CROI 2012: Telaprevir sustained high response rates in treatment-naive HIV patients

Posted on InfectiousDiseaseNews.com March 6, 2012

SEATTLE — Significantly higher response rates were observed with telaprevir combined with peginterferon alfa and ribavirin compared with placebo for the treatment of chronic hepatitis C virus genotype-1 infection in treatment-naive HIV patients.

Douglas T. Dieterich, MD, professor of medicine in the division of hepatology at Mount Sinai School of Medicine in New York, presented findings from a 24-week interim analysis of patients assigned telaprevir (Incivek, Vertex Pharmaceuticals).

“The numbers are impressive — 74% for treatment arm vs. 45% in the control arm,” Dieterich said during a press conference today. “This is a huge leap forward in treatment for HCV and HIV patients.”

Patients were grouped into the following treatment regimens:

• Part A: Patients received no concurrent antiretroviral therapy.
• Part B: Patients were on ART and also an efavirenz-based regimen or on an atazanavir plus ritonavir-based regimen.

Of the 62 patients included in the study, 44 reached week 24 of treatment and are, therefore, included in the current analysis. The mean age of the patients was 46 years; 88% male, and 27% black. Subtype 1a was confirmed in 68% and cirrhosis in 3.3%.

Although CD4 cell count percentage remained unchanged by week 24, absolute CD4 cell counts decreased overall.

At week 24, undetectable HCV RNA levels occurred in 86% of patients assigned treatment and no ART vs. 33% among those assigned placebo; in 75% of patients assigned to treatment who were also on an ART plus efavirenz-based regimen vs. 50% of those assigned placebo; and in 67% of patients assigned to treatment who were also on ART plus atazanavir/ritonavir-based regimen vs. 75% of those assigned placebo.

One patient in the efavirenz-based regimen group and one patient in the atazanavir/ritonavir group achieved HCV RNA breakthrough on telaprevir, according to the researchers.

Compared with placebo, 10% or more of patients assigned to treatment groups experienced vomiting, abdominal pain, nausea, dizziness, depression and pruritus. Both bilirubinemia and hyperbilirubinemia were more common among patients in the atazanavir/ritonavir group.

For more information:

• Dieterich D. #46. Presented at: 19th Conference on Retroviruses and Opportunistic Infections; March 5-8, 2012; Seattle.

Disclosures: The researchers report no relevant financial disclosures.

Perspective

There is a lot of exciting work on hepatitis being presented at CROI. This is the first time that we will have data on cure rates in HIV/HCV coinfected persons treated with new protease inhibitors; a few first-ever in man releases of data.

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CROI 2012: Boceprevir regimen led to high rates of undetectable HCV RNA in HCV/HIV

Posted on InfectiousDiseaseNews.com March 6, 2012

SEATTLE — A boceprevir plus pegylated interferon and ribavirin combination resulted in significantly high rates of undetectable hepatitis C virus RNA at weeks 4, 8, 12, 24 and 48 in patients coinfected with hepatitis C virus genotype-1 and HIV.

“The [sustained virological response] 12 data being presented today is an endpoint that is currently being determined by regulatory authorities to represent a solid sustained virologic response metric,” Mark Sulkowski, MD, of Johns Hopkins University School of Medicine, said during the meeting. “Our data suggest that boceprevir plus pegylated interferon and ribavirin had a sustained virologic response rate of 60.7%, with three patients negative at 4 weeks.”

From November 2009 to December 2010, patients were randomly assigned in a 2:1 fashion to 1.5 mcg/week pegylated interferon plus 600 mg/day to 1,400 mg/day ribavirin and 800 mg boceprevir (Victrelis, Merck) three-times daily (n=64) or to placebo plus pegylated interferon and ribavirin (n=34). The median age of the patients was 43 years; 69% male, and 82% white.

Treatment duration was 44 weeks. Primary outcome measure was an achievement of SVR (undetectable plasma HCV RNA) by week 24 of treatment.

Overall, 61% of patients assigned to the boceprevir arm completed treatment vs. 32% of those assigned placebo by week 48. Compared with an undetectable HCV RNA rate of 29.4% in the placebo arm, the rate was 63.9% in the boceprevir arm.

Treatment failure occurred in 9% of those assigned boceprevir vs. 53% of those assigned placebo. Patients included in the boceprevir arm were more likely to experience adverse events, including a decreased appetite, anemia and neutropenia. HIV RNA virologic failure occurred in two patients in the placebo arm and in three patients in the boceprevir arm.

“Our data suggest that the boceprevir regimen was well tolerated in these patients with HCV/HIV coinfection,” Sulkowski said.

For more information:

• Sulkowski M. #47. Presented at: 19th Conference on Retroviruses and Opportunistic Infections; March 5-8, 2012; Seattle.

Disclosure: The researchers report no relevant financial disclosures.

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Scientists Develop Better Test for Identifying Hepatitis Type

06/03/2012 20:22:00

Madison, Wisconsin - Hepatitis C virus (HCV) comes in many types and subtypes, and knowing these specifics helps determine how long a patient should be treated, doses and types of medication needed and how well the patient will do on treatment.

Scientists in the Molecular Diagnostics Laboratory at UW Hospital and Clinics are now providing doctors and patients much more information about virus type and subtype than before. No other hospital or laboratory in the country routinely offers this level of detail.

"We hope this new information will help clinicians make better judgments about the best course of treatment for each patient," says Dr. William Rehrauer, head of the Molecular Diagnostics Laboratory and assistant professor of pathology and laboratory medicine at UW School of Medicine and Public Health (SMPH).

Rehrauer and colleagues have developed a test that more accurately defines HCV type and subtype than before by looking at multiple locations on the viral genome instead of just one, as was done in the past.

In the process, the scientists also discovered, to their great surprise, a new type of hepatitis C virus never before seen in the United States. The strain, similar to one found in Russia, is probably very rare in North America, they say.

HCV is the most common chronic blood-borne disease in the United States, infecting approximately 3.2 million people. The World Health Organization estimates that 130 million to 170 million people worldwide carry the virus. The infection can cause several kinds of liver diseases, including cirrhosis and cancer.

The hepatitis C virus is divided into six or seven genotypes, or types, each defined by specific genetic information. Each type is further divided into many subtypes, with new types and subtypes being identified regularly. Type 1, subtype a (1a) is by far the most common form of hepatitis C virus in patients in the United States.

Genotype and subtype can significantly influence how, and even if, a patient will be treated.

"Patients with genotype1 do not respond all that well to standard therapies of alpha interferon or the combination of alpha interferon and ribavirin," says Dr. Robert Striker, a UW Hospital infectious disease specialist who sees many hepatitis C virus-infected patients.

The newest drugs have much better response rates but are expensive and produce side effects.

"They work well for genotype 1 viruses in general," says Striker. "While they do work for 1as, the effectiveness is not as high as for 1bs, where they work great."

Called protease inhibitors, the new drugs specifically target the area in the center of the virus genome called the protease, which is responsible for important steps in virus replication.

Genotype is determined by analyzing sequences in the viral genome. Laboratory technologists typically use commercially available tests that focus on a sequence at one end of the hepatitis C virus genome, referred to as 5 prime.

