January 20, 2011
The rate of stroke diagnoses increased significantly between 1997 and 2006 in people living with HIV, while simultaneously falling in HIV-negative people, according to a study published online January 19 in the journal Neurology and reported by the Los Angeles Times.
Researchers have been reporting for years that cardiovascular disease (CVD) rates are on the rise in people with HIV, looking mostly at the number of heart attacks and clogged arteries in various cohorts. Less is known about the rate of stroke, which is another major form of CVD. It occurs when there is an interruption of the blood supply to any part of the brain. It can cause disability and, in many cases, death.
To explore this matter, Bruce Ovbiagele, MD—from the University of California at San Diego—and Avindra Nath, MD—from Johns Hopkins University in Baltimore—examined the medical records of HIV-positive and HIV-negative individuals from a national database of hospitalized patients who were treated for stroke between 1997 and 2006.
Ovbiagele and Nath found that while the risk of stroke in HIV-negative study participants had fallen by 7 percent over that time period, the risk had actually increased by 60 percent in people with HIV. Moreover, the researchers found that the higher stroke risk was from an increase in ischemic strokes—those caused by blood clots in the brain—rather than strokes caused by ruptured arteries (hemorrhagic stroke).
The authors concede that some of the increased risk might be tied to the fact that more people with HIV are simply living into old age, when strokes become more prevalent. They also point out, however, that the age at which HIV-positive patients experienced a stroke—the majority of whom were in their 50s—remained largely the same over the course of the study, and that this more likely points to both HIV and antiretroviral treatment as causes.
As the LA Times story concluded, “The researchers cautioned HIV physicians to be particularly alert to symptoms that might indicate that a patient is at above-normal risk for a stroke…[but that] the absolute risk of stroke was still very low, less than 0.2 percent.”
Source
January 20, 2011
In-vitro antiviral activity of Solanum nigrum against Hepatitis C Virus
Published on: 2011-01-19
Hepatitis C is a major health problem causes liver cirrhosis, hepatocellular carcinoma and death. The current treatment of standard interferon in combination with ribavirin, has limited benefits due to emergence of resistant mutations during long-term treatment, adverse side effects and high cost.
Hence, there is a need for the development of more effective, less toxic antiviral agents.
Results: The present study was designed to search anti-HCV plants from different areas of Pakistan. Ten medicinal plants were collected and tested for anti-HCV activity by infecting the liver cells with HCV 3a innoculum.
Methanol and chloroform extracts of Solanum nigrum (SN) seeds exhibited 37% and more than 50% inhibition of HCV respectively at non toxic concentration. Moreover, antiviral effect of SN seeds extract was also analyzed against HCV NS3 protease by transfecting HCV NS3 protease plasmid into liver cells.
The results demonstrated that chloroform extract of SN decreased the expression or function of HCV NS3 protease in a dose- dependent manner and GAPDH remained constant.
Conclusion: These results suggest that SN extract contains potential antiviral agents against HCV and combination of SN extract with interferon will be better option to treat chronic HCV.
Author: Tariq JavedUsman AshfaqSana RiazSidra RehmanSheikh Riazuddin
Credits/Source: Virology Journal 2011, 8:26
Source
Hepatitis C is a major health problem causes liver cirrhosis, hepatocellular carcinoma and death. The current treatment of standard interferon in combination with ribavirin, has limited benefits due to emergence of resistant mutations during long-term treatment, adverse side effects and high cost.
Hence, there is a need for the development of more effective, less toxic antiviral agents.
Results: The present study was designed to search anti-HCV plants from different areas of Pakistan. Ten medicinal plants were collected and tested for anti-HCV activity by infecting the liver cells with HCV 3a innoculum.
Methanol and chloroform extracts of Solanum nigrum (SN) seeds exhibited 37% and more than 50% inhibition of HCV respectively at non toxic concentration. Moreover, antiviral effect of SN seeds extract was also analyzed against HCV NS3 protease by transfecting HCV NS3 protease plasmid into liver cells.
The results demonstrated that chloroform extract of SN decreased the expression or function of HCV NS3 protease in a dose- dependent manner and GAPDH remained constant.
Conclusion: These results suggest that SN extract contains potential antiviral agents against HCV and combination of SN extract with interferon will be better option to treat chronic HCV.
Author: Tariq JavedUsman AshfaqSana RiazSidra RehmanSheikh Riazuddin
Credits/Source: Virology Journal 2011, 8:26
Source
Science Center awards 3 research grants
Philadelphia Business Journal - by John George , Staff Writer
Date: Wednesday, January 19, 2011, 4:36pm EST.
The University City Science Center said Wednesday it has awarded three $200,000 grants to area researchers studying cancer, hepatitis C, and microRNA molecules through its QED proof-of-concept program.
The research and development funding includes $100,000 from the Science Center and a $100,000 match from each of three supporting institutions: The Children’s Hospital of Philadelphia, Temple University and the University of Pennsylvania.
In addition to the financial award, each of the three principal investigators will receive one year of continued business guidance to help them bring their technologies to market.
