsed after an initial response to standard therapy.
They were randomly assigned to three groups, Zeuzem and colleagues reported.
In the so-called T12PR48 group, patients got telaprevir for 12 weeks, along with peginterferon plus ribavirin, followed by peginterferon plus ribavirin alone for a total of 48 weeks of therapy.
In the "lead-in group" patients started with four weeks of peginterferon plus ribavirin followed by the T12PR48 regimen.
In the control group -- dubbed PR48 – patients were treated with peginterferon and ribavirin for 48 weeks.
The researchers found:
• SVR rates among patients who had a previous relapse were 83% in the T12PR48 group, 88% in the lead-in group, and 24% in the control group.
• Among those who had a previous partial response, the rates were 59%, 54%, and 15%, respectively.
• In those who had not responded to their first therapy, the rates were 29%, 33%, and 5%, respectively.
• The comparisons were all significant at P<0.001.
Grade three adverse events were mainly anemia, neutropenia, and leukopenia and were reported by 37% of patients in the telaprevir groups, compared with 22% in the control group.
But the most common side effects, reported by more than 25% of patients, were fatigue, pruritus, rash, nausea, influenza-like illness, anemia, and diarrhea.
The researchers were especially concerned about rash, because there have been reported cases of Stevens-Johnson syndrome among telaprevir patients. In this study, grade three rash, any skin event resulting in permanent discontinuation of study drugs, or any skin event defined as a serious adverse event occurred in 5% of patients in the two telaprevir groups, as compared with none in the control group.
The ADVANCE study, in 1,088 treatment-naive patients, also had a three-arm design, Jacobson and colleagues reported, although it was slightly more complicated.
As in the other trial, the control group was assigned to get peginterferon and ribavirin for 48 weeks, but with the addition of a placebo for the first 12 weeks.
In one active arm – dubbed T12PR – patients got all three drugs for 12 weeks, followed by peginterferon/ribavirin alone for 12 weeks if the virus was undetectable at weeks four and 12 or for 36 weeks if it was found at either point.
In the other arm, called T8PR, patients got all three drugs for eight weeks, followed by a placebo and peginterferon/ribavirin for four weeks. This was followed by either 12 or 36 weeks of peginterferon/ribavirin, based on the same criteria used in the T12PR group.
Jacobson and colleagues found:
• SVR rate in the control group was 44%, comparable with rates previously seen with standard therapy.
• SVR rate in the T12PR group was 75%, while the rate in the T8PR group was 69%. Both differences were significant from the control group at P<0.001.
• 58% of telaprevir patients responded early enough so that the treatment could be truncated to 24 weeks in total.
The researchers said the rates of nausea, diarrhea, pruritus, rash, and anemia were at least 10 percentage points higher in each of the telaprevir groups than in the control group.
Development of a rash caused 7% of patients in the T12PR group and 5% in the T8PR group to stop telaprevir, and 1.4% and 0.5%, respectively, to stop all treatment, Jacobson and colleagues reported.
Rashes were primarily eczema and were reversible with discontinuation of telaprevir, they said, noting that one case of Stevens–Johnson syndrome occurred about 11 weeks after the patient's last dose of telaprevir.
Both studies were supported by Tibotec and Vertex Pharmaceuticals. Several authors in both cases are employees of one of the companies.
Jacobson reported financial links with Abbott, Achillion Pharmaceuticals, Anadys Pharmaceuticals, Biolex Therapeutics, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, GlobeImmune, Human Genome Sciences, Novartis, Pharmasset, Pfizer, Roche–Genentech, sanofi-aventis, Schering-Plough (now part of Merck), Tibotec, Vertex Pharmaceuticals, and ZymoGenetics,
Zeuzem reported financial links with Abbott, Achillion Pharmaceuticals, Anadys Pharmaceuticals, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, Human Genome Sciences, iTherX, Novartis, Pfizer, Pharmasset, Roche–Genentech, Santaris Pharma, Schering-Plough (Merck), Tibotec, and Vertex Pharmaceuticals.
Primary source: New England Journal of Medicine
Source reference:
Jacobson IM, et al "Telaprevir for previously untreated chronic hepatitis C virus infection" N Engl J Med 2011; 364: 2405-2416.
Additional source: New England Journal of Medicine
Source reference:
Zeuzem S, et al "Telaprevir for retreatment of HCV infection" N Engl J Med 2011; 364: 2417-2428.
Source
June 21, 2011
Telaprevir-Based HCV Treatment Benefits All IL28B Genotypes
Caroline Helwick
May 24, 2011 (Chicago, Illinois) — The direct-acting protease inhibitor telaprevir, given in combination with pegylated interferon plus peginterferon/ribavirin (PR), increased the chance of sustained viral response (SVR) across all interleukin (IL) 28B genotypes of hepatitis C virus (HCV), results of a substudy of the ADVANCE trial have shown.
The findings were reported here at Digestive Disease Week 2011 by Ira Jacobson, MD, chief of the division of gastroenterology and hepatology at New York–Presbyterian Hospital/Weill Cornell Medical Center, and Vincent Astor Distinguished Professor of Medicine at Weill Cornell Medical College in New York City. Dr. Jacobson is also principal investigator for the ADVANCE study.
"Single-nucleotide polymorphisms near the IL28B gene have been strongly associated with the likelihood of SVR in genotype 1 HCV patients treated with PR. During our evaluation of an exploratory diagnostic test that characterizes genetic polymorphisms near the IL28B gene, we investigated the impact of the IL28B genotype on SVR rates in the telaprevir-based regimens," Dr. Jacobson said.
The 3 variations of the IL28B genotype have been associated with a person's response to hepatitis C treatment with PR, Dr. Jacobson noted. In this study, substantial improvements were observed in SVR, or viral cure, across all IL28B genotypes — CC, CT, and TT — for patients treated with telaprevir-based combination therapy, he reported.
In ADVANCE, patients were randomized to receive telaprevir (for 8 weeks or 12 weeks) in combination with PR, followed by PR alone, for a total of either 24 weeks or 48 weeks of treatment. In the response-guided regimen, eligibility for the shorter treatment duration was based on having undetectable HCV at weeks 4 and 12.
The IL28B allele distribution in a sample of 454 patients for whom genotyping was available was consistent with previous reports for treatment-naïve patients: 49% had the CT genotype, 33% had the CC genotype, and 18% had the TT genotype.
The SVR rates in these 454 white patients were 78% for the 12-week telaprevir-based regimen, 65% for the 8-week telaprevir-based regimen, and 38% for the control group treated only with PR.
Patients with the CC allele were the most likely to achieve an SVR, which reached 90% with the 12-week regimen and 84% with the 8-week regimen. In the CC allele population receiving only PR, 68% achieved an SVR. In the other 2 allele subsets receiving 12 weeks of telaprevir, SVR was achieved by 71% of CT patients and 73% of TT patients; in those receiving PR only, SVR was achieved by 25% of CT patients and 23% of TT patients.
"You see that the largest increment in SVR occurred in patients with the T allele," Dr. Jacobson pointed out. Rates exceeded 70%, compared with 25% or less with PR only.
With the 8-week regimen, SVR rates were 57% and 59%, respectively, compared with 25% and 23%, respectively, for the PR regimen in these genotype subsets.
Telaprevir-based regimens also improved rapid viral responses (RVRs) and extended (e)RVR rates across all IL28B genotypes, meaning they had undetectable HCV RNA at weeks 4 and 12. The eRVR rate in the 12-week group was higher than in the placebo group for CC patients (78% vs 15%), for CT patients (57% vs 2%), and for TT patients (45% vs 0%).
"Most eRVR patients achieved an SVR in all groups," he added, including 95% of the CC group, 92% of the CT group, and 80% of the TT group receiving 12 weeks of telaprevir plus PR. "Patients with an eRVR were highly likely to achieve SVR as well."
Nonattainment of eRVR was associated with lower SVR rates across all IL28B genotypes, with the largest decrement in CT/TT patients, the study found.
Andrew Muir, MD, clinical director of hepatology at Duke University Medical Center, Durham, North Carolina, told Medscape Medical News that these findings confirm that all patients benefit from the addition of telaprevir, regardless of their IL28B genotype.