"The 5 prime tests don't provide much information on newly identified types and subtypes," says Striker, a professor of medical microbiology and immunology at the SMPH. "They don't tell you how the protease will respond to treatment."

Rehrauer and his team set out to provide additional sequence information that could be used to better guide treatment. Scientists in the Molecular Diagnostics Laboratory, a division of the hospital's clinical laboratories, are experts at doing this.

Dr. Molly Accola, who leads the efforts, scanned the scientific literature and viral sequence databases for an additional region to test. She found a good candidate at the opposite end of the HCV genome, called 3 prime, which could provide a distinguishing sequence that was better than 5 prime at identifying HCV genotype and subtype.

Accola developed a method to test 3 prime and validated it against the old test. She found that the combination of both regions was more effective at identifying hepatitis C virus types and subtypes than the historical 5 prime sequence alone. The lab began using the new test clinically about two years ago.

"Now, not only do we have a more informative region to test, we can add it to the old information," says Accola. "The combination is much richer in data."

With a molecular profile of the two ends of the genome in hand, Striker's team, which does genomic research on HCV, filled in the rest of the sequence.

Over a year, the scientists analyzed 133 samples with their two-site method and unexpectedly found one patient with type 2b genetic information in the 5 prime area and type 1a in the 3 prime area-a new kind of hepatitis C virus. Such a combined form of two related viruses--in this case a 2b/1a--is called a recombinant.

"HCV-infected patients are frequently exposed to multiple forms of the virus, but very few recombinants between two HCV genotyes have been found," says Rehrauer.

The place where 2b/1a combined--the cross-over point--was at the center of the genome, next to the hepatitis C virus protease where the new drugs work.

"While the 2b/1a recombinant finding was very interesting, the real value of testing the viral genome in two places, in my opinion, is that it lets us be more confident about the subtype determination," Striker says.

Over time, with new medications expected on the market in coming years, such details will matter more and more, he adds.

"The complexity of these viruses has not been appreciated," Striker says.

The recombinant work was published in the Virology Journal.

University of Wisconsin School of Medicine and Public Health

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More patients relapse in Gilead hepatitis C trial

By Deena Beasley

Tue Mar 6, 2012 5:17pm EST

(Reuters) - Two more patients in a 10-patient segment of a mid-stage trial testing Gilead Sciences Inc's experimental hepatitis C drug GS-7977 had the virus return within four weeks of treatment, researchers said on Tuesday.

The company, which recently paid nearly $11 billion to acquire the drug and its developer, Pharmasset, said last month that six out of 10 patients with a prior "null response" to standard hepatitis C therapy saw the virus return within four weeks of treatment with a combination of GS-7977 and the antiviral drug ribavirin.

The latest results from the mid-stage trial bring to eight the number of patients who have relapsed.

One patient has not reached the four-week point and the other showed a response to the drug, Dr. Edward Gane from New Zealand's Auckland City Hospital and the study's lead investigator said here at the Conference on Retroviruses and Opportunistic Infections.

The trial segment he updated involved patients infected with genotype 1 hepatitis C -- the most common, but also the most difficult to treat, subset of the disease.

"The majority of null responders have relapsed post treatment," Dr. Gane said, adding that such patients will likely need either a longer duration of therapy or combination treatment with other direct-acting antiviral agents.

He said the relapsed patients will be offered a "rescue protocol" in the form of another trial of GS-7977 in combination with a different experimental drug.

Shares of Gilead have dropped 18 percent since the company's announcement of the trial results, which suggested that an all-oral treatment for hepatitis C may be further away than many had hoped.

Dr. Gane said ongoing pivotal-stage trials of GS-7977 "should establish that interferon-free treatment is not a dream. It's a reality that should be here within the next five years."

Current hepatitis C drug regimens require injections of interferon, which causes severe flu-like symptoms and cannot be tolerated by some patients.

GS-7977 is designed to block an enzyme essential to the replication of the hepatitis C virus. It is one of a new class of treatments designed to be given without injections of interferon, which helps boost the body's immune system but can also cause debilitating flu-like side effects.

Gilead has said it expects to announce at the end of this month results from a mid-stage trial of GS-7977 in previously untreated hepatitis C patients.

Hepatitis C is a liver-destroying disease that affects some 170 million people worldwide. Untreated, it can lead to cirrhosis, liver cancer and the need for a liver transplant.

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Vertex, Merck hepatitis drugs work in HIV patients

By Deena Beasley

SEATTLE | Tue Mar 6, 2012 3:10pm EST

SEATTLE (Reuters) - Rival hepatitis C drugs from Merck & Co Inc and Vertex Pharmaceuticals Inc are effective in patients also infected with HIV, the virus that causes AIDS, according to data released on Tuesday.

The Vertex drug had the more impressive results, the data showed.

The results from midstage trials follow notification last month from U.S. regulators and Merck that use of the company's Victrelis drug in such "co-infected" patients could lessen the effectiveness of some medicines used to treat patients infected with the human immunodeficiency virus, or HIV.

Those findings involved "boosted" HIV protease inhibitors.

Both Victrelis, also known as boceprevir, and Vertex's Incivek, or telaprevir, are protease inhibitors designed to block an enzyme that the hepatitis C virus requires to replicate.

Since key HIV drugs are also protease inhibitors, which use the same pathway as the new hepatitis C drugs, there is a potential for drug interaction, said Dr. Douglas Dietrich, professor of medicine at New York's Mount Sinai School of Medicine and lead investigator on the Incivek trial.

He said 74 percent of trial patients treated with Incivek followed by the standard regimen of interferon and ribavirin were free of the hepatitis C virus, or HCV, 12 weeks after ending treatment, compared with 45 percent of patients given interferon and ribavirin alone.

There were no instances of a rebound of HIV for patients in the Incivek trial. Side effects seen more frequently with the drug were itching, headache, nausea, rash, fever and depression. No cases of severe rash were reported.

Merck's Phase II trial found that 60.7 percent of patients treated with Victrelis and the standard hepatitis C therapy were free of HCV 12 weeks after treatment, compared with 26.5 percent of patients treated only with interferon and ribavirin.

Three patients on Victrelis and four in the control group had an increase in HIV.

"These Phase II trials, albeit small in size, demonstrate significant improvement" over treatment with interferon and ribavirin alone, said Dr. Mark Sulkowski of Johns Hopkins University School of Medicine in Baltimore, the lead investigator on the Victrelis trial.

The trial results were reported in Seattle at the Conference on Retroviruses and Opportunistic Infections on Tuesday.

"The drugs that are used to treat HIV have certain metabolic effects," said Eliav Barr, Merck's vice president, infectious diseases. "You have to be careful not to mess with those drug levels."

Barr estimated that between 15 percent and 20 percent of U.S. HIV patients are also infected with HCV, a liver-destroying virus which has come to be a leading cause of death for HIV patients.

In the first half of this year, Merck plans to start a larger, pivotal trial of Victrelis in a broader range of HIV patients, with those results expected a couple of years later, Barr said. The company is also conducting a number of drug interaction studies.

Vertex said it is currently enrolling patients in a Phase III study of Incivek combination regimens in people also infected with HCV and HIV.