The grant recipients were:
• Linda B. Couto, associate director in the Center for Cellular and Molecular Therapeutics at Children's Hospital of Philadelphia, who is working on a novel treatment for people infected with hepatitis C virus that uses microRNA technology to overcome the problem of drug resistance;
• George P. Tuszynski, a professor of Neuroscience at Temple University’s School of Medicine, who is working on a protein-based therapy for acute myeloid leukemia that shows promise in reverting cultured leukemic cells to normal cells; and
• Marija Drndic, an associate professor at the University of Pennsylvania, who is leading a group of Penn researchers developing a “lab-on-a-chip tool” for measuring microRNA molecules, which regulate gene activity in normal and disease states.
The Science Center reviewed 45 applications for its third round of QED program grants before selecting the three recipients.
Source
Date: Wednesday, January 19, 2011, 4:36pm EST.
The University City Science Center said Wednesday it has awarded three $200,000 grants to area researchers studying cancer, hepatitis C, and microRNA molecules through its QED proof-of-concept program.
The research and development funding includes $100,000 from the Science Center and a $100,000 match from each of three supporting institutions: The Children’s Hospital of Philadelphia, Temple University and the University of Pennsylvania.
In addition to the financial award, each of the three principal investigators will receive one year of continued business guidance to help them bring their technologies to market.
The grant recipients were:
• Linda B. Couto, associate director in the Center for Cellular and Molecular Therapeutics at Children's Hospital of Philadelphia, who is working on a novel treatment for people infected with hepatitis C virus that uses microRNA technology to overcome the problem of drug resistance;
• George P. Tuszynski, a professor of Neuroscience at Temple University’s School of Medicine, who is working on a protein-based therapy for acute myeloid leukemia that shows promise in reverting cultured leukemic cells to normal cells; and
• Marija Drndic, an associate professor at the University of Pennsylvania, who is leading a group of Penn researchers developing a “lab-on-a-chip tool” for measuring microRNA molecules, which regulate gene activity in normal and disease states.
The Science Center reviewed 45 applications for its third round of QED program grants before selecting the three recipients.
Source
Hepatitis C Information Growing Among Veterans
By Mike Bowersock
Published: January 19, 2011
BEXLEY, Ohio -- Hepatitis C is striking Vietnam-era veterans at a rate five times the general public and a local man is working to get the word out.
NBC4 reported about the effort Monday, and since then, the man has received several calls, emails and inquiries.
Hepatitis C can remain undetected for 10, 20, 30 years or more.
So some veterans are just finding out that the reason they're always tired or perhaps have abdominal pains is hepatitis C.
NBC4 has featured Dennis Agin in stories regarding Agent Orange, but he's also discovered he has hepatitis C and has been researching it among veterans.
Agin performed oral surgery while in the Navy in Vietnam and many of the veterans who are discovering they have the virus were medics or somehow came in contact with blood.
After the story on veterans and hepatits C aired on NBC4, several veterans and families of veterans contacted Agin, wanting more information.
"From people who saw the video that you did and they happened to be doing something also and all of a sudden they look and they say that's what I have. That's my problem," said Agin.
He's meeting with some of the veterans, helping them fill out paperwork to see if they're eligible for benefits.
One of the calls Agin received was from a woman's whose father died of hepatitis C and was part of the first Marines to go into Vietnam.
NBC4 will continue to follow the story and provide updates as available.
To contact Dr. Agin, call 877-OHIO-VET or email n8iln@att.net.
Source
Also See: Hepatitis C Cases Appearing More In Vietnam Veterans
Published: January 19, 2011
BEXLEY, Ohio -- Hepatitis C is striking Vietnam-era veterans at a rate five times the general public and a local man is working to get the word out.
NBC4 reported about the effort Monday, and since then, the man has received several calls, emails and inquiries.
Hepatitis C can remain undetected for 10, 20, 30 years or more.
So some veterans are just finding out that the reason they're always tired or perhaps have abdominal pains is hepatitis C.
NBC4 has featured Dennis Agin in stories regarding Agent Orange, but he's also discovered he has hepatitis C and has been researching it among veterans.
Agin performed oral surgery while in the Navy in Vietnam and many of the veterans who are discovering they have the virus were medics or somehow came in contact with blood.
After the story on veterans and hepatits C aired on NBC4, several veterans and families of veterans contacted Agin, wanting more information.
"From people who saw the video that you did and they happened to be doing something also and all of a sudden they look and they say that's what I have. That's my problem," said Agin.
He's meeting with some of the veterans, helping them fill out paperwork to see if they're eligible for benefits.
One of the calls Agin received was from a woman's whose father died of hepatitis C and was part of the first Marines to go into Vietnam.
NBC4 will continue to follow the story and provide updates as available.
To contact Dr. Agin, call 877-OHIO-VET or email n8iln@att.net.
Source
Also See: Hepatitis C Cases Appearing More In Vietnam Veterans
Vertex Pharma's Hep C drug gets priority review
Thu Jan 20, 2011 8:08am EST
* Drug gets priority review status from FDA, Health Canada
* FDA sets action date for May 23
Jan 20 (Reuters) - Vertex Pharmaceuticals Inc (VRTX.O) said its experimental treatment for Hepatitis C got priority review status from health regulators in the United States and Canada.