When it became clear that the CC genotype is associated with higher response rates, patients who learned they had the CT or TT genotype tended to have concerns, Dr. Muir said. "These findings change that discussion a lot," he noted. "Those patients now see that they can benefit from treatment as well."
The other value of the study is the finding that a patient is more likely to benefit from a shorter course of treatment if he or she [has genotype] CC," he added. "This may be relevant to some patients — that is, it may make a difference in their enthusiasm for treatment. It's important to have this information in your discussions with patients."
Telaprevir was just approved by the US Food and Drug Administration for the treatment of HCV.
Dr. Jacobson reports receiving grant and research support, consulting fees, and other financial benefit from Vertex Pharmaceuticals. Dr. Muir reports financial relationships with Anadys, Genentech, Idera, Medtronic, Merck & Co, Pharmasset, Santarus, Scynexis, Three Rivers Pharmaceuticals, Vertex, and ZymoGenetics.
Digestive Disease Week (DDW) 2011: Abstract 904. Presented May 10, 2011.
Source
May 24, 2011 (Chicago, Illinois) — The direct-acting protease inhibitor telaprevir, given in combination with pegylated interferon plus peginterferon/ribavirin (PR), increased the chance of sustained viral response (SVR) across all interleukin (IL) 28B genotypes of hepatitis C virus (HCV), results of a substudy of the ADVANCE trial have shown.
The findings were reported here at Digestive Disease Week 2011 by Ira Jacobson, MD, chief of the division of gastroenterology and hepatology at New York–Presbyterian Hospital/Weill Cornell Medical Center, and Vincent Astor Distinguished Professor of Medicine at Weill Cornell Medical College in New York City. Dr. Jacobson is also principal investigator for the ADVANCE study.
"Single-nucleotide polymorphisms near the IL28B gene have been strongly associated with the likelihood of SVR in genotype 1 HCV patients treated with PR. During our evaluation of an exploratory diagnostic test that characterizes genetic polymorphisms near the IL28B gene, we investigated the impact of the IL28B genotype on SVR rates in the telaprevir-based regimens," Dr. Jacobson said.
The 3 variations of the IL28B genotype have been associated with a person's response to hepatitis C treatment with PR, Dr. Jacobson noted. In this study, substantial improvements were observed in SVR, or viral cure, across all IL28B genotypes — CC, CT, and TT — for patients treated with telaprevir-based combination therapy, he reported.
In ADVANCE, patients were randomized to receive telaprevir (for 8 weeks or 12 weeks) in combination with PR, followed by PR alone, for a total of either 24 weeks or 48 weeks of treatment. In the response-guided regimen, eligibility for the shorter treatment duration was based on having undetectable HCV at weeks 4 and 12.
The IL28B allele distribution in a sample of 454 patients for whom genotyping was available was consistent with previous reports for treatment-naïve patients: 49% had the CT genotype, 33% had the CC genotype, and 18% had the TT genotype.
The SVR rates in these 454 white patients were 78% for the 12-week telaprevir-based regimen, 65% for the 8-week telaprevir-based regimen, and 38% for the control group treated only with PR.
Patients with the CC allele were the most likely to achieve an SVR, which reached 90% with the 12-week regimen and 84% with the 8-week regimen. In the CC allele population receiving only PR, 68% achieved an SVR. In the other 2 allele subsets receiving 12 weeks of telaprevir, SVR was achieved by 71% of CT patients and 73% of TT patients; in those receiving PR only, SVR was achieved by 25% of CT patients and 23% of TT patients.
"You see that the largest increment in SVR occurred in patients with the T allele," Dr. Jacobson pointed out. Rates exceeded 70%, compared with 25% or less with PR only.
With the 8-week regimen, SVR rates were 57% and 59%, respectively, compared with 25% and 23%, respectively, for the PR regimen in these genotype subsets.
Telaprevir-based regimens also improved rapid viral responses (RVRs) and extended (e)RVR rates across all IL28B genotypes, meaning they had undetectable HCV RNA at weeks 4 and 12. The eRVR rate in the 12-week group was higher than in the placebo group for CC patients (78% vs 15%), for CT patients (57% vs 2%), and for TT patients (45% vs 0%).
"Most eRVR patients achieved an SVR in all groups," he added, including 95% of the CC group, 92% of the CT group, and 80% of the TT group receiving 12 weeks of telaprevir plus PR. "Patients with an eRVR were highly likely to achieve SVR as well."
Nonattainment of eRVR was associated with lower SVR rates across all IL28B genotypes, with the largest decrement in CT/TT patients, the study found.
Andrew Muir, MD, clinical director of hepatology at Duke University Medical Center, Durham, North Carolina, told Medscape Medical News that these findings confirm that all patients benefit from the addition of telaprevir, regardless of their IL28B genotype.
When it became clear that the CC genotype is associated with higher response rates, patients who learned they had the CT or TT genotype tended to have concerns, Dr. Muir said. "These findings change that discussion a lot," he noted. "Those patients now see that they can benefit from treatment as well."
The other value of the study is the finding that a patient is more likely to benefit from a shorter course of treatment if he or she [has genotype] CC," he added. "This may be relevant to some patients — that is, it may make a difference in their enthusiasm for treatment. It's important to have this information in your discussions with patients."
Telaprevir was just approved by the US Food and Drug Administration for the treatment of HCV.
Dr. Jacobson reports receiving grant and research support, consulting fees, and other financial benefit from Vertex Pharmaceuticals. Dr. Muir reports financial relationships with Anadys, Genentech, Idera, Medtronic, Merck & Co, Pharmasset, Santarus, Scynexis, Three Rivers Pharmaceuticals, Vertex, and ZymoGenetics.
Digestive Disease Week (DDW) 2011: Abstract 904. Presented May 10, 2011.
Source
High Demand for New HCV Drugs Could Cause Ethical Problems
Jim Kling
May 27, 2011 — Earlier this month, the US Food and Drug Administration approved the drugs boceprevir (Victrelis, Merck) and telaprevir (Incivek, Vertex) for the treatment of hepatitis C virus (HCV) infection. The approvals are good news for patients with HCV, but high patient demand could lead to scarcity and ethical challenges for treatment providers, according to a viewpoint article published in the June issue of Hepatology.
HCV is responsible for 120 million infections worldwide and is a leading cause of liver failure mortality, explain authors Andrew Aronsohn, MD, and Donald Jensen, MD, from the Center for Liver Disease, Section of Gastroenterology, Hepatology, and Nutrition, University of Chicago Medical Center, Illinois. Pegylated interferon and ribavarin have had some effect, but less than half of patients with HCV achieve a sustained virologic response.
Clinical trial results suggest telaprevir and boceprevir will achieve marked improvement in sustained virologic responses in genotype 1 patients compared with current standard of care therapy.
Some patients who are at low risk for near-future progression have deferred therapy in anticipation of the arrival of these drugs. A recent Veterans' Administration study revealed that 50.3% of patients who refused treatment with interferon and ribavirin did so in anticipation of more effective drugs.
These patients will add to the demand for the drugs, complicating efforts to monitor and educate patients, which is already challenging because treatment regimens are complex. In addition, it could place undue demand on healthcare providers. The authors conducted a time analysis study at their own institution and found that the average healthcare provider could initiate treatment in 3 patients with HCV in a week. They anticipate receiving 500 new patients in the weeks after approval of the new drugs.
This situation, if widespread, could lead to scarcity and inequitable distribution of the drugs. Historically, as in the cases of penicillin, insulin, and other new medical developments that were initially scarce, this has led to inequitable and unjust distribution patterns.
Dr. Aronsohn and Dr. Jensen propose a needs-based solution to the dilemma. Highest priority would be given to the sickest patients, and the remaining patients could be prioritized based on need, starting with cirrhotic patients and ending with asymptomatic F0 to F2 patients. Patients could be educated about the need for providing therapy to the most ill patients and informed that waiting for therapy is safe for patients with early-stage disease.
The authors have disclosed no relevant financial relationships.
Hepatology. 2011;6:1789-1791. Abstract
Source
Also See: HCV Treaters Shortage Editorial - Distributive justice and the arrival of direct-acting antivirals: Who should be first in line?