According to the U.S. Centers for Disease Control and Prevention, 1.2 million Americans have HIV, and one in five adults with HIV do not know they are infected.

Vertex said laboratory studies of Incivek and HIV protease inhibitors had found no harmful effects on antiviral activity when combined with HIV medicines Agenerase (amprenavir) from GlaxoSmithKline Plc, Prezista (darunavir) from Johnson & Johnson's Janssen unit and lopinavir. Slight antagonistic effects were observed on the antiviral activity of Reyataz (atazanavir) from Bristol-Myers Squibb Co.

Merck said last month that a study among healthy volunteers showed Victrelis as lessening the effect of a combination of HIV drug Norvir (ritonavir) from Abbott Laboratories Inc with one of three other anti-HIV pills: Reyataz, Prezista and Abbott's Kaletra (lopinavir/ritonavir).

In afternoon trading, Vertex shares were down 77 cents or 1.9 percent to $39.63 and Merck shares were down $1.04 or 2.7 percent to $37.41 As the broad market fell. Merck said earlier its first-quarter earnings would trail Wall Street estimates.

(Editing by Michele Gershberg and Gerald E. McCormick)

Source

Also See:

CROI 2012: Results from Investigational Studies with VICTRELIS™ (boceprevir) Presented at the Conference on Retroviruses and Opportunistic Infections to Understand Potential Use in Patients Coinfected with Chronic Hepatitis C and HIV-1

CROI 2012: Data from Phase 2 Study of an INCIVEK® Combination Regimen Showed 74% of People Co-Infected with Hepatitis C and HIV Had Undetectable Hepatitis C Virus 12 Weeks After Treatment Ended (SVR12)

Biliary Atresia Linked to Food Allergy Post Liver Transplant

Kate Johnson

March 6, 2012 (Orlando, Florida) — The reason pediatric liver transplant patients have high rates of new-onset food allergy might be hidden in their indication for transplant, Japanese researchers reported here at the American Academy of Allergy, Asthma and Immunology 2012 Annual Meeting.

Patients who require transplantation for biliary atresia have higher rates of new-onset food allergy than patients with other indications for liver transplantation, said Tetsuo Shoda, MD, from the National Center for Child Health and Development in Tokyo, Japan.

In particular, those with a history of intestinal surgery had a 6-fold increase in new-onset food allergy, compared with those with no history, he explained.

The phenomenon of new-onset food allergy after transplantation is seen predominantly in liver recipients; its prevalence has been estimated to be between 10% and 20%, Dr. Shoda told Medscape Medical News.

Findings from previous studies have suggested that immunosuppressant medications such as tacrolimus increase intestinal permeability and trigger allergy, Dr. Shoda said. But this does not explain why new-onset food allergy is more common in liver recipients than in recipients of other organs.

He and his colleagues retrospectively reviewed the charts of 123 children who underwent living-donor liver transplantation at his institution from November 2005 to May 2010. Median age at the time of transplantation was 8 months.

Children received standard doses of tacrolimus and low-dose steroids for initial immunosuppression.

There was a 90% patient survival rate, and therefore 105 patients for analysis.

The indication for liver transplantation was biliary atresia in 44% of these patients, congenital metabolic disease in 25%, fulminant hepatic failure in 18%, liver cirrhosis in 5%, congenital absence of the portal vein in 3%, congenital hepatic fibrosis in 2%, and hepatic tumor in 1%.

Over a median of 10.5 months, 15 patients developed new-onset food allergy after liver transplantation, for a cumulative incidence of 14.3%. The majority of allergic reactions (86%) were urticaria or angioedema, but 47% were gastrointestinal symptoms.

The most common allergen was egg (53%), and 10 patients reacted to more than 2 food allergens. The median total immunoglobulin E level was 438.5 IU/mL.

There was a significant trend toward higher rates of food allergy in patients with biliary atresia than in those without (P = .012).

In the final analysis, the strongest risk factors for the development of new-onset food allergy were being younger than 12 months at the time of surgery (odds ratio [OR], 11.78; P = .003) and having a history of intestinal surgery (OR, 6.69; P = .009).

"Biliary atresia patients usually have had previous intra-abdominal surgeries, which might increase their risk for food problems, causing easier sensitization; after that, the tacrolimus is added," said Dr. Shoda.

Dr. Shoda has disclosed no relevant financial relationships.

American Academy of Allergy, Asthma and Immunology (AAAAI) 2012 Annual Meeting: Abstract 131. Presented March 3, 2012.

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Hepatitis C Patients Relapse on Gilead’s Experimental Medicine in Study

By Ryan Flinn - Mar 6, 2012 11:46 AM ET

Gilead Sciences Inc. (GILD), which paid $10.8 billion to buy Pharmasset Inc. (VRUS) for its hepatitis C pill, said the number of patients who relapsed after they stopped taking the treatment has increased.

Eight of nine patients with the most-common form of the virus in the U.S. had a relapse within four weeks after stopping use of the medicine, GS-7977, and ribavirin, according to research presented today at the Conference on Retroviruses and Opportunistic Infections in Seattle. The patients in the study weren’t helped by prior therapies.

Gilead announced last month that six patients relapsed, sending shares down the most in 11 years. A longer duration or combination with other therapies may help these patients, said researcher Edward Gane, deputy director and hepatologist of the New Zealand Liver Transplant Unit at Auckland City Hospital.

“It’s clear the treatment options for this very difficult to treat group will either be longer duration of 7977 plus ribavirin, or alternatively, the addition of another direct acting antiviral,” Gane said at the meeting.

Last year, Pharmasset reported data on PSI-7977 showing that 40 patients with genotypes 2 and 3 who received the therapy were responsive after 12 weeks. About half the patients had been followed up to 24 weeks, and they were all cured.

Hepatitis C is a viral infection that can lead to swelling of the liver. As many as 170 million people globally carry the virus, which is transmitted through exposure to infected blood, and more than 350,000 die from related illnesses each year, according to the Geneva-based World Health Organization.

Gilead declined 1.4 percent to $45.59 at 11:41 a.m. New York time.

To contact the reporter on this story: Ryan Flinn in San Francisco at rflinn@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

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One in Four U.S. HIV Patients Don't Stay in Care, Penn Study Shows

Baligh Yehia

Media Contact:Holly Auer | holly.auer@uphs.upenn.edu | 215-349-5659

March 5, 2012

Only about 75 percent of HIV/AIDS patients in the United States remain in care consistently, according to new research from the Perelman School of Medicine at the University of Pennsylvania published online this week in AIDS. The study of patients across the United States is the first to provide a comprehensive national estimate of HIV care retention and information about patients who are most likely to continue their treatment over time.
"Helping patients with HIV stay in care is a key way to reduce their chances of getting sick from their disease and prevent the spread of HIV in the community. Our findings show that too many patients are falling through the cracks," says the study's lead author, Baligh R. Yehia, MD, a fellow in the division of Infectious Disease and the Health Policy Research Program at Penn Medicine. "The benefits of keeping patients in care are clear both for patients and the community at large, and it may even result in decreased health care costs by preventing unnecessary hospitalization for an acute illness."