Cambridge, Massachusetts-based Vertex, which had asked the U.S. Food and Drug Administration for a priority review of data from telaprevir in November, said the agency set an action date for May 23 to decide on the approval.
Priority review status from the FDA reduces the review period by four month, the company said. The same status from Canadian health regulator Health Canada cuts short the review period to six to nine months, compared to a review period of 18 months or more.
Vertex is developing telaprevir in collaboration with Tibotec Pharmaceuticals, a unit of Johnson & Johnson (JNJ.N), and Mitsubishi Tanabe Pharma (4508.T).
Vertex holds rights to market the drug in North America while Tibotec has rights to market it in Europe, South America, Australia, the Middle East and certain other countries. Mitsubishi Tanabe has rights in Japan and certain Far East countries.
Shares of Vertex have risen 15 percent since it applied for the priority review. They closed at $39.45 Wednesday on Nasdaq. (Reporting by Vidya L Nathan in Bangalore)
StocksRegulatory NewsGlobal MarketsHealthcare
Source
Also See: U.S. FDA and Health Canada Grant Priority Reviews for Telaprevir for the Treatment of Hepatitis C
* Drug gets priority review status from FDA, Health Canada
* FDA sets action date for May 23
Jan 20 (Reuters) - Vertex Pharmaceuticals Inc (VRTX.O) said its experimental treatment for Hepatitis C got priority review status from health regulators in the United States and Canada.
Cambridge, Massachusetts-based Vertex, which had asked the U.S. Food and Drug Administration for a priority review of data from telaprevir in November, said the agency set an action date for May 23 to decide on the approval.
Priority review status from the FDA reduces the review period by four month, the company said. The same status from Canadian health regulator Health Canada cuts short the review period to six to nine months, compared to a review period of 18 months or more.
Vertex is developing telaprevir in collaboration with Tibotec Pharmaceuticals, a unit of Johnson & Johnson (JNJ.N), and Mitsubishi Tanabe Pharma (4508.T).
Vertex holds rights to market the drug in North America while Tibotec has rights to market it in Europe, South America, Australia, the Middle East and certain other countries. Mitsubishi Tanabe has rights in Japan and certain Far East countries.
Shares of Vertex have risen 15 percent since it applied for the priority review. They closed at $39.45 Wednesday on Nasdaq. (Reporting by Vidya L Nathan in Bangalore)
StocksRegulatory NewsGlobal MarketsHealthcare
Source
Also See: U.S. FDA and Health Canada Grant Priority Reviews for Telaprevir for the Treatment of Hepatitis C
HCV+ Kidneys Safely Go to HCV+ Recipients?
Ron Shapiro, MD
Posted: 01/20/2011
View Video here
Hi. My name is Ron Shapiro. I am a transplant surgeon at the University of Pittsburgh. Today I want to talk about a recent study that provides long-term outcomes in organ recipients who were hepatitis C-positive and received organs from either hepatitis C-positive donors or hepatitis C-negative donors.
This study from Spain[1] has been published with shorter follow-ups than in the past, and this is the most recent study, now with 5- and 10-year outcomes. Patient survival was unchanged, according to the donor hepatitis C serology. Graft survival at 10 years was inferior in the hepatitis C-positive-to-positive group, but the demographics were different in that both the donors and the recipients were older in the positive-to-positive group, and this could explain a great deal of the inferior 10-year outcomes. When a multivariate analysis was performed, hepatitis C serology was not a significant factor.
This study has, in the past, provided us with some reassurance that for hepatitis C-positive recipients, it did not matter whether the donor was positive or negative. We have been able to use these kidneys in hepatitis C-positive recipients. The study now provides 10-year data confirming the safety of this approach.
One of the holes in this study is that the subtypes of hepatitis C were never characterized, and the serologies in the Spanish donors have generally been related to a single subgroup. However, it is reassuring to know that with long-term follow-up, hepatitis C-positive kidneys can be used in hepatitis C-positive recipients.
Thank you.
Source
Posted: 01/20/2011
View Video here
Hi. My name is Ron Shapiro. I am a transplant surgeon at the University of Pittsburgh. Today I want to talk about a recent study that provides long-term outcomes in organ recipients who were hepatitis C-positive and received organs from either hepatitis C-positive donors or hepatitis C-negative donors.
This study from Spain[1] has been published with shorter follow-ups than in the past, and this is the most recent study, now with 5- and 10-year outcomes. Patient survival was unchanged, according to the donor hepatitis C serology. Graft survival at 10 years was inferior in the hepatitis C-positive-to-positive group, but the demographics were different in that both the donors and the recipients were older in the positive-to-positive group, and this could explain a great deal of the inferior 10-year outcomes. When a multivariate analysis was performed, hepatitis C serology was not a significant factor.