May 27, 2011 — Earlier this month, the US Food and Drug Administration approved the drugs boceprevir (Victrelis, Merck) and telaprevir (Incivek, Vertex) for the treatment of hepatitis C virus (HCV) infection. The approvals are good news for patients with HCV, but high patient demand could lead to scarcity and ethical challenges for treatment providers, according to a viewpoint article published in the June issue of Hepatology.
HCV is responsible for 120 million infections worldwide and is a leading cause of liver failure mortality, explain authors Andrew Aronsohn, MD, and Donald Jensen, MD, from the Center for Liver Disease, Section of Gastroenterology, Hepatology, and Nutrition, University of Chicago Medical Center, Illinois. Pegylated interferon and ribavarin have had some effect, but less than half of patients with HCV achieve a sustained virologic response.
Clinical trial results suggest telaprevir and boceprevir will achieve marked improvement in sustained virologic responses in genotype 1 patients compared with current standard of care therapy.
Some patients who are at low risk for near-future progression have deferred therapy in anticipation of the arrival of these drugs. A recent Veterans' Administration study revealed that 50.3% of patients who refused treatment with interferon and ribavirin did so in anticipation of more effective drugs.
These patients will add to the demand for the drugs, complicating efforts to monitor and educate patients, which is already challenging because treatment regimens are complex. In addition, it could place undue demand on healthcare providers. The authors conducted a time analysis study at their own institution and found that the average healthcare provider could initiate treatment in 3 patients with HCV in a week. They anticipate receiving 500 new patients in the weeks after approval of the new drugs.
This situation, if widespread, could lead to scarcity and inequitable distribution of the drugs. Historically, as in the cases of penicillin, insulin, and other new medical developments that were initially scarce, this has led to inequitable and unjust distribution patterns.
Dr. Aronsohn and Dr. Jensen propose a needs-based solution to the dilemma. Highest priority would be given to the sickest patients, and the remaining patients could be prioritized based on need, starting with cirrhotic patients and ending with asymptomatic F0 to F2 patients. Patients could be educated about the need for providing therapy to the most ill patients and informed that waiting for therapy is safe for patients with early-stage disease.
The authors have disclosed no relevant financial relationships.
Hepatology. 2011;6:1789-1791. Abstract
Source
Also See: HCV Treaters Shortage Editorial - Distributive justice and the arrival of direct-acting antivirals: Who should be first in line?
All-Cause Mortality Is Higher With Chronic Hepatitis C
Megan Brooks
NEW YORK (Reuters Health) June 17, 2011 — Chronic hepatitis C doubles the normal risk of dying early from any cause, a new study shows.
That higher risk persists even after accounting for liver-related morbidity, and patients with chronic hepatitis C virus (HCV) infection should be closely monitored, the study team wrote in the June 10 online issue of Clinical Infectious Diseases.
Dr. Samer El-Kamary, who led the study, said he hopes these results "will encourage clinicians to test their patients for HCV whenever they suspect an infection, and not wait for clear signs of liver disease."
Also, he said in email to Reuters Health, "When HCV infection is diagnosed... consider earlier therapy even if there is no underlying liver disease."
Dr. El-Kamary, of the University of Maryland School of Medicine in Baltimore, and colleagues used the Third National Health and Nutrition Examination Survey (NHANES III) to analyze liver-related and non-liver-related mortality among 16,509 HCV-infected individuals, age 17 and older, in the general US population. HCV status was assessed from 1988 to 1994, with follow-up through 2006.
During a median of 14.3 years, 3,853 deaths occurred. Death rates were highest in those with chronic HCV infection and lowest in HCV-negative individuals.
For every 1000 person-years, there were 11.1 deaths in anti-HCV negative patients, compared with 14.8 and 16.5 deaths in the anti-HCV positive and chronic hepatitis C groups, respectively.
In a subset of 9,378 participants, after adjusting for all covariate risk factors, HCV-positive status was associated with a 2.11 higher all-cause mortality rate compared with HCV-negative status. Chronic HCV status was linked with a 2.37-fold higher all-cause mortality rate.
Anti-HCV positive individuals and chronically HCV-infected individuals also had a roughly 20-fold and 26-fold higher rate of liver-related mortality, respectively.
However, non–liver-related deaths were not significantly associated with HCV status, the authors found.
On the other hand, extrapolating their data to the population at large, they discovered that 57.8% of the estimated 31,163 deaths due to any cause that occur annually among the 2.46 million American adults with chronic hepatitis C are directly attributable to chronic HCV infection.
Similarly, they say 52.6% of the estimated 33,759 deaths that occur in the 3.2 million HCV-positive adults are attributable to the presence of anti-HCV.
Among the estimated 9,390 annual liver-related deaths among anti-HCV positive individuals and the 9,569 annual liver-related deaths among chronic HCV-infected individuals, 94.9% and 96.2% were attributable to HCV, respectively.
"This study suggests that mortality among HCV-infected individuals in the general US population is higher than previously described," the authors note.
"Given these findings, and the greater availability and affordability of various HCV testing methods, perhaps increased testing, earlier therapy, and closer monitoring of all HCV-positive individuals, particularly those with non-liver-related morbidities, should be considered by health care providers," they conclude.
The question is: Can anti-HCV therapy mitigate the lifespan hit imposed by HCV infection?
Dr. El-Kamary said: "We know that among those with liver disease, successful treatment definitely improves patients' survival. However, since HCV therapy is almost exclusively offered to those with liver disease, little is known about the impact on those without liver disease. We hope that this study will encourage others to evaluate the impact of treatment on HCV-infected patients without liver disease."
In May 2011, the US Food and Drug Administration approved 2 new drugs for HCV: telaprevir (Incivek, Vertex Pharmaceuticals) and boceprevir (Victrelis, Merck & Co).
At the time, Edward Cox, director of the FDA drug center's office of antimicrobial products said these two drugs present "important new treatment options for hepatitis C that offer a greater chance at a cure for some patients with this serious condition."
Clin Infect Dis. Published online June 10, 2011. Abstract
Source
NEW YORK (Reuters Health) June 17, 2011 — Chronic hepatitis C doubles the normal risk of dying early from any cause, a new study shows.
That higher risk persists even after accounting for liver-related morbidity, and patients with chronic hepatitis C virus (HCV) infection should be closely monitored, the study team wrote in the June 10 online issue of Clinical Infectious Diseases.
Dr. Samer El-Kamary, who led the study, said he hopes these results "will encourage clinicians to test their patients for HCV whenever they suspect an infection, and not wait for clear signs of liver disease."
Also, he said in email to Reuters Health, "When HCV infection is diagnosed... consider earlier therapy even if there is no underlying liver disease."
Dr. El-Kamary, of the University of Maryland School of Medicine in Baltimore, and colleagues used the Third National Health and Nutrition Examination Survey (NHANES III) to analyze liver-related and non-liver-related mortality among 16,509 HCV-infected individuals, age 17 and older, in the general US population. HCV status was assessed from 1988 to 1994, with follow-up through 2006.
During a median of 14.3 years, 3,853 deaths occurred. Death rates were highest in those with chronic HCV infection and lowest in HCV-negative individuals.
For every 1000 person-years, there were 11.1 deaths in anti-HCV negative patients, compared with 14.8 and 16.5 deaths in the anti-HCV positive and chronic hepatitis C groups, respectively.
In a subset of 9,378 participants, after adjusting for all covariate risk factors, HCV-positive status was associated with a 2.11 higher all-cause mortality rate compared with HCV-negative status. Chronic HCV status was linked with a 2.37-fold higher all-cause mortality rate.
Anti-HCV positive individuals and chronically HCV-infected individuals also had a roughly 20-fold and 26-fold higher rate of liver-related mortality, respectively.
However, non–liver-related deaths were not significantly associated with HCV status, the authors found.
On the other hand, extrapolating their data to the population at large, they discovered that 57.8% of the estimated 31,163 deaths due to any cause that occur annually among the 2.46 million American adults with chronic hepatitis C are directly attributable to chronic HCV infection.
Similarly, they say 52.6% of the estimated 33,759 deaths that occur in the 3.2 million HCV-positive adults are attributable to the presence of anti-HCV.
Among the estimated 9,390 annual liver-related deaths among anti-HCV positive individuals and the 9,569 annual liver-related deaths among chronic HCV-infected individuals, 94.9% and 96.2% were attributable to HCV, respectively.