The researchers studied 17,425 adult patients cared for at 12 clinics within the HIV Research Network, a consortium that cares for HIV-infected patients across the nation, between 2001 and 2008. Just 42 percent of patients studied had what researchers defined as "no gap" in treatment — intervals of no more than six months in between outpatient visits — over the timeframe studied, while 31 percent had one or more seven- to 12-month gaps in care. Twenty-eight percent appeared to have gone without care for more than a year on one or more occasions. Since there is no gold standard on the best way to measure retention in care, the team used three different measures of retention to examine each patient’s visit record.

Click here to view the full release.

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Diet Can Cut Weight Tied to HIV Treatment

By Michael Smith, North American Correspondent, MedPage Today

Published: March 05, 2012

Reviewed by Dori F. Zaleznik, MD; Associate Clinical Professor of Medicine, Harvard Medical School, Boston.

The right diet can prevent the weight gain, fat changes, and dyslipidemia associated with treatment for HIV, researchers reported.

In a prospective randomized trial, patients who followed a diet aimed at reducing total and low-density lipoprotein cholesterol avoided the changes often linked to highly active anti-retroviral therapy (HAART), according to Jorge Ribeiro, MD, SCD, and colleagues at the Hospital de Clínicas de Porto Alegre in Porto Alegre, Brazil.

After a year of follow-up, just 21% of those in the diet group had a lipid profile compatible with dyslipidemia, compared with 68% of the control group, Ribeiro and colleagues reported in the March 13 issue of the Journal of the American College of Cardiology.

The study is the first to try to isolate the effect of diet in people just starting HAART, the researchers said. Previous controlled studies, looking at diet and exercise together in people already on treatment, found little benefit, they noted.

"These findings indicate that nutritional intervention should be considered for all patients who start HAART," the researchers concluded.

Ribeiro and colleagues analyzed outcomes for 81 patients who started treatment from March 2004 to April 2006. All were asked about their current diet during assessment for the study, and after entry all were given dietary counseling.

Those in the diet group, however, were given more detailed instruction, including individualized diets with 25% of the total calories in lipids, 15% in proteins, and 60% in carbohydrates, including 30 g/day of fiber and 200 mg dietary cholesterol.

They also got nutritional guidance, based on the National Cholesterol Education Program, from a registered dietitian four times during the year-long trial.

Analysis showed:

• Nine of the 38 patients analyzed in the diet group had alterations in their lipid profile compatible with dyslipidemia, compared with 26 of the 43 in the control group.
• The diet reduced the percentage of calories from fat from 31% on average to 21%, but there was no change among controls.
• Total cholesterol was unchanged in the diet group, but rose from 151 to 190 mg/dL among controls.
• Similarly, low-density lipoprotein cholesterol levels were unchanged among those on the diet, but increased by a mean of 85 to 106 mg/dL among controls.
• Plasma triglycerides were reduced by diet from 135 to 101 mg/dL on average, but increased from 134 to 160 mg/dL among controls.
• Body mass index was stable in the diet group, but increased among those in the control group, from 23.2 to 26.2, by the end of the trial.
• All the differences were significant at P<0.001.

The researchers cautioned that the study did not have an exercise component, so the findings don't eliminate the possibility that a broader intervention might have different results.

The lipid changes that were observed are clinically relevant, according to James Stein, MD, of the University of Wisconsin School of Medicine and Public Health in Madison, Wisc.

The 15% difference between the groups in total cholesterol "would be expected" to yield a long-term reduction in the risk of cardiovascular disease of about 25% to 30%, Stein said in an accompanying editorial.

But he noted that all participants at the start of the study consumed markedly more total cholesterol than a typical American, which might have "accentuated the reductions" among those who started the diet.

Nonetheless, he argued, the findings are "an important addition to the literature and re-emphasize that dietary interventions can be as effective as low-dose statin therapy for preventing and treating dyslipidemia associated with HAART."

The study had support from the Brazilian National Council for Scientific and Technological Development, the Rio Grande do Sul Research Foundation, and the Fund for Incentive in Research of the Hospital de Clínicas de Porto Alegre.

The journal said the authors reported that they have no relevant relationships to disclose.

The journal said Stein reported being on data and safety monitoring committees for Abbott, Lilly, and Takeda.

Primary source: Journal of the American College of Cardiology
Source reference:
Lazzaretti RK, et al "Dietary intervention prevents dyslipidemia associated with highly active antiretroviral therapy in human immunodeficiency virus type 1–infected individuals: a randomized trial" J Am Coll Cardiol 2012; 59: 979–88.

Additional source: Journal of the American College of Cardiology
Source reference:
Stein JH "Nutritional therapy to prevent dyslipidemia in patients starting antiretroviral therapy for human immunodeficiency virus" J Am Coll Cardiol 2012; 59: 989-990.

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What Does Your State's HIV Disclosure Law Require?

By Andrew Chow, JD at FindLaw.com

Mon Mar 5, 2012 1:19am EST

A former pro wrestler's recent conviction for not telling his sexual partners he was HIV-positive raises questions about state HIV disclosure laws. How common are these laws, and what do they require?

A jury convicted Andre Davis, 29, who once wrestled under the name "Gangsta of Love," under Ohio's HIV disclosure law. Davis was sentenced to 32 years in prison.

Ohio is among at least 24 states that have enacted HIV disclosure laws, according to a 2008 study in The Journal of Law, Medicine & Ethics. Two broad types of laws exist, the study found:

State HIV disclosure laws can be classified as either "strict" or "flexible," according to the 2008 study. Strict laws, such as Ohio's, require people to disclose their HIV status to sexual partners prior to any type of sexual contact.

Under "strict" HIV disclosure laws, sexual contact includes intercourse, oral sex, and penetration by any object. Conviction usually does not require the emission of semen, or the infection of a victim.

Along with Ohio, laws in Arkansas, Michigan, and New Jersey also fall into the "strict" category, the study found.

Compare those laws with so-called flexible laws regarding HIV disclosure. California's law is the "least restrictive," the study found: For perpetrators to be convicted, they must engage in unprotected intercourse and infect their partner with HIV.

Under "flexible" disclosure laws, people who are HIV positive can legally use condoms and perform sex acts other than intercourse, without having to disclose their HIV status.

So which type of law is more effective? It's not clear, but either type is better than having no law, the study concluded. Flexible laws may actually produce a greater reduction in the risk of infection, because of the "safer sex" options available to HIV-positive sexual partners, the authors said.

Aside from the states mentioned above, others with HIV disclosure laws include Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Louisiana, Maryland, Missouri, Nevada, North Dakota, Oklahoma, South Carolina, South Dakota, Tennessee, Virginia, and Washington state.