This study has, in the past, provided us with some reassurance that for hepatitis C-positive recipients, it did not matter whether the donor was positive or negative. We have been able to use these kidneys in hepatitis C-positive recipients. The study now provides 10-year data confirming the safety of this approach.
One of the holes in this study is that the subtypes of hepatitis C were never characterized, and the serologies in the Spanish donors have generally been related to a single subgroup. However, it is reassuring to know that with long-term follow-up, hepatitis C-positive kidneys can be used in hepatitis C-positive recipients.
Thank you.
Source
DNA Test for Hep B May Find Infections in Donor Blood
By Kristina Fiore, Staff Writer, MedPage Today
Published: January 19, 2011
Reviewed by Zalman S. Agus, MD; Emeritus Professor
University of Pennsylvania School of Medicine and
Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner
Nucleic acid testing for hepatitis B virus (HBV) in blood donors may catch potential infection during transfusion, researchers said.
The screen picked up nine cases of the virus in a sample of 3.7 million donors -- more than triple the expected infection rate in this population, Susan Stramer, PhD, of the American Red Cross in Rockville, Md., and colleagues reported in the Jan. 20 issue of the New England Journal of Medicine.
"This study showed a higher-than-expected rate of HBV infection with the use of triplex nucleic acid testing, mainly in donors who had been vaccinated against HBV and who would not have been identified by routine screening," they wrote.
Yet they noted that the acute infections resolved quickly, and their clinical significance in terms of transmission potential isn't clear.
Hepatitis B screening in donors currently tests for disease-specific surface antigen (HBsAg) or for antibodies against hepatitis B core antigen (anti-HBc).
Yet not all donors who have hepatitis B DNA are identified during the period before seroconversion.
So the researchers hypothesized that combination nucleic acid testing for hepatitis B and C as well as HIB in a single triplex assay may provide additional safety.
They performed nucleic acid testing on 3.7 million blood donations and further evaluated the hepatitis B DNA-positive samples that were negative for HBsAg and anti-HBc.
They found nine donors who had hepatitis B DNA, which translated to an overall rate of one in 410,540 donations -- far larger than the two to four expected based on modeling studies, the researchers said.
Six of the samples came from donors who'd received the hepatitis B vaccine and had subclinical infections that developed and resolved.
The investigators said the blood of donors with acute infection during the window period is likely to be highly infectious in transfusion recipients, although the significance of infection in vaccinated donors is less clear.
"These acute HBV infections rapidly resolved and are of inconsequential significance, but their potential for transmission remains unresolved," they wrote.
Three patients who weren't vaccinated and tested positive in nucleic acid screening for hepatitis B had acute infection with subgenotype A2, which is the most frequent genotype in the U.S. and is the parent strain of the HBV vaccine.
On the other hand, only one of the six vaccinated donors were infected with the A2 subtype. The others had non-A2 strains.
The researchers said the findings "emphasize the protective effect of the vaccine, since the observed infections were transient, blunted, and without effect on liver function," but noted that it is less effective for non-A2 infections.
Overall, only two cases of liver injury occurred among those nine hepatitis B DNA-positive patients, and they were in unvaccinated donors.
The researchers attributed infection in four of the DNA-positive donors to a chronically infected sexual partner.
They noted that the infrequent detection of transfusion-transmitted infection contributes to the low cost-effectiveness of nucleic acid testing. Yet in their sample, they found that of 75 reactive nucleic acid tests in seronegative blood samples, 25 were confirmed as positive for either hepatitis B, hepatitis C, or HIV.
Thus, they called for the development of new tests in order to get around the high cost of introducing new screening assays for blood donors and concluded that their findings "may be relevant to decisions about the need to implement screening for HBV DNA among blood donors."
The researchers reported relationships with MacoPharma, Novartis, Abbott Diagnostics, Novartis Vaccines and Diagnostics, Abbott, Roche, Siemens, and Gen-Probe.
Primary source: New England Journal of Medicine
Source reference:
Stramer SL, et al "Nucleic acid testing to detect HBV infection in blood donors" N Engl J Med 2011; 364: 236-247.
Source
Published: January 19, 2011
Reviewed by Zalman S. Agus, MD; Emeritus Professor
University of Pennsylvania School of Medicine and
Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner
Nucleic acid testing for hepatitis B virus (HBV) in blood donors may catch potential infection during transfusion, researchers said.
The screen picked up nine cases of the virus in a sample of 3.7 million donors -- more than triple the expected infection rate in this population, Susan Stramer, PhD, of the American Red Cross in Rockville, Md., and colleagues reported in the Jan. 20 issue of the New England Journal of Medicine.
"This study showed a higher-than-expected rate of HBV infection with the use of triplex nucleic acid testing, mainly in donors who had been vaccinated against HBV and who would not have been identified by routine screening," they wrote.
Yet they noted that the acute infections resolved quickly, and their clinical significance in terms of transmission potential isn't clear.
Hepatitis B screening in donors currently tests for disease-specific surface antigen (HBsAg) or for antibodies against hepatitis B core antigen (anti-HBc).
Yet not all donors who have hepatitis B DNA are identified during the period before seroconversion.