"This study suggests that mortality among HCV-infected individuals in the general US population is higher than previously described," the authors note.
"Given these findings, and the greater availability and affordability of various HCV testing methods, perhaps increased testing, earlier therapy, and closer monitoring of all HCV-positive individuals, particularly those with non-liver-related morbidities, should be considered by health care providers," they conclude.
The question is: Can anti-HCV therapy mitigate the lifespan hit imposed by HCV infection?
Dr. El-Kamary said: "We know that among those with liver disease, successful treatment definitely improves patients' survival. However, since HCV therapy is almost exclusively offered to those with liver disease, little is known about the impact on those without liver disease. We hope that this study will encourage others to evaluate the impact of treatment on HCV-infected patients without liver disease."
In May 2011, the US Food and Drug Administration approved 2 new drugs for HCV: telaprevir (Incivek, Vertex Pharmaceuticals) and boceprevir (Victrelis, Merck & Co).
At the time, Edward Cox, director of the FDA drug center's office of antimicrobial products said these two drugs present "important new treatment options for hepatitis C that offer a greater chance at a cure for some patients with this serious condition."
Clin Infect Dis. Published online June 10, 2011. Abstract
Source
BioPlus' Hepatitis C Patient Support Program Improves Treatment Outcomes of New Triple Therapy
06/20/11
HepatitisRxAssist program from BioPlus Specialty Pharmacy helps patients secure needed medications, manage side effects, and adhere to their treatment plan for the best possible outcomes with the new protease inhibitor medications.
BioPlus Specialty Pharmacy (BioPlus), one of the nation's leading specialty pharmacies, is announcing today enhancements to their hepatitis C patient support program called HepatitisRxAssist. The FDA's recent approval of two new drugs for the treatment of the hepatitis C virus (HCV) – Victrelis (boceprevir) from Merck and Incivek (telaprevir) from Vertex – makes this program more useful than ever for hepatitis C patients.
Victrelis and Incivek are both protease inhibitors and have each been shown to greatly increase the viral cure rate in HCV when given in addition to standard hepatitis C treatments. Each of these protease inhibitors can only be used as part of a three drug combination (along with peginterferon alpha and ribavirin), and not as a single drug treatment.
The overriding goal of the HepatitisRxAssist program is to ensure treatment and improve outcomes. BioPlus tracks compliance statistics for all its treatment programs. The latest data, which includes more than 19,700 BioPlus patients being treated for HCV, oncology, rheumatoid arthritis, psoriasis, Crohn's disease, and other conditions, shows that BioPlus achieves a 91 percent compliance rate at discharge. The compliance rate for retail and mail-order pharmacies is only 50 percent.
The HepatitisRxAssist program supports physicians by providing administrative help in handling the complex paperwork for starting triple therapy. The new hepatitis triple therapy can be challenging for patients for several reasons, including the high cost of treatment, multiple pills needed each day on a strict schedule, injection training, and the high likelihood of side effects. The intensive monitoring for safety and efficacy by a specialized clinical pharmacist and support staff in the HepatitisRxAssist program helps patients successfully address each of these treatment hurdles.
“These two new protease inhibitors, while signifying a new era of treatment, also present new treatment challenges. Here at BioPlus, we work with HCV patients in every step of navigating these challenges so that the potential for greater cure rates is realized for as many patients as possible,” says Dr. Stephen Vogt, president and CEO of BioPlus.
The HepatitisRxAssist program encompasses a team of BioPlus professionals that work on behalf of the patient to review the insurance benefit plan, get authorizations, identify alternative financial aid (if necessary), provide home delivery of medications, assist with the management of side effects, and provide 24/7 phone access to pharmacists including nights, weekends, and holidays.
This high touch, patient-centric support program also includes these key features:
• An initial consult with a Doctor of Pharmacy for every patient starting the new triple therapy. This 30 minute consult includes an assessment of the patient, education for the patient about the medication protocol, and detailed explanation of the plan of care to ultimately provide the best possible care with our experienced clinicians.
• Hands-on injection training with a nurse either in the patient's home or in a group setting so that patients feel comfortable and confident administering their own medication injections.
• On the day medications are started, BioPlus staff will check on the patient to provide a dose reminder, as well as answer any questions or clarify the medication schedule to ensure the patients are properly starting their treatment.
• This patient contact will be repeated weekly for the first four weeks of medication therapy and continued, if needed, to ensure the patients are staying compliant throughout their course of therapy and ultimately achieve successful outcomes.
• A dose reminder system using texts, e-mail, or phone calls to further assist the patients in staying compliant to their therapy.
• The patient's physician can review all of this information about the patient from a portal on the BioPlus website in order to keep our prescribers updated on the status of their patients.
“With the availability of this new triple therapy regimen, backed by our support program, we're expecting significant gains in the number of patients clearing the virus to obtain a sustained viral response and, as an added benefit, patients may even have shorter treatment times,” Dr. Vogt adds.
Hepatitis C is the most common chronic blood-borne disease in the United States. This virus attaches to liver cells, where it then multiplies to cause inflammation and a shutdown of normal liver cell functions. For the majority of people infected with HCV, the disease becomes a chronic condition and can lead to co-morbidities, such as cirrhosis or cancer.
About BioPlus Specialty Pharmacy
Florida-based BioPlus is a pharmacist-owned national specialty infusion pharmacy company designed to provide high-touch services and specialty pharmaceuticals for patients with chronic diseases such as arthritis, hepatitis C, cancer, and others. Licensed in all 50 states, BioPlus is one of the nation's largest independent specialty pharmacies. Accredited by the Community Health Accreditation Program (CHAP), patients can contact the Pharmacy toll free at 1-888-292-0744.
Source
HepatitisRxAssist program from BioPlus Specialty Pharmacy helps patients secure needed medications, manage side effects, and adhere to their treatment plan for the best possible outcomes with the new protease inhibitor medications.
BioPlus Specialty Pharmacy (BioPlus), one of the nation's leading specialty pharmacies, is announcing today enhancements to their hepatitis C patient support program called HepatitisRxAssist. The FDA's recent approval of two new drugs for the treatment of the hepatitis C virus (HCV) – Victrelis (boceprevir) from Merck and Incivek (telaprevir) from Vertex – makes this program more useful than ever for hepatitis C patients.
Victrelis and Incivek are both protease inhibitors and have each been shown to greatly increase the viral cure rate in HCV when given in addition to standard hepatitis C treatments. Each of these protease inhibitors can only be used as part of a three drug combination (along with peginterferon alpha and ribavirin), and not as a single drug treatment.
The overriding goal of the HepatitisRxAssist program is to ensure treatment and improve outcomes. BioPlus tracks compliance statistics for all its treatment programs. The latest data, which includes more than 19,700 BioPlus patients being treated for HCV, oncology, rheumatoid arthritis, psoriasis, Crohn's disease, and other conditions, shows that BioPlus achieves a 91 percent compliance rate at discharge. The compliance rate for retail and mail-order pharmacies is only 50 percent.
The HepatitisRxAssist program supports physicians by providing administrative help in handling the complex paperwork for starting triple therapy. The new hepatitis triple therapy can be challenging for patients for several reasons, including the high cost of treatment, multiple pills needed each day on a strict schedule, injection training, and the high likelihood of side effects. The intensive monitoring for safety and efficacy by a specialized clinical pharmacist and support staff in the HepatitisRxAssist program helps patients successfully address each of these treatment hurdles.
“These two new protease inhibitors, while signifying a new era of treatment, also present new treatment challenges. Here at BioPlus, we work with HCV patients in every step of navigating these challenges so that the potential for greater cure rates is realized for as many patients as possible,” says Dr. Stephen Vogt, president and CEO of BioPlus.
The HepatitisRxAssist program encompasses a team of BioPlus professionals that work on behalf of the patient to review the insurance benefit plan, get authorizations, identify alternative financial aid (if necessary), provide home delivery of medications, assist with the management of side effects, and provide 24/7 phone access to pharmacists including nights, weekends, and holidays.