Related Resources:

• Preventing HIV Transmission via HIV Exposure Laws: Applying Logic and Mathematical Modeling to Compare Statutory Approaches to Penalizing Undisclosed Exposure to HIV (The Journal of Law, Medicine & Ethics)
• Ex-Wrestler 'Gangsta of Love' Gets 32 Years for Having HIV Sex (FindLaw's Tarnished Twenty)
• HIV Disclosure Laws (eHow)
• State Criminal Laws (FindLaw)
• Browse Criminal Defense Lawyers by Location (FindLaw)

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Researchers Pursue Promising New Approach in the Treatment of Liver Cancer

Released:3/5/2012 1:40 PM EST
Embargo expired: 3/5/2012 3:00 PM EST
Source:Boston University College of Arts & Sciences

Newswise — Hepatocellular carcinoma (HCC), or primary cancer of the liver, is the fifth most common cancer worldwide. Despite the prevalence of this disease, until now there has been no effective, systemic treatment. Thanks to a team of researchers in Boston University’s Departments of Biology and Chemistry, and the Program in Molecular Biology, Cell Biology, and Biochemistry, that may be about to change.

The BU research team and collaborators recently discovered a promising new protein target for chemotherapy in the treatment of liver cancer—the transcription factor LSF. (Transcription factors are regulatory proteins that bind genomic DNA near the start of genes, either promoting or inhibiting the transcription or copying of the gene.) LSF is found in high levels in the tumor tissue of patients with liver cancer and has been demonstrated to promote the development of cancer (oncogenesis) in studies using laboratory rodents.

Central to their findings, the BU scientists identified small molecules that effectively inhibit LSF cellular activity, which in turn slows the growth of the cancer. In particular, one such molecule, called Factor Quinolinone Inhibitor 1 (FQI1), derived from a lead compound, was found to inhibit the ability of LSF to bind DNA both in extracts (in vitro, as determined by electrophoretic mobility shift assays), and in cells. Consistent with inhibiting LSF activity, FQI1 also eliminates the ability of LSF to turn up transcription. FQI1 also demonstrates antiproliferative activity, or the ability to prevent or retard the growth of cells. While FQI1 quickly causes cell death in LSF-overexpressing cells, including liver cancer cells, healthy cells are unaffected by the treatment. This phenomenon has been called oncogene addiction, where tumor cells are “addicted” to the activity of an oncogenic factor for their survival, but normal cells can do without it. This is very encouraging for use of such compounds clinically.

Quantitative analysis of FQI1 (based on a concordant structure-activity relationship of a panel of 23 quinolinones) strongly suggests that its growth inhibitory activity focuses on a single biological target or family. This focus, coupled with the striking correlation between the concentrations required for antiproliferative activity and for inhibition of LSF transactivation indicates that LSF is that specific biological target of FQI1.

Building on the in vitro trials, the researchers tested the efficacy of FQI1 in inhibiting liver cancer tumor growth by injecting HCC cell lines into rodent models. FQI1 was observed to significantly inhibit tumor growth with no observable side effects (general tissue cytotoxicity). These dramatic findings support the further development of LSF inhibitors as a promising new chemotherapy treatment for liver cancer.

The team’s findings have been published in the article (Antiproliferative small molecule inhibitors of transcription factor LSF reveal oncogene addiction to LSF in hepatocellular carcinoma) in the Proceedings of the National Academy of Science (PNAS) (www.pnas.org/lookup/suppl/doi:10.1073/pnas.1121601109). The co-principal investigators are Ulla Hansen, Professor of Biology, and Scott Schaus, Associate Professor of Chemistry, Boston University.

Contributing authors are Trevor J. Grant, Girish Barot, Hang Gyeong Chin, Sarah Woodson, Jennifer Sherman, and Tracy Meehan, Department of Biology, Boston University; Joshua A. Bishop, Lisa M. Christadore, and John Kavouris, Department of Chemistry, Center for Chemical Methodology and Library Development at Boston University; Sriharsa Pradhan, New England BioLabs, Inc., Ipswich, MA; Ayesha Siddiq, Rachel Gredler, Xue-Ning Shen, and Devanand Sarkar, Department of Human and Molecular Genetics, Virginia Commonwealth University School of Medicine, Richmond, VA; Laura A. Briggs and William H. Andrews, Sierra Sciences, LLC, Reno, NV; and Kevin Fitzgerald, Alnylam Pharmaceuticals, Inc., Cambridge, MA.

About Boston University—Founded in 1839, Boston University is an internationally recognized private research university with more than 30,000 students participating in undergraduate, graduate, and professional programs. As Boston University’s largest academic division, the College and Graduate School of Arts & Sciences is the heart of the BU experience with a global reach that enhances the University’s reputation for teaching and research.

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IAPAC Guidelines Offer Recommendations to Optimize Entry into and Retention in HIV Care, and Treatment Adherence

PRESS RELEASE

March 5, 2012, 5:36 p.m. EST

New Guidelines e-Published Today by Annals of Internal Medicine

WASHINGTON, March 5, 2012 /PRNewswire via COMTEX/ -- The International Association of Physicians in AIDS Care (IAPAC) today announced the publication of a new set of evidence-based guidelines meant to optimize entry into and retention in HIV care and adherence to HIV treatment. The "Guidelines for Improving Entry into and Retention in Care and Antiretroviral Adherence for Persons with HIV" were developed by an expert IAPAC Panel and e-published today by the Annals of Internal Medicine.

The guidelines include recommendations in several key areas, including: entry into and retention in care; monitoring adherence to HIV care and antiretroviral therapy (ART); interventions to improve ART adherence including those involving choice of ART regimens; adherence tools for patients; education and counseling; and health system and service delivery interventions. The needs of special populations (such as pregnant women, individuals with mental health and substance use disorders, homeless and marginally housed individuals, incarcerated individuals, and children and adolescents) are also addressed in the guidelines, as are recommendations for future research in these areas.

"Over the last 15 years, we have made astounding progress in HIV treatment, resulting in longer and healthier lives for people living with HIV. Yet many people are unable to optimally benefit from these advances because of delayed diagnosis and multiple challenges to entering and staying in medical care," said Melanie A. Thompson, MD, co-chair of the IAPAC Panel. "Once receiving potent treatment for HIV, many struggle to take their drugs consistently. Unfortunately, missed doses and drug holidays lead to resistant virus and, often, to treatment failure. Ultimately, both individual and public health depend on helping patients to successfully negotiate all of the steps of this treatment cascade."

According to the US Centers for Disease Control and Prevention (CDC), only 69 percent of HIV-positive persons in the United States enter HIV care, 59 percent are retained in care, and only 28 percent of Americans living with HIV have an undetectable viral load.(1) A recent African study found that more than two-thirds of HIV-infected individuals were lost from care if they were not yet eligible for drug treatment.(2)

In addition, a review of 84 observational studies - or 33,199 adults on ART - revealed that only 62 percent achieved adherence of at least 90 percent of prescribed ART doses.(3) Adherence to ART has been shown to be an important predictor of achieving adequate suppression of HIV replication, which is required to minimize resistance to HIV treatments, slow disease progression, delay AIDS-related death, and decrease the transmission of HIV to others.

"These guidelines are the foundation of an evolving blueprint that practitioners and health systems can use as a resource to improve entry into and retention in HIV care as well as adherence to HIV treatments," said Thompson, who is also Principal Investigator of the AIDS Research Consortium of Atlanta. The Panel co-chair is Jean B. Nachega, MD, PhD, of Johns Hopkins University/Stellenbosch University, Baltimore, MD, USA, and Cape Town, South Africa, respectively.