So the researchers hypothesized that combination nucleic acid testing for hepatitis B and C as well as HIB in a single triplex assay may provide additional safety.
They performed nucleic acid testing on 3.7 million blood donations and further evaluated the hepatitis B DNA-positive samples that were negative for HBsAg and anti-HBc.
They found nine donors who had hepatitis B DNA, which translated to an overall rate of one in 410,540 donations -- far larger than the two to four expected based on modeling studies, the researchers said.
Six of the samples came from donors who'd received the hepatitis B vaccine and had subclinical infections that developed and resolved.
The investigators said the blood of donors with acute infection during the window period is likely to be highly infectious in transfusion recipients, although the significance of infection in vaccinated donors is less clear.
"These acute HBV infections rapidly resolved and are of inconsequential significance, but their potential for transmission remains unresolved," they wrote.
Three patients who weren't vaccinated and tested positive in nucleic acid screening for hepatitis B had acute infection with subgenotype A2, which is the most frequent genotype in the U.S. and is the parent strain of the HBV vaccine.
On the other hand, only one of the six vaccinated donors were infected with the A2 subtype. The others had non-A2 strains.
The researchers said the findings "emphasize the protective effect of the vaccine, since the observed infections were transient, blunted, and without effect on liver function," but noted that it is less effective for non-A2 infections.
Overall, only two cases of liver injury occurred among those nine hepatitis B DNA-positive patients, and they were in unvaccinated donors.
The researchers attributed infection in four of the DNA-positive donors to a chronically infected sexual partner.
They noted that the infrequent detection of transfusion-transmitted infection contributes to the low cost-effectiveness of nucleic acid testing. Yet in their sample, they found that of 75 reactive nucleic acid tests in seronegative blood samples, 25 were confirmed as positive for either hepatitis B, hepatitis C, or HIV.
Thus, they called for the development of new tests in order to get around the high cost of introducing new screening assays for blood donors and concluded that their findings "may be relevant to decisions about the need to implement screening for HBV DNA among blood donors."
The researchers reported relationships with MacoPharma, Novartis, Abbott Diagnostics, Novartis Vaccines and Diagnostics, Abbott, Roche, Siemens, and Gen-Probe.
Primary source: New England Journal of Medicine
Source reference:
Stramer SL, et al "Nucleic acid testing to detect HBV infection in blood donors" N Engl J Med 2011; 364: 236-247.
Source
U.S. FDA and Health Canada Grant Priority Reviews for Telaprevir for the Treatment of Hepatitis C
- Six-month review date of May 23, 2011 set by FDA-
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for telaprevir and granted the company's request for six-month Priority Review. Telaprevir is Vertex's lead medicine in development for people with genotype 1 chronic hepatitis C. The FDA grants Priority Review to medicines that offer major advances in treatment or provide a treatment where no adequate therapy exists. A target review date of May 23, 2011 is set under the Prescription Drug User Fee Act (PDUFA) for the FDA's approval decision, which is four months earlier than the standard review time of 10 months.
Additionally, Vertex today announced the completion of a New Drug Submission (NDS) to the Therapeutic Product Directorate (TPD) of Health Canada seeking approval for telaprevir in Canada. Telaprevir was also granted Priority Review in Canada, which allows for faster review for promising medicines that address life-threatening or severely debilitating conditions and for which there are few effective therapies already available. Standard review in Canada takes 18 months or more and Priority Review typically shortens the review time to approximately six to nine months.
In December 2010, Janssen-Cilag International NV announced that the European Medicines Agency (EMA) accepted telaprevir for accelerated assessment in Europe, which is granted to new medicines of major public health interest.
"Data from Phase 3 studies showed that when compared to currently available medicines, telaprevir-based combination therapy nearly doubled viral cure rates and cut treatment time in half for the majority of patients new to treatment," said Peter Mueller, Ph.D., Chief Scientific Officer and Executive Vice President of Global Research and Development at Vertex. "We look forward to working with the FDA and Health Canada to make telaprevir available as quickly as possible for people with hepatitis C."
Data to Support the Telaprevir Submissions
The regulatory submissions in the United States, Canada and Europe are supported by data from three Phase 3 studies, known as ADVANCE, ILLUMINATE and REALIZE, which evaluated up to 12 weeks of telaprevir in combination with Pegasys® (pegylated-interferon alfa-2a) and Copegus® (ribavirin) in people chronically infected with genotype 1 hepatitis C virus (HCV) who were new to treatment as well as those who were treated before with currently available medicines but did not achieve a sustained viral response (SVR, or viral cure). In these studies, treatment with telaprevir-based combination therapy resulted in significantly higher viral cure rates compared to approved medicines, regardless of prior treatment experience, race or stage of liver disease. Up to 75 percent of people new to treatment achieved a viral cure with telaprevir-based therapy. The majority of these people were able to complete their course of treatment at six months — half the time needed with currently available medicines. Among those who did not achieve a viral cure with a prior treatment course of currently available medicines, Phase 3 data showed that telaprevir-based combination therapy resulted in viral cure rates three to five times higher compared to re-treatment with currently available medicines. The safety and tolerability results of telaprevir-based combination therapy were consistent across the Phase 3 studies. The most common adverse events regardless of treatment regimen were rash, fatigue, pruritis, headache, nausea, anemia, insomnia, diarrhea, flu-like symptoms and pyrexia, with the majority being mild or moderate in severity.