This high touch, patient-centric support program also includes these key features:
• An initial consult with a Doctor of Pharmacy for every patient starting the new triple therapy. This 30 minute consult includes an assessment of the patient, education for the patient about the medication protocol, and detailed explanation of the plan of care to ultimately provide the best possible care with our experienced clinicians.
• Hands-on injection training with a nurse either in the patient's home or in a group setting so that patients feel comfortable and confident administering their own medication injections.
• On the day medications are started, BioPlus staff will check on the patient to provide a dose reminder, as well as answer any questions or clarify the medication schedule to ensure the patients are properly starting their treatment.
• This patient contact will be repeated weekly for the first four weeks of medication therapy and continued, if needed, to ensure the patients are staying compliant throughout their course of therapy and ultimately achieve successful outcomes.
• A dose reminder system using texts, e-mail, or phone calls to further assist the patients in staying compliant to their therapy.
• The patient's physician can review all of this information about the patient from a portal on the BioPlus website in order to keep our prescribers updated on the status of their patients.
“With the availability of this new triple therapy regimen, backed by our support program, we're expecting significant gains in the number of patients clearing the virus to obtain a sustained viral response and, as an added benefit, patients may even have shorter treatment times,” Dr. Vogt adds.
Hepatitis C is the most common chronic blood-borne disease in the United States. This virus attaches to liver cells, where it then multiplies to cause inflammation and a shutdown of normal liver cell functions. For the majority of people infected with HCV, the disease becomes a chronic condition and can lead to co-morbidities, such as cirrhosis or cancer.
About BioPlus Specialty Pharmacy
Florida-based BioPlus is a pharmacist-owned national specialty infusion pharmacy company designed to provide high-touch services and specialty pharmaceuticals for patients with chronic diseases such as arthritis, hepatitis C, cancer, and others. Licensed in all 50 states, BioPlus is one of the nation's largest independent specialty pharmacies. Accredited by the Community Health Accreditation Program (CHAP), patients can contact the Pharmacy toll free at 1-888-292-0744.
Source
Directly acting antivirals against hepatitis C virus
J Antimicrob Chemother. 2011 Jun 7. [Epub ahead of print]
Soriano V, Vispo E, Poveda E, Labarga P, Martin-Carbonero L, Fernandez-Montero JV, Barreiro P.
Department of Infectious Diseases, Hospital Carlos III, Madrid, Spain.
Abstract
The approval of directly acting antivirals (DAA) for the treatment of chronic hepatitis C virus (HCV) infection will represent a major breakthrough for the 180 million persons infected worldwide. Paradoxically, hepatitis C is the only human chronic viral disease that can be cured, as all other pathogenic viruses infecting humans either display self-limited courses or establish non-eradicable persistent infections. Until now, treatment of chronic hepatitis C consisted of the combination of peginterferon-α plus ribavirin, which provided limited rates of cure and was associated with frequent side effects. Several DAA have been identified that inhibit the NS3 protease, the NS5B polymerase or the NS5A replication complex, and have entered the final steps of clinical development. These molecules, coupled with significant progress made in the recognition of more potent and safe interferon forms (e.g. interferon-λ) and host protein targets (e.g. alisporivir), are opening a new era in hepatitis C therapeutics. The expectations are so great that, to some extent, it is reminiscent of what happened in 1996 in the HIV field when the introduction of the first protease inhibitors as part of triple combinations revolutionized antiretroviral therapy. To maximize treatment success and reduce the likelihood of drug resistance selection, a proper individualization of hepatitis C therapy will be required, choosing the most convenient drugs and strategies according to distinct viral and host profiles. The complexity of HCV therapeutics has reached a point that presumably will lead to the birth of a new specialist, the HCV doctor.
Source
Soriano V, Vispo E, Poveda E, Labarga P, Martin-Carbonero L, Fernandez-Montero JV, Barreiro P.
Department of Infectious Diseases, Hospital Carlos III, Madrid, Spain.
Abstract
The approval of directly acting antivirals (DAA) for the treatment of chronic hepatitis C virus (HCV) infection will represent a major breakthrough for the 180 million persons infected worldwide. Paradoxically, hepatitis C is the only human chronic viral disease that can be cured, as all other pathogenic viruses infecting humans either display self-limited courses or establish non-eradicable persistent infections. Until now, treatment of chronic hepatitis C consisted of the combination of peginterferon-α plus ribavirin, which provided limited rates of cure and was associated with frequent side effects. Several DAA have been identified that inhibit the NS3 protease, the NS5B polymerase or the NS5A replication complex, and have entered the final steps of clinical development. These molecules, coupled with significant progress made in the recognition of more potent and safe interferon forms (e.g. interferon-λ) and host protein targets (e.g. alisporivir), are opening a new era in hepatitis C therapeutics. The expectations are so great that, to some extent, it is reminiscent of what happened in 1996 in the HIV field when the introduction of the first protease inhibitors as part of triple combinations revolutionized antiretroviral therapy. To maximize treatment success and reduce the likelihood of drug resistance selection, a proper individualization of hepatitis C therapy will be required, choosing the most convenient drugs and strategies according to distinct viral and host profiles. The complexity of HCV therapeutics has reached a point that presumably will lead to the birth of a new specialist, the HCV doctor.
Source
Public Supports Universal Hepatitis C Screening
Jim Kling
June 20, 2011 — A new study indicates that patients support universal screening for hepatitis C virus (HCV) infection, even in the absence of prior consent or communication of negative results. The study was published online June 6 in BMC Infectious Diseases.
Between 2.9 and 3.7 million people in the United States are infected with HCV, and about 70% are unaware of it. Between 20% and 30% of the infected patients will go on to develop cirrhosis. HCV is the most common cause of liver failure among liver transplant patients.
Current therapies achieve about a 50% cure rate, and broad implementation could reduce HCV complications by 16% to 42%.
Current screening guidelines direct physicians to screen patients when they have one or more risk factors, such as injected drug use, having received a blood transfusion before 1992, or elevated liver function tests. However, such screening is complicated because patients may not admit to past behaviors such as drug abuse, among other limitations, including not capturing other potential risk factors such as possible remote iatrogenic transmission.
To gauge the public's opinion on potential HCV screening programs, in August 2010 the researchers, led by Phillip O. Coffin, MD, MIA, from the Division of Allergy and Infectious Diseases, University of Washington, Seattle, conducted a survey at 5 outpatient clinics of a major public urban medical center in Seattle. The response rate was 85.8% (200 responses of 233 patients surveyed). The study group had a median age of 47 years and included 55.3% women. Of the participants, 56.3% were white, 32.7% were black, 9.5% said they had been tested positive for HCV, and 2.5% reported testing positive for HIV.
The survey included 3 options: universal testing without being informed of the test or being told of negative results (48% preferred this option); testing with an opportunity to opt out, and without being informed of negative results (37% preferred); and testing based on clinician judgment (15% preferred).
Limitations of the study include the lack of both generalizability and disease confirmation status reported by the participants. In addition, the respondents were not asked all of the same questions, which limited comparisons. This was also a quantitative, not qualitative, analysis, which may alter results.
"[P]atients appear to place a higher priority on being tested than they do on the process of informed consent or the receipt of negative results. These findings should inform the priorities of clinicians, public health officials, and clinical risk managers," the authors conclude.
Dr. Coffin’s work is supported by a grant from the National Institute of Allergy and Infectious Diseases. The authors have disclosed no relevant financial relationships.
BMC Infect Dis. Published online June 6, 2011. Full text
Source
June 20, 2011 — A new study indicates that patients support universal screening for hepatitis C virus (HCV) infection, even in the absence of prior consent or communication of negative results. The study was published online June 6 in BMC Infectious Diseases.
Between 2.9 and 3.7 million people in the United States are infected with HCV, and about 70% are unaware of it. Between 20% and 30% of the infected patients will go on to develop cirrhosis. HCV is the most common cause of liver failure among liver transplant patients.
Current therapies achieve about a 50% cure rate, and broad implementation could reduce HCV complications by 16% to 42%.
Current screening guidelines direct physicians to screen patients when they have one or more risk factors, such as injected drug use, having received a blood transfusion before 1992, or elevated liver function tests. However, such screening is complicated because patients may not admit to past behaviors such as drug abuse, among other limitations, including not capturing other potential risk factors such as possible remote iatrogenic transmission.