"IAPAC is proud of the work advanced by our Panel in developing these pioneering guidelines, which we hope will help strengthen the three pillars of HIV treatment success - entry into and retention in care, as well as ART adherence," said Jose M. Zuniga, PhD, MPH, IAPAC's President. "We have known for some time that much more attention is required to optimize the way in which HIV-positive patients are linked to and retained on HIV treatment so that they derive the full benefit of existing care, treatment, and support. These guidelines are an important step in that direction."

Zuniga further identified some immediate steps IAPAC is taking to implement the guidelines' recommendations. In the next several months, IAPAC will launch a multidisciplinary continuing education-accredited online activity to educate physicians, nurses, pharmacists, and psychologists about the guidelines' recommendations. Peer educator and patient-oriented activities to increase health and HIV literacy, and to facilitate guidelines-recommended behavioral interventions are also planned.

Guidelines development was jointly sponsored by IAPAC and the US National Institutes of Health's Office of AIDS Research.

The e-published guidelines will be available at www.annals.org . A date for print publication of the guidelines in the Annals of Internal Medicine is pending.

(1) Centers for Disease Control and Prevention. Vital signs: HIV prevention through care and treatment - United States. MMWR. 2011;60:1618-1623.

(2) Rosen S, Fox MP. Retention in HIV care between testing and treatment in sub-Saharan Africa: A systematic review. PLoS Medicine. 2011;8(7):e1001056.

(3) Ortego C, Huedo-Medina TB, Llorca J, et al. Adherence to highly active antiretroviral therapy (HAART): A meta-analysis. AIDS Behav. 2011;15(7):1381-1396.

The International Association of Physicians in AIDS Care (IAPAC) is a non-profit medical association representing more than 17,000 clinician-members in over 100 countries. Its mission is to improve the quality of care, treatment, and support provided to people living with HIV/AIDS, hepatitis, malaria, and tuberculosis through education, research, global health, and advocacy activities advanced by its clinician-members. Visit www.iapac.org for more information about IAPAC.

SOURCE International Association of Physicians in AIDS Care

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Wilmot Researchers Create New Way to Study Liver Cancer

06/03/2012 04:47:00

Will provide a base for study and research of rising form of the disease

Researchers at the University of Rochester Medical Center’s James P. Wilmot Cancer Center have made significant strides in the study of a primary cancer of the liver– Intrahepatic Cholangiocarcinoma (IHCC), also called biliary tract cancer. Their work has been published online and in print editions of Cancer Research, the most frequently cited cancer journal in the world.

Aram Hezel, M.D., an assistant professor of Hematology/Oncology in the Department of Medicine at URMC, is the corresponding author of the study that examined the role of genes commonly mutated in human cancers and their role in the growth of Intrahepatic Cholangiocarcinoma, a form of bile duct cancer.

Hezel and fellow researchers from URMC and Massachusetts General Hospital /Harvard Medical School succeeded in developing the first genetically engineered mouse model of IHCC that they hope will provide a valuable, new tool in further research of this disease. A mouse model is important to researchers as it enables them to test dozens or even hundreds of potential treatments in mice in a short span of time, accelerating the discovery process.

The model Hezel and his team created incorporates two of the most common mutations in humans – activating mutations of Kras and deletion of p53 oncogenes. An oncogene is a modified gene that increases the malignancy of a tumor cell. Some oncogenes, usually involved in early stages of cancer development, increase the chance that a normal cell develops into a tumor cell, possibly resulting in cancer.

“This is a new model of a less common liver tumor that we have not yet had good ways to study,” Hezel said. This represents the first good model that can be used as a tool to try to better understand this disease.”

Intrahepatic Cholangiocarcinoma is a primary cancer of the liver. It is thought to arise from the bile ducts, a series of branching tubes within the liver that deliver bile (which is produced by the liver) to the gallbladder and small intestine. Bile breaks down fats found in foods and also helps the body get rid of waste material filtered out of the bloodstream by the liver.

The disease is diagnosed in approximately 6,000 people per year, and its occurrence is rising at a rate that makes it among the fastest growing liver cancers, for reasons scientists have not yet been able to pinpoint. Some suspect that it may be due to doctors having better tests to diagnose this type of cancer more accurately. The tumors are typically very aggressive and highly prone to metastasis at an early stage, leading to poor prognosis. To date, many aspects of IHCC’s biology and genetic makeup, as well as its cells of origin, have eluded scientists.

The model provides a relevant foundation for further understanding of the earliest, precancerous stages of IHCC, a better understanding of the tumor biology, and for evaluating effective treatments. The group has found that chloroquine - a drug commonly used to treat malaria – has been effective in treating IHCC in the mouse model.

“We’ve not yet had good ways to study these mutations and their effects on the biliary system in humans,” Hezel stated. “Among the problems with understanding this cancer is trying to get a handle on where these tumors come from and what steps lead up to them. We tend not to have lots of biopsies of the liver. Effective screening tests for other cancers provide samples that can be studied and provide an indication of where that cancer is coming from; that’s not the case with this form of cancer. We’ve been able to make genetic changes as seen in humans and place it in a mouse model. By studying mice, we think we can learn what cells the disease comes from. We hope we have provided step upward towards a better view of the disease, both for ourselves and for others studying it.”

Co-investigators in the study included Hartmut “Hucky” Land, Ph.D., chair of the Department of Biomedical Genetics at the University of Rochester School of Medicine and Dentistry (SMD); Michael O’Dell, B.S., Wilmot Cancer Center; Christa Whitney-Miller, M.D., assistant professor in the Department of Pathology and Laboratory Medicine (SMD); Valerie Grose, B. S.. Wilmot Cancer Center; Randall Rossi, M.S., Wilmot Cancer Center; and Vikram Deshpande, M.D., Andrew Zhu, M.D., Ph.D, and Nabeel Bardeesy, Ph.D., all of Massachusetts General Hospital/Harvard Medical School.

For Media Inquiries:
Michael Tedesco
(585) 276-5788
Email Michael Tedesco

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Idenix Pharmaceuticals Announces Declaration of a Patent Interference by the USPTO

CAMBRIDGE, Mass., March 6, 2012 /PRNewswire/ -- Idenix Pharmaceuticals, Inc. (NASDAQ: IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced that the United States Patent and Trademark Office (USPTO) declared a patent interference between Idenix's U.S. Patent Application no. 12/131,868 and Pharmasset Inc.'s (acquired by Gilead Sciences) U.S. Patent no. 7,429,572, both related to certain nucleoside compounds useful in treating patients with hepatitis C virus (HCV) infection.

"We are confident in our robust intellectual property position. While the claims in this interference are not related to our nucleotide inhibitor, IDX184, or any other candidate in our pipeline, we believe it is important to deepen the strength of our existing patent portfolio," said Ron Renaud, Idenix's President and Chief Executive Officer.

A patent interference is an administrative proceeding conducted by the USPTO in order to determine which party is entitled to a patent when two or more parties claim patent rights to the same technology. Under current U.S. law, a patent is awarded to the first party to invent a particular technology, subject to certain limitations. The applicant who filed the earlier patent application is referred to as the senior party in the patent interference and the applicant with the later filing date is referred to as the junior party. The junior party bears the burden of proof to demonstrate that it invented the technology in question before the senior party.