Vertex provided a summary of Phase 3 results, including SVR and safety data for telaprevir, in its November 23, 2010 press release announcing the NDA submission.
About Telaprevir
Telaprevir is an investigational, oral inhibitor that acts directly on the HCV protease, an enzyme essential for viral replication. To date, more than 2,500 people with genotype 1 hepatitis C have received telaprevir in Phase 2 and Phase 3 studies.
Vertex is developing telaprevir in collaboration with Tibotec BVBA and Mitsubishi Tanabe Pharma. Vertex has rights to commercialize telaprevir in North America. Through its affiliate, Janssen, Tibotec has rights to commercialize telaprevir in Europe, South America, Australia, the Middle East and certain other countries. Mitsubishi Tanabe Pharma has rights to commercialize telaprevir in Japan and certain Far East countries.
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 Approximately 60 percent of genotype 1 patients who undergo an initial 48-week regimen with pegylated-interferon and ribavirin, the currently approved medicines, do not achieve SVR,2,3,4 or viral cure.5 If treatment is not successful and a person does not achieve a viral cure, they remain at an increased risk for progressive liver disease.6,7,8.9,10
Hepatitis C in the United States
Up to 3.9 million people in the United States have chronic hepatitis C and 75 percent of them are unaware of their infection.11 The majority of people with hepatitis C in the U.S. 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 U.S. and is reported to contribute to 4,600 to 12,000 deaths annually.7 By 2029, total annual medical costs in the U.S. for people with hepatitis C are expected to more than double, from $30 billion in 2009 to approximately $85 billion.10
Hepatitis C in Canada
Approximately 250,000 people in Canada have chronic hepatitis C and more than a third of them do not know they are infected.12 Three provinces account for 80 percent of hepatitis C infections in Canada: Ontario (42 percent), British Columbia (22 percent) and Quebec (16 percent).13 Each year up to 5,000 people are newly infected with hepatitis C and in 2007 alone, nearly 8,000 people were infected.12, 13 In 2010, the annual cost of hepatitis C due to medical treatment and lost productivity in Canada was estimated to reach $1 billion.14 By 2022, the number of hepatitis C-related deaths is expected to increase by one-third.15
Additional resources for media are available at: http://investors.vrtx.com/press.cfm.
PEGASYS® and COPEGUS® are registered trademarks of Hoffman-LA Roche.
Special Note Regarding Forward-looking Statements
This press release contains forward-looking statements, including statements regarding (i) the FDA's target review date for the telaprevir NDA, (ii) Priority Review in Canada allowing for faster review of New Drug Submissions, typically shortening the review time to approximately six to nine months and (iii) Vertex working with the FDA and Health Canada to make telaprevir available as quickly as possible for people with hepatitis C. While the company believes the forward-looking statements contained in this press release are accurate, there are a number of factors that could cause actual events or results to differ materially from those indicated by such forward-looking statements. Those risks and uncertainties include, among other things, that Vertex could experience unforeseen delays in obtaining approval to market telaprevir; that there may be varying interpretations of the data from the telaprevir clinical trials; that future outcomes from clinical trials of telaprevir may not be favorable; that future scientific, clinical, competitive or other market factors may adversely affect the potential for telaprevir-based therapy and the other risks listed under Risk Factors in Vertex's annual report and quarterly reports filed with the Securities and Exchange Commission and available through Vertex's website at http://www.vrtx.com/. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.
About Vertex
Vertex creates new possibilities in medicine. Our team aims to discover, develop and commercialize 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.
About Vertex in Canada
In 2009, Vertex established a research and development site in Laval, Quebec through the acquisition of Virochem Pharma, Inc. Vertex is expanding its existing research and development infrastructure with the addition of commercial and medical teams to support the potential launch of telaprevir in Canada.
For more information and to view Vertex's press releases, please visit http://www.vrtx.com/.
(VRTX - GEN)
References:
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 May 25, 2010.
2 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.
3 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.
4 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.
5 Ghany MG, Strader DB, Thomas DL, Seeff, LB. Diagnosis, management and treatment of hepatitis C; An update. Hepatology. 2009;49 (4):1-40.
6 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).
7 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.
8 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.
9 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.
10 Pyenson B, Fitch K, Iwasaki K. Consequences of hepatitis C virus (HCV): Costs of a baby boomer epidemic of liver disease. http://www.natap.org/2009/HCV/051809_01.htm. Updated May 2009. This report was commissioned by Vertex Pharmaceuticals, Inc.
11 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. 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 May 25, 2010.
12 Public Health Agency of Canada. Hepatitis C: Get the facts. You could have it and not know it. http://www.phac-aspc.gc.ca/hepc/pubs/getfacts-informezvous/index-eng.php. Updated September 21, 2010. Accessed January 18, 2011.