To gauge the public's opinion on potential HCV screening programs, in August 2010 the researchers, led by Phillip O. Coffin, MD, MIA, from the Division of Allergy and Infectious Diseases, University of Washington, Seattle, conducted a survey at 5 outpatient clinics of a major public urban medical center in Seattle. The response rate was 85.8% (200 responses of 233 patients surveyed). The study group had a median age of 47 years and included 55.3% women. Of the participants, 56.3% were white, 32.7% were black, 9.5% said they had been tested positive for HCV, and 2.5% reported testing positive for HIV.
The survey included 3 options: universal testing without being informed of the test or being told of negative results (48% preferred this option); testing with an opportunity to opt out, and without being informed of negative results (37% preferred); and testing based on clinician judgment (15% preferred).
Limitations of the study include the lack of both generalizability and disease confirmation status reported by the participants. In addition, the respondents were not asked all of the same questions, which limited comparisons. This was also a quantitative, not qualitative, analysis, which may alter results.
"[P]atients appear to place a higher priority on being tested than they do on the process of informed consent or the receipt of negative results. These findings should inform the priorities of clinicians, public health officials, and clinical risk managers," the authors conclude.
Dr. Coffin’s work is supported by a grant from the National Institute of Allergy and Infectious Diseases. The authors have disclosed no relevant financial relationships.
BMC Infect Dis. Published online June 6, 2011. Full text
Source
How the Immune System Responds to Hepatitis A Virus
ScienceDaily (June 21, 2011) — A surprising finding in a study comparing hepatitis C virus (HCV) with hepatitis A virus (HAV) infections in chimpanzees by a team that includes scientists from the Texas Biomedical Research Institute sheds new light on the nature of the body's immune response to these viruses.
Understanding how hepatitis C becomes chronic is very important because some 200 million people worldwide and 3.2 million people in the U.S. are chronically infected with HCV and are at risk for progression to cirrhosis and liver cancer. Hepatitis C associated liver disease is the most common indication for liver transplantation, while liver cancer due to HCV infection is now the most rapidly increasing cause of cancer death in the U.S.
"Remarkably, we found that HAV was more adept at evading the innate immune response than HCV, the virus that ultimately causes chronic infections," said Robert E. Lanford, Ph.D., a Texas Biomed virologist. The novel findings demonstrate that HAV is the stealthier virus when it comes to evading the innate immune response, despite the lack of persistent infections.
Hepatitis C infections are characterized by a failure of the immune system to combat and eliminate the virus. "We suspect this failure of the immune system shares attributes with other persistent viruses such as HIV and hepatitis B virus," said Lanford. By comparing two similar viruses that infect the liver, one that is always cleared by the immune system, HAV, and one that frequently evades the immune response, HCV, the team hoped to unravel the mystery of how HCV causes lifelong persistent infections.
The research team involved scientists from Texas Biomed in San Antonio, the University of North Carolina (UNC) at Chapel Hill, and Nationwide Children's Hospital in Columbus, Ohio. The study performed in chimpanzees at Texas Biomed's Southwest National Primate Research Center (SNPRC) and funded by the National Institutes of Health, is published June 20 in Proceedings of the National Academy of Sciences U.S.A.
The new study points out the critical need for more information about how the immune system reacts to HCV. It also reinforces the importance of chimpanzee research in this effort. The chimpanzee, the only animal model susceptible to HCV infection, was critical for probing the molecular differences in gene expression in the liver related to infection by the two viruses.
Examination of the adaptive immune system by co-author Christopher M. Walker, Ph.D., of Nationwide Children's Hospital in Columbus, Ohio, found that the T cell response to HAV was unique as well. "We expected the immune response to kill all HAV infected cells in a short time frame, and yet we could detect the genome of the virus in the liver for up to one year, long after symptoms of the disease were resolved," Lanford explained.
"Hepatitis viruses have co-evolved with humans over a very long period of time and they are good at evading the immune system, but nobody understands how hepatitis C becomes a chronic infection," said co-author Stanley M. Lemon, M.D., of UNC.
"The surprising and exciting results of this research program further highlight the critical value of the chimpanzee model in research on hepatitis," said John L. VandeBerg, Ph.D., Texas Biomed's chief scientific officer and SNPRC director
Others on the study included Deborah Chavez, M.S., and Bernadette Guerra, B.S., of Texas Biomed; Kathleen Brasky, D.V.M, of SNPRC; Zongdi Feng, Ph.D., and Daisuke Yamane, D.V.M, Ph.D., of UNC; Yan Zhou, Ph.D., Nationwide Children's Hospital; and Alan S. Perelson, Ph.D., of the Los Alamos National Laboratory.
Journal Reference:
1. Robert E. Lanford, Zongdi Feng, Deborah Chavez, Bernadette Guerra, Kathleen M. Brasky, Yan Zhou, Daisuke Yamane, Alan S. Perelson, Christopher M. Walker, and Stanley M. Lemon. Acute hepatitis A virus infection is associated with a limited type I interferon response and persistence of intrahepatic viral RNA. PNAS, June 20, 2011 DOI: 10.1073/pnas.1101939108
Source
Also See: Acute Hepatitis A Evades Immune System More Effectively Than Chronic Cousin
Understanding how hepatitis C becomes chronic is very important because some 200 million people worldwide and 3.2 million people in the U.S. are chronically infected with HCV and are at risk for progression to cirrhosis and liver cancer. Hepatitis C associated liver disease is the most common indication for liver transplantation, while liver cancer due to HCV infection is now the most rapidly increasing cause of cancer death in the U.S.
"Remarkably, we found that HAV was more adept at evading the innate immune response than HCV, the virus that ultimately causes chronic infections," said Robert E. Lanford, Ph.D., a Texas Biomed virologist. The novel findings demonstrate that HAV is the stealthier virus when it comes to evading the innate immune response, despite the lack of persistent infections.
Hepatitis C infections are characterized by a failure of the immune system to combat and eliminate the virus. "We suspect this failure of the immune system shares attributes with other persistent viruses such as HIV and hepatitis B virus," said Lanford. By comparing two similar viruses that infect the liver, one that is always cleared by the immune system, HAV, and one that frequently evades the immune response, HCV, the team hoped to unravel the mystery of how HCV causes lifelong persistent infections.
The research team involved scientists from Texas Biomed in San Antonio, the University of North Carolina (UNC) at Chapel Hill, and Nationwide Children's Hospital in Columbus, Ohio. The study performed in chimpanzees at Texas Biomed's Southwest National Primate Research Center (SNPRC) and funded by the National Institutes of Health, is published June 20 in Proceedings of the National Academy of Sciences U.S.A.
The new study points out the critical need for more information about how the immune system reacts to HCV. It also reinforces the importance of chimpanzee research in this effort. The chimpanzee, the only animal model susceptible to HCV infection, was critical for probing the molecular differences in gene expression in the liver related to infection by the two viruses.
Examination of the adaptive immune system by co-author Christopher M. Walker, Ph.D., of Nationwide Children's Hospital in Columbus, Ohio, found that the T cell response to HAV was unique as well. "We expected the immune response to kill all HAV infected cells in a short time frame, and yet we could detect the genome of the virus in the liver for up to one year, long after symptoms of the disease were resolved," Lanford explained.
"Hepatitis viruses have co-evolved with humans over a very long period of time and they are good at evading the immune system, but nobody understands how hepatitis C becomes a chronic infection," said co-author Stanley M. Lemon, M.D., of UNC.
"The surprising and exciting results of this research program further highlight the critical value of the chimpanzee model in research on hepatitis," said John L. VandeBerg, Ph.D., Texas Biomed's chief scientific officer and SNPRC director
Others on the study included Deborah Chavez, M.S., and Bernadette Guerra, B.S., of Texas Biomed; Kathleen Brasky, D.V.M, of SNPRC; Zongdi Feng, Ph.D., and Daisuke Yamane, D.V.M, Ph.D., of UNC; Yan Zhou, Ph.D., Nationwide Children's Hospital; and Alan S. Perelson, Ph.D., of the Los Alamos National Laboratory.