In this case, the USPTO has initially determined that Idenix is the senior party and that Pharmasset Inc. (acquired by Gilead Sciences) is the junior party.

ABOUT IDENIX

Idenix Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is a biopharmaceutical Company engaged in the discovery and development of drugs for the treatment of human viral diseases. Idenix's current focus is on the treatment of patients with hepatitis C infection. For further information about Idenix, please refer to www.idenix.com.

FORWARD-LOOKING STATEMENTS

This press release contains "forward-looking statements" for purposes of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995, including but not limited to the statements regarding the Company's position in its interference proceedings with Gilead Sciences. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words "expect," "plans," "anticipates," "intends," "will," and similar expressions are also intended to identify forward-looking statements, as are expressed or implied statements with respect to the Company's intellectual property rights and potential pipeline candidates. Actual results may differ materially from those indicated by such forward-looking statements as a result of risks and uncertainties, including but not limited to the Company's ability to obtain, maintain and enforce patent and other intellectual property protection for its product candidates and its discoveries. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. These and other risks which may impact management's expectations are described in greater detail under the heading "Risk Factors" in the Company's annual report on Form 10-K for the year ended December 31, 2010, and the quarterly report on Form 10-Q for the quarter ended September 30, 2011, each as filed with the Securities and Exchange Commission (SEC) and in any subsequent periodic or current report that the Company files with the SEC.

All forward-looking statements reflect the Company's estimates only as of the date of this release (unless another date is indicated) and should not be relied upon as reflecting the Company's views, expectations or beliefs at any date subsequent to the date of this release. While Idenix may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, even if the Company's estimates change.

Idenix Pharmaceuticals Contacts:
Kelly Barry (617) 995-9033  (media)
Teri Dahlman (617) 995-9807  (investors)

SOURCE Idenix Pharmaceuticals, Inc.

RELATED LINKS
http://www.idenix.com

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Some liver damage can be reversed through exercise

Updated: 2012-03-05 16:42:38 CST

Most people associate liver problems like cirrhosis with years of heavy drinking. However, people who have never touched a drop of liquor in their lives are increasingly receiving unhealthy liver panel test results. The cause is obesity.

Excess body fat is a risk factor for a condition known as non-alcoholic fatty liver disease. It occurs when the liver is unable to clear the excess fat from the blood and instead stores it. This can cause scarring and loss of healthy function, according to the Mayo Clinic. However, it is possible to reverse the condition.

Experts from the Baylor College of Medicine recently told the school's news source that every pound a person loses gets them one step closer to healthy liver function. This can be accomplished through a healthy diet and exercise.

"Losing 10 percent body weight primarily reduces fat inside the abdomen, which triggers a significant amount of liver healing," Dr. John Vierling told the news source. "It's easy for people to get discouraged when it comes to weight loss, but understanding that every pound lost is helping your liver heal is motivating."

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National Advocates Speak Out About Bio-medical Research Priorities

By Srebrenka Kac on Mar 6, 2012

Americans must demand priority for bio-medical research with the clear focus on a greater parity in funding for chronic conditions. Bill Remak, FAIR Foundation member and patient advocate, passionately urges all patients to take action and voice their concerns by writing and calling their representatives about the disparities in research funding.

The new sample prepared letter can be found here. Also visit the FAIR Foundation website to get the facts.

Bill Remak, a cancer and 2X liver transplant survivor, a former scientist, nationally recognized patient and research advocate, FAIR Foundation Board Member, Board member of the California Chronic Care Coalition and Chairman of the National Association of Hepatitis Task Force is carrying the torch together with many prominent healthcare leaders and consumer advocates on this crusade. He urges people to use the new sample letter on the FAIR Foundation website to convey this important unmet need to their representatives.

The FAIR Foundation is a national non-profit organization with thousands of members and millions of supporters in all fifty states and the District of Columbia. FAIR’s Board of Directors consists of twenty-seven transplant surgeons, medical directors and patient advocates.

Remak states, “Chronic conditions that impact major segments of our society deserve a greater allocation of medical research funds. Our federal and state governments need to do better in designating medical research to prepare for better health outcomes for our workforce which will improve production and quality of life for future generations.”

Remak further clarifies, “American tax dollars fall short in providing parity and financial resources for the most devastating chronic conditions in our aging society allowing cancer, heart disease and diabetes and others to erode at every family’s economic prosperity.”

The former United Nations (WHO) World Health Organization Director, Lee Jong-wook, after exhaustive research concluded in the 2005 WHO global report the following statement which supports Remak’s claim:

“The lives of far too many people in the world are being blighted and cut short by chronic diseases such as heart disease, stroke, cancer, chronic respiratory diseases and diabetes. This is no longer only happening in high income countries. Four out of five chronic disease deaths today are in low and middle income countries. People in these countries tend to develop diseases at younger ages, suffer longer – often with preventable complications – and die sooner than those in high income countries.” Ref # 0

The same 2005 WHO report also found, in the section titled “The Urgent Need for Action,” the three top estimators of the economic impact of chronic diseases listed below. We highlight the last one as an underlying reason as to why funds should be dedicated adequately to chronic illnesses and diseases of aging for bio-medical research:

A) Chronic diseases are a major cost and a profound economic burden to individuals, their families, health systems and societies.

B) These costs will increase without the implementation of effective interventions.

C) Investment in interventions to control the burden of chronic diseases will bring appreciable economic benefits.

Wikipedia provides this well worded definition: Medical research can be divided into two general categories: the evaluation of new treatments for both safety and efficacy in what are termed clinical trials, and all other research that contributes to the development of new treatments. The latter is termed preclinical research if its goal is specifically to elaborate knowledge for the development of new therapeutic strategies. A new paradigm to biomedical research is being termed translational research, which focuses on iterative feedback loops between the basic and clinical research domains to accelerate knowledge translation from the bedside to the bench, and back again. Medical research may involve doing research on public health, biochemistry, clinical research, microbiology, physiology, oncology, surgery and research on many other non-communicable diseases such as diabetes and cardiovascular diseases.

The increased longevity of humans over the past century can be significantly attributed to advances resulting from medical research. Among the major benefits have been vaccines for measles and polio, insulin treatment for diabetes, classes of antibiotics for treating a host of maladies, medication for high blood pressure, improved treatments for hepatitis C, statins and other treatments for atherosclerosis, new surgical techniques such as microsurgery, and increasingly successful treatments for cancer. New, beneficial tests and treatments are expected as a result of the Human Genome Project. Ref #2

The journal of the American Medical Association states that in the United States the data from 2003 suggest that about 94 billion dollars were provided for biomedical research. The National Institutes of Health and pharmaceutical companies collectively contribute 26.4 billion dollars and 27.0 billion dollars, respectively, which constitute 28% and 29% of the total. Other significant contributors include biotechnology companies (17.9 billion dollars, 19% of total), medical device companies (9.2 billion dollars, 10% of total), other federal sources, state and local governments. Foundations and charities, led by the Bill and Melinda Gates Foundation, contributed about 3% of the funding. Ref #1

Recently on February 13, 2012, Francis S. Collins, M. D., Ph. D., Director of the National Institutes of Health wrote in his letter introducing the 2013 NIH Budget Plan, “In the face of growing global competition investment in biomedical and behavioral research and the scientific workforce will propel scientific discovery for the benefit of human health and the U. S. economy, both now and in the future.” Ref #3

Remak’s conclusions that disparities in research funding are negatively impacting people with chronic diseases are clearly validated by the evidence presented.