13 Public Health Agency of Canada. Modeling the incidence of prevalence of hepatitis C infection and its sequelae in Canada, 2007. http://www.phac-aspc.gc.ca/sti-its-surv-epi/model/results-eng.php. Updated October 20, 2010. Accessed January 18, 2011.
14 Public Health Agency of Canada. A renewed public health response to address hepatitis C: A summary report of the priority-setting process and strategic framework to action. http://www.phac-aspc.gc.ca/hepc/sr-rs/pdf/srhepc-eng.pdf. Updated June 2009. Accessed January 2011.
15 Sherman M, Sharfran S, Burak K, et al. Management of chronic hepatitis C consensus guidelines. Can J Gastroenterol. 2007;21 (Suppl C):25C-34C.
Vertex Pharmaceuticals Incorporated
Media:
Amy Pasqua, 617-444-6992
or
Dawn Kalmar, 617-444-6992
or
Zachry Barber, 617-444-6992
mediainfo@vrtx.com
or
Investors:
Michael Partridge, 617-444-6108
or
Lora Pike, 617-444-6755
or
Matthew Osborne, 617-444-6057
Source: Vertex Pharmaceuticals Incorporated
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CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for telaprevir and granted the company's request for six-month Priority Review. Telaprevir is Vertex's lead medicine in development for people with genotype 1 chronic hepatitis C. The FDA grants Priority Review to medicines that offer major advances in treatment or provide a treatment where no adequate therapy exists. A target review date of May 23, 2011 is set under the Prescription Drug User Fee Act (PDUFA) for the FDA's approval decision, which is four months earlier than the standard review time of 10 months.
Additionally, Vertex today announced the completion of a New Drug Submission (NDS) to the Therapeutic Product Directorate (TPD) of Health Canada seeking approval for telaprevir in Canada. Telaprevir was also granted Priority Review in Canada, which allows for faster review for promising medicines that address life-threatening or severely debilitating conditions and for which there are few effective therapies already available. Standard review in Canada takes 18 months or more and Priority Review typically shortens the review time to approximately six to nine months.
In December 2010, Janssen-Cilag International NV announced that the European Medicines Agency (EMA) accepted telaprevir for accelerated assessment in Europe, which is granted to new medicines of major public health interest.
"Data from Phase 3 studies showed that when compared to currently available medicines, telaprevir-based combination therapy nearly doubled viral cure rates and cut treatment time in half for the majority of patients new to treatment," said Peter Mueller, Ph.D., Chief Scientific Officer and Executive Vice President of Global Research and Development at Vertex. "We look forward to working with the FDA and Health Canada to make telaprevir available as quickly as possible for people with hepatitis C."
Data to Support the Telaprevir Submissions
The regulatory submissions in the United States, Canada and Europe are supported by data from three Phase 3 studies, known as ADVANCE, ILLUMINATE and REALIZE, which evaluated up to 12 weeks of telaprevir in combination with Pegasys® (pegylated-interferon alfa-2a) and Copegus® (ribavirin) in people chronically infected with genotype 1 hepatitis C virus (HCV) who were new to treatment as well as those who were treated before with currently available medicines but did not achieve a sustained viral response (SVR, or viral cure). In these studies, treatment with telaprevir-based combination therapy resulted in significantly higher viral cure rates compared to approved medicines, regardless of prior treatment experience, race or stage of liver disease. Up to 75 percent of people new to treatment achieved a viral cure with telaprevir-based therapy. The majority of these people were able to complete their course of treatment at six months — half the time needed with currently available medicines. Among those who did not achieve a viral cure with a prior treatment course of currently available medicines, Phase 3 data showed that telaprevir-based combination therapy resulted in viral cure rates three to five times higher compared to re-treatment with currently available medicines. The safety and tolerability results of telaprevir-based combination therapy were consistent across the Phase 3 studies. The most common adverse events regardless of treatment regimen were rash, fatigue, pruritis, headache, nausea, anemia, insomnia, diarrhea, flu-like symptoms and pyrexia, with the majority being mild or moderate in severity.
Vertex provided a summary of Phase 3 results, including SVR and safety data for telaprevir, in its November 23, 2010 press release announcing the NDA submission.
About Telaprevir
Telaprevir is an investigational, oral inhibitor that acts directly on the HCV protease, an enzyme essential for viral replication. To date, more than 2,500 people with genotype 1 hepatitis C have received telaprevir in Phase 2 and Phase 3 studies.
Vertex is developing telaprevir in collaboration with Tibotec BVBA and Mitsubishi Tanabe Pharma. Vertex has rights to commercialize telaprevir in North America. Through its affiliate, Janssen, Tibotec has rights to commercialize telaprevir in Europe, South America, Australia, the Middle East and certain other countries. Mitsubishi Tanabe Pharma has rights to commercialize telaprevir in Japan and certain Far East countries.