Journal Reference:
1. Robert E. Lanford, Zongdi Feng, Deborah Chavez, Bernadette Guerra, Kathleen M. Brasky, Yan Zhou, Daisuke Yamane, Alan S. Perelson, Christopher M. Walker, and Stanley M. Lemon. Acute hepatitis A virus infection is associated with a limited type I interferon response and persistence of intrahepatic viral RNA. PNAS, June 20, 2011 DOI: 10.1073/pnas.1101939108
Source
Also See: Acute Hepatitis A Evades Immune System More Effectively Than Chronic Cousin
Legendary Musician Gregg Allman Joins Merck and American Liver Foundation to Launch Tune In to Hep C Public Awareness Campaign
Benefit Concert to be Held in New York on July 27, the Eve of World Hepatitis Day
WHITEHOUSE STATION, N.J., June 21, 2011 /PRNewswire/ -- Merck (NYSE: MRK) (known as MSD outside the United States and Canada) today announced that Rock 'n Roll Hall of Famer Gregg Allman will work together with the company and the American Liver Foundation on Tune In to Hep C, a public health campaign to help raise awareness of chronic hepatitis C virus infection. To help turn up the volume around hepatitis C a benefit concert featuring The Allman Brothers Band will be held in New York on July 27, the eve of World Hepatitis Day.
This week marks the one-year anniversary of Allman's liver transplant, which he received after his liver had become damaged from chronic hepatitis C infection. Allman has returned to performing and recording music, and now wants to help raise awareness of hepatitis C.
"I'm excited to be working with Merck and the American Liver Foundation because there are many people who have been diagnosed with chronic hepatitis C, but aren't taking action. I want to tell them, don't wait. Doing nothing is not an option; they need to talk with their doctor," said Allman, a founding member of The Allman Brothers Band. "I made the decision to take action and talk to my doctor, so that I could get back to making the music I love. I want others to take that action too, and if I can help make that happen, I've done my job."
Nearly 3.2 million Americans have chronic hepatitis C virus infection, a potentially serious disease that can damage the liver over time and lead to cirrhosis, end-stage liver disease and liver cancer. Many people infected with chronic hepatitis C do not know that they have the virus – approximately 60 to 80 percent of people infected with chronic hepatitis C virus do not have symptoms.
The American Liver Foundation (ALF) joined the Tune In to Hep C campaign to help elevate awareness of this important public health issue. ALF is a national organization advocating for those living with liver disease and their families, and provides education, support and research for the prevention, treatment and cure of liver disease.
"We are thrilled to work with Merck and Gregg Allman to help educate and empower patients with chronic hepatitis C – this has been a focus of the American Liver Foundation for 35 years," said Newton Guerin, acting CEO and chief operating officer, ALF. "People don't often talk openly about their hepatitis C, which contributes to misinformation and isolation for those infected with the virus. Gregg's willingness to share his story will open the door for meaningful dialogue that can help reduce stigma and the lack of understanding surrounding chronic hepatitis C."
Merck recently announced the Hope Against Hepatitis C initiative, in which the company restated its long-standing commitment to supporting the hepatitis C community through a variety of public-private partnerships that will involve public education, patient support programs and collaborative research efforts. Working with Gregg Allman and the ALF is an example of this ongoing commitment.
"When a person like Gregg Allman comes forward to speak about his personal experience, it is extremely powerful, and we are grateful to him for his commitment to helping motivate other people with chronic hepatitis C to take action," said Mark Timney, president, Global Human Health - U.S. Market, Merck.
About the Benefit Concert
The concert, Tune In to Hep C Presents The Allman Brothers Band, will take place at The Beacon Theatre in New York City on July 27, the eve of World Hepatitis Day. The Beacon Theatre has special meaning for Allman, who has played there every year since 1991 with the exception of 2007, when the band had to cancel their performance because Allman was too ill from his chronic hepatitis C to play. Tickets will go on sale tomorrow, Wednesday, June 22 at 12:00PM EDT. Tickets are available at LiveNation.com, Ticketmaster.com, select Ticketmaster locations and charge by phone at 800-745-3000. Tickets also will be available at The Beacon Theatre box office beginning June 23.
Proceeds from the benefit concert will be donated to community-based organizations that provide education and support services to people with chronic hepatitis C.
About Gregg Allman
Allman is a legendary performer who is both a founding member of The Allman Brothers Band and a critically acclaimed solo artist. He has several gold records to his credit and his distinctive voice placed him on the Rolling Stone list of the "100 Greatest Singers of All Time." More than 40 years down the road, Allman still loves making and performing music as much as ever.
In addition to his singing and playing, Allman wrote many of The Allman Brothers Band's most memorable signature hits, including the classics "Whipping Post" and "Dreams" from their self-titled debut album, "Midnight Rider" and "Please Call Home" from their second album "Idlewild South," and "Melissa" from 1972's classic "Eat A Peach" album. The Allman Brothers Band went on to become the principal architects of Southern rock and were inducted into the Rock 'n Roll Hall of Fame in 1995. Allman's latest solo album "Low Country Blues" was released in 2011, debuting at No. 5 on the Billboard Top 200, the highest chart position of his solo career, and continues to gain critical acclaim and commercial success.
About The American Liver Foundation
The American Liver Foundation (ALF) is the nation's leading nonprofit organization promoting liver health and disease prevention. ALF provides research, education and advocacy for those affected by liver-related diseases, including hepatitis.
About Merck
Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit http://www.merck.com/.
Forward-Looking Statement
This news release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined company's plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck's management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.
The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period; the impact of pharmaceutical industry regulation and health care legislation; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; Merck's ability to accurately predict future market conditions; dependence on the effectiveness of Merck's patents and other protections for innovative products; the risk of new and changing regulation and health policies in the United States and internationally and the exposure to litigation and/or regulatory actions.
Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck's 2010 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (http://www.sec.gov/).
SOURCE Merck
RELATED LINKS
http://www.merck.com/
Source
WHITEHOUSE STATION, N.J., June 21, 2011 /PRNewswire/ -- Merck (NYSE: MRK) (known as MSD outside the United States and Canada) today announced that Rock 'n Roll Hall of Famer Gregg Allman will work together with the company and the American Liver Foundation on Tune In to Hep C, a public health campaign to help raise awareness of chronic hepatitis C virus infection. To help turn up the volume around hepatitis C a benefit concert featuring The Allman Brothers Band will be held in New York on July 27, the eve of World Hepatitis Day.
This week marks the one-year anniversary of Allman's liver transplant, which he received after his liver had become damaged from chronic hepatitis C infection. Allman has returned to performing and recording music, and now wants to help raise awareness of hepatitis C.
"I'm excited to be working with Merck and the American Liver Foundation because there are many people who have been diagnosed with chronic hepatitis C, but aren't taking action. I want to tell them, don't wait. Doing nothing is not an option; they need to talk with their doctor," said Allman, a founding member of The Allman Brothers Band. "I made the decision to take action and talk to my doctor, so that I could get back to making the music I love. I want others to take that action too, and if I can help make that happen, I've done my job."
Nearly 3.2 million Americans have chronic hepatitis C virus infection, a potentially serious disease that can damage the liver over time and lead to cirrhosis, end-stage liver disease and liver cancer. Many people infected with chronic hepatitis C do not know that they have the virus – approximately 60 to 80 percent of people infected with chronic hepatitis C virus do not have symptoms.
The American Liver Foundation (ALF) joined the Tune In to Hep C campaign to help elevate awareness of this important public health issue. ALF is a national organization advocating for those living with liver disease and their families, and provides education, support and research for the prevention, treatment and cure of liver disease.
"We are thrilled to work with Merck and Gregg Allman to help educate and empower patients with chronic hepatitis C – this has been a focus of the American Liver Foundation for 35 years," said Newton Guerin, acting CEO and chief operating officer, ALF. "People don't often talk openly about their hepatitis C, which contributes to misinformation and isolation for those infected with the virus. Gregg's willingness to share his story will open the door for meaningful dialogue that can help reduce stigma and the lack of understanding surrounding chronic hepatitis C."
Merck recently announced the Hope Against Hepatitis C initiative, in which the company restated its long-standing commitment to supporting the hepatitis C community through a variety of public-private partnerships that will involve public education, patient support programs and collaborative research efforts. Working with Gregg Allman and the ALF is an example of this ongoing commitment.