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 Approximately 60 percent of genotype 1 patients who undergo an initial 48-week regimen with pegylated-interferon and ribavirin, the currently approved medicines, do not achieve SVR,2,3,4 or viral cure.5 If treatment is not successful and a person does not achieve a viral cure, they remain at an increased risk for progressive liver disease.6,7,8.9,10
Hepatitis C in the United States
Up to 3.9 million people in the United States have chronic hepatitis C and 75 percent of them are unaware of their infection.11 The majority of people with hepatitis C in the U.S. 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 U.S. and is reported to contribute to 4,600 to 12,000 deaths annually.7 By 2029, total annual medical costs in the U.S. for people with hepatitis C are expected to more than double, from $30 billion in 2009 to approximately $85 billion.10
Hepatitis C in Canada
Approximately 250,000 people in Canada have chronic hepatitis C and more than a third of them do not know they are infected.12 Three provinces account for 80 percent of hepatitis C infections in Canada: Ontario (42 percent), British Columbia (22 percent) and Quebec (16 percent).13 Each year up to 5,000 people are newly infected with hepatitis C and in 2007 alone, nearly 8,000 people were infected.12, 13 In 2010, the annual cost of hepatitis C due to medical treatment and lost productivity in Canada was estimated to reach $1 billion.14 By 2022, the number of hepatitis C-related deaths is expected to increase by one-third.15
Additional resources for media are available at: http://investors.vrtx.com/press.cfm.
PEGASYS® and COPEGUS® are registered trademarks of Hoffman-LA Roche.
Special Note Regarding Forward-looking Statements
This press release contains forward-looking statements, including statements regarding (i) the FDA's target review date for the telaprevir NDA, (ii) Priority Review in Canada allowing for faster review of New Drug Submissions, typically shortening the review time to approximately six to nine months and (iii) Vertex working with the FDA and Health Canada to make telaprevir available as quickly as possible for people with hepatitis C. While the company believes the forward-looking statements contained in this press release are accurate, there are a number of factors that could cause actual events or results to differ materially from those indicated by such forward-looking statements. Those risks and uncertainties include, among other things, that Vertex could experience unforeseen delays in obtaining approval to market telaprevir; that there may be varying interpretations of the data from the telaprevir clinical trials; that future outcomes from clinical trials of telaprevir may not be favorable; that future scientific, clinical, competitive or other market factors may adversely affect the potential for telaprevir-based therapy and the other risks listed under Risk Factors in Vertex's annual report and quarterly reports filed with the Securities and Exchange Commission and available through Vertex's website at http://www.vrtx.com/. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.
About Vertex
Vertex creates new possibilities in medicine. Our team aims to discover, develop and commercialize 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.
About Vertex in Canada
In 2009, Vertex established a research and development site in Laval, Quebec through the acquisition of Virochem Pharma, Inc. Vertex is expanding its existing research and development infrastructure with the addition of commercial and medical teams to support the potential launch of telaprevir in Canada.
For more information and to view Vertex's press releases, please visit http://www.vrtx.com/.
(VRTX - GEN)
References:
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 May 25, 2010.
2 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.
3 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.
4 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.
5 Ghany MG, Strader DB, Thomas DL, Seeff, LB. Diagnosis, management and treatment of hepatitis C; An update. Hepatology. 2009;49 (4):1-40.
6 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).
7 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.
8 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.
9 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.
10 Pyenson B, Fitch K, Iwasaki K. Consequences of hepatitis C virus (HCV): Costs of a baby boomer epidemic of liver disease. http://www.natap.org/2009/HCV/051809_01.htm. Updated May 2009. This report was commissioned by Vertex Pharmaceuticals, Inc.
11 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. 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 May 25, 2010.
12 Public Health Agency of Canada. Hepatitis C: Get the facts. You could have it and not know it. http://www.phac-aspc.gc.ca/hepc/pubs/getfacts-informezvous/index-eng.php. Updated September 21, 2010. Accessed January 18, 2011.
13 Public Health Agency of Canada. Modeling the incidence of prevalence of hepatitis C infection and its sequelae in Canada, 2007. http://www.phac-aspc.gc.ca/sti-its-surv-epi/model/results-eng.php. Updated October 20, 2010. Accessed January 18, 2011.
14 Public Health Agency of Canada. A renewed public health response to address hepatitis C: A summary report of the priority-setting process and strategic framework to action. http://www.phac-aspc.gc.ca/hepc/sr-rs/pdf/srhepc-eng.pdf. Updated June 2009. Accessed January 2011.
15 Sherman M, Sharfran S, Burak K, et al. Management of chronic hepatitis C consensus guidelines. Can J Gastroenterol. 2007;21 (Suppl C):25C-34C.
Vertex Pharmaceuticals Incorporated
Media:
Amy Pasqua, 617-444-6992
or
Dawn Kalmar, 617-444-6992
or
Zachry Barber, 617-444-6992
mediainfo@vrtx.com
or
Investors:
Michael Partridge, 617-444-6108
or
Lora Pike, 617-444-6755
or
Matthew Osborne, 617-444-6057
Source: Vertex Pharmaceuticals Incorporated
News Provided by Acquire Media
Source
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