"When a person like Gregg Allman comes forward to speak about his personal experience, it is extremely powerful, and we are grateful to him for his commitment to helping motivate other people with chronic hepatitis C to take action," said Mark Timney, president, Global Human Health - U.S. Market, Merck.
About the Benefit Concert
The concert, Tune In to Hep C Presents The Allman Brothers Band, will take place at The Beacon Theatre in New York City on July 27, the eve of World Hepatitis Day. The Beacon Theatre has special meaning for Allman, who has played there every year since 1991 with the exception of 2007, when the band had to cancel their performance because Allman was too ill from his chronic hepatitis C to play. Tickets will go on sale tomorrow, Wednesday, June 22 at 12:00PM EDT. Tickets are available at LiveNation.com, Ticketmaster.com, select Ticketmaster locations and charge by phone at 800-745-3000. Tickets also will be available at The Beacon Theatre box office beginning June 23.
Proceeds from the benefit concert will be donated to community-based organizations that provide education and support services to people with chronic hepatitis C.
About Gregg Allman
Allman is a legendary performer who is both a founding member of The Allman Brothers Band and a critically acclaimed solo artist. He has several gold records to his credit and his distinctive voice placed him on the Rolling Stone list of the "100 Greatest Singers of All Time." More than 40 years down the road, Allman still loves making and performing music as much as ever.
In addition to his singing and playing, Allman wrote many of The Allman Brothers Band's most memorable signature hits, including the classics "Whipping Post" and "Dreams" from their self-titled debut album, "Midnight Rider" and "Please Call Home" from their second album "Idlewild South," and "Melissa" from 1972's classic "Eat A Peach" album. The Allman Brothers Band went on to become the principal architects of Southern rock and were inducted into the Rock 'n Roll Hall of Fame in 1995. Allman's latest solo album "Low Country Blues" was released in 2011, debuting at No. 5 on the Billboard Top 200, the highest chart position of his solo career, and continues to gain critical acclaim and commercial success.
About The American Liver Foundation
The American Liver Foundation (ALF) is the nation's leading nonprofit organization promoting liver health and disease prevention. ALF provides research, education and advocacy for those affected by liver-related diseases, including hepatitis.
About Merck
Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit http://www.merck.com/.
Forward-Looking Statement
This news release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined company's plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck's management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.
The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period; the impact of pharmaceutical industry regulation and health care legislation; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; Merck's ability to accurately predict future market conditions; dependence on the effectiveness of Merck's patents and other protections for innovative products; the risk of new and changing regulation and health policies in the United States and internationally and the exposure to litigation and/or regulatory actions.
Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck's 2010 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (http://www.sec.gov/).
SOURCE Merck
RELATED LINKS
http://www.merck.com/
Source
Acute Hepatitis A Evades Immune System More Effectively Than Chronic Cousin
ScienceDaily (June 20, 2011) — Ongoing research into the problem of how Hepatitis C becomes a chronic disease has uncovered a deeper mystery about its sister strain, Hepatitis A.
Hepatitis C is a continuing public health problem, which is difficult to measure because symptoms occur months to years after infection. The World Health Organization estimates as many as 2 to 4 million people in the United States may have chronic Hepatitis C, and most do not know they are infected. More than a third of those who are long-term carriers may develop chronic liver disease or liver cancer.
"Hepatitis viruses have co-evolved with humans over a very long period of time and they are good at evading the immune system, but nobody understands how Hepatitis C becomes a chronic infection," says Stanley M. Lemon, MD, professor of microbiology and immunology and a member of UNC Lineberger Comprehensive Cancer Center and the Center for Translational Immunology.
Lemon and his colleagues thought that Hepatitis C might become chronic by disrupting the host's interferon response -- part of the innate immune system that protects the body against any kind of 'foreign' invader.
However, their study, published on-line in the Early Edition of the journal Proceedings of the National Academy of Sciences U.S.A., came up with some surprising findings.
In comparing data from experiments with Hepatitis A and Hepatitis C, the team found that Hepatitis A virus, which causes only acute, self-limited disease, is more efficient at inhibiting the host's interferon response, and that the virus can actually linger in the body for almost a year.
"These results undermine the theory that evasion of the interferon response is a key mechanism in the development of chronic Hepatitis C -- the outcome of infection with these viruses is very different, highlighting how little we understand the unique environment within the liver for virus-host interactions," Lemon notes.
"It is actually the acute infection, Hepatitis A, that is stealthier at evading the interferon response."
In addition to Lemon, the research team included Zongdi Feng, Ph.D., and Daisuke Yamane, D.V.M, Ph.D. from UNC-Chapel Hill; Robert Lanford, PhD, of the Texas Biomedical Research Institute and the Southwest National Primate Research Center; Deborah Chavez, MS, and Bernadette Guerra, BS, from the Texas Biomedical Research Institute; Kathleen Brasky, DVM, of the Southwest National Primate Center; Yan Zhou, PhD, and Christopher Walker, PhD, of the Center for Vaccines and Immunity at Nationwide Children's Hospital in Columbus, OH; and Alan Perelson, PhD, from Los Alamos National Laboratory.
The research was funded by the National Institutes of Health.
Journal Reference:
1. Robert E. Lanford, Zongdi Feng, Deborah Chavez, Bernadette Guerra, Kathleen M. Brasky, Yan Zhou, Daisuke Yamane, Alan S. Perelson, Christopher M. Walker, and Stanley M. Lemon. Acute hepatitis A virus infection is associated with a limited type I interferon response and persistence of intrahepatic viral RNA. PNAS, June 20, 2011 DOI: 10.1073/pnas.1101939108
Source
Hepatitis C is a continuing public health problem, which is difficult to measure because symptoms occur months to years after infection. The World Health Organization estimates as many as 2 to 4 million people in the United States may have chronic Hepatitis C, and most do not know they are infected. More than a third of those who are long-term carriers may develop chronic liver disease or liver cancer.
"Hepatitis viruses have co-evolved with humans over a very long period of time and they are good at evading the immune system, but nobody understands how Hepatitis C becomes a chronic infection," says Stanley M. Lemon, MD, professor of microbiology and immunology and a member of UNC Lineberger Comprehensive Cancer Center and the Center for Translational Immunology.
Lemon and his colleagues thought that Hepatitis C might become chronic by disrupting the host's interferon response -- part of the innate immune system that protects the body against any kind of 'foreign' invader.
However, their study, published on-line in the Early Edition of the journal Proceedings of the National Academy of Sciences U.S.A., came up with some surprising findings.
In comparing data from experiments with Hepatitis A and Hepatitis C, the team found that Hepatitis A virus, which causes only acute, self-limited disease, is more efficient at inhibiting the host's interferon response, and that the virus can actually linger in the body for almost a year.
"These results undermine the theory that evasion of the interferon response is a key mechanism in the development of chronic Hepatitis C -- the outcome of infection with these viruses is very different, highlighting how little we understand the unique environment within the liver for virus-host interactions," Lemon notes.
"It is actually the acute infection, Hepatitis A, that is stealthier at evading the interferon response."
In addition to Lemon, the research team included Zongdi Feng, Ph.D., and Daisuke Yamane, D.V.M, Ph.D. from UNC-Chapel Hill; Robert Lanford, PhD, of the Texas Biomedical Research Institute and the Southwest National Primate Research Center; Deborah Chavez, MS, and Bernadette Guerra, BS, from the Texas Biomedical Research Institute; Kathleen Brasky, DVM, of the Southwest National Primate Center; Yan Zhou, PhD, and Christopher Walker, PhD, of the Center for Vaccines and Immunity at Nationwide Children's Hospital in Columbus, OH; and Alan Perelson, PhD, from Los Alamos National Laboratory.
The research was funded by the National Institutes of Health.
Journal Reference:
1. Robert E. Lanford, Zongdi Feng, Deborah Chavez, Bernadette Guerra, Kathleen M. Brasky, Yan Zhou, Daisuke Yamane, Alan S. Perelson, Christopher M. Walker, and Stanley M. Lemon. Acute hepatitis A virus infection is associated with a limited type I interferon response and persistence of intrahepatic viral RNA. PNAS, June 20, 2011 DOI: 10.1073/pnas.1101939108
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