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Patients with hepatitis C virus infection who adhere to their drug regimen are more likely to show long-term benefit

Less than optimal adherence by a patient infected with hepatitis C virus (HCV) to a regimen of pegylated interferon and ribavirin decreases the likelihood of finding no detectable viral load 24 weeks after the medication is stopped (a sustained viral response), according to a new study. The standard of care for HCV infection—twice-daily treatment with oral ribavirin and weekly subcutaneous injection of pegylated interferon 2a or 2b—can eradicate the virus, halt or regress liver fibrosis, and reduce the risks for cirrhosis of the liver, hepatic decompensation, and malignant liver cancer. However, the treatment is complex and requires frequent laboratory monitoring of the viral response and possible adverse effects.

The researchers found that patients infected with HCV genotypes 1 or 4 were more likely to have an early virologic response, a 100-fold reduction in viral load, over the initial 12 weeks of treatment with 91–100 percent adherence (63 percent of 2,187 patients). This contrasted with patients with 40 percent adherence or less (37 percent of 68 patients). Patients with HCV genotypes 2 or 3 with adherence of 91–100 percent were also more likely to exhibit EVR (91 percent of 713 patients) than those with adherence of 40 percent or less (67 percent of 18 patients). For patients who showed a virologic response by 24 weeks of treatment, 47 percent of those infected with HCV genotype 1 or 4 and 69 percent of those infected with HCV genotypes 2 or 3 achieved a sustained viral response.

The researchers analyzed electronic medical record data from the National Veterans Affairs (VA) Hepatitis C Clinical Case Registry, together with medication information on these patients from the VA pharmacy database. A total of 5,706 patients treated with pegylated interferon and ribavirin were included in the study. It was funded in part by a grant (HS10399) from the Agency for Healthcare Research and Quality to the University of Pennsylvania Center for Education and Research on Therapeutics (CERT).

For more information on the CERTs program visit http://www.certs.hhs.gov.

More details are in "Relationship between adherence to hepatitis C virus therapy and virologic outcomes," by Vincent Lo Re III, M.D. M.S.C.E., Valerie Teal, M.S., A. Russell Localio, Ph.D., and others in the September 20, 2011, Annals of Internal Medicine 155(6), pp. 353–360.

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Roche improves cutting-edge portfolio for early hepatitis C diagnosis and targeted treatment

Rotkreuz, 06 March 2012

Elecsys® anti-HCV II immunoassay from Roche receives CE mark

Roche now offers a fully updated state-of-the-art portfolio for the early detection of hepatitis C virus (HCV) infection and personalized disease management. The improved diagnostics and patient monitoring solution provides an one-stop shop for HCV testing with unprecedented performance in early infection and ease of use, allowing clinicians to work efficiently and to suit individual patient treatment.¹

Early detection of HCV infection is vital in order to provide consolidated care of acute and chronic infection, and adequate treatment of drug response monitoring are crucial to overall therapy success. Patients undergoing a peginterferon alfa-2a and ribavirin therapy can be monitored precisely by real-time PCR measurement.

With the novel Elecsys anti-HCV II immunoassay on cobas® e modules Health Care Professionals get a cutting-edge tool for the early qualitative detection of antibodies against HCV. The updated assay with CE mark approval delivers enhanced convenience, specificity, increased reliability and consistency for improved efficiency in screening patients and blood donors.¹

Following the identification of HCV antibodies, testing for HCV RNA, which is a crucial marker in the management of hepatitis C, confirms the infection and aids clinicians in predicting treatment response. In December 2011, Roche also received the CE mark for its HCV RNA qualitative and quantitative tests, which offer sensitive detection of HCV RNA and viral load measurement for predicting drug response on the COBAS® AmpliPrep/COBAS® TaqMan® fully automated platform.

As Personalized Healthcare has already begun to add true medical value for health professionals and patients, Roche’s novel portfolio underlines the clear shift from an ‘equal shares for all’ principle toward a target oriented and response-guided therapy approach. Out now, the updated portfolio of HCV testing and monitoring from Roche delivers a convenient set of tools to laboratories and clinicians to improve patient care.

About hepatitis C

World Health Organization figures show that around 200 million people globally are infected with HCV, which is particularly concentrated in the blood. Around 170 million people are chronic carriers of the virus, which can lead to cirrhosis, liver failure, and hepatocellular carcinoma.² Identifying HCV infection is difficult because there are often no symptoms. Most cases go undetected and there is currently no vaccine to prevent infection. Many countries are currently unable to screen blood donations for infections such as hepatitis C.³

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2011, Roche had over 80,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 42.5 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References

1)Esteban Juan et al (2012). Elecsys anti-HCV II: a sensitive and specific assay for diagnosing hepatitis C virus (HCV) infection. In: Hepatology, Vol. 6, N° 1; Zitzer Heike et al (2011). Clinically Relevant HCV RNA Viral Load Results Using a Sensitive, Quantitative Assay. 7th European Meeting on Molecular Diagnostics, October 12-14, 2011, Scheveningen, the Netherlands
2)World Health Organization. Hepatitis C. Fact sheet N°164. Retrieved from http://www.who.int/mediacentre/factsheets/fs164/en/ on February 19, 2012.
3)World Health Organization. Blood Safety and Availability. Fact sheet N°279. Retrieved from http://www.who.int/mediacentre/factsheets/fs279/en/index.html on February 19, 2012.

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Bonnie and Charlie's Journey

by Bonnie Buckley

July 4, 2007

The day started out like any other day but wow would it ever end with a bang . When I woke up for work Charlie (hubby) was gone to work hours earlier and I went to shower and get our daughter Kayla up for highschool.Something we did on a regular daily basis. I came out of the shower and noticed Charlie was back home in bed and looked horrible sick. I got him some meds and gingerale and headed to drop Kayla at school and me at work. Kayla called me at work around 2pm when she got home from school and said her dad was terribly sick with severe stomach pains and vomiting and looked a yellowy color.This seemed to come out of nowhere but as I look back he hadn’t been well for a very long time but he wasn’t a complainer and never ever took time off work He never was sick or at least never said when he was so this was scary different. As he seldom got sick or attended an emergency department an alarm bell sounded when Kayla asked him if he would go to our local hospital to be checked out and he said yes . It was July … who has the flu in July ???? I left work early and met them at the emerg where the doc was amazing and was doing a whole slew of testing on him.One of the tests was for hepatitis C . The doc asked if he was high risk and as he had never been an IV drug user or had a blood transfusion, etc, etc, we said no but lets do the test anyway to rule this out. So we wait ……….

The doc finally came in and said Charlies blood work was not good, his liver numbers were way high and his spleen was huge and swollen very bad and other blood work was way off normal limits The doc said his assumption at that point was Leukemia or liver failure. Wow what a choice !!!! Now it was all starting to make sense …. The decade of leg muscle cramps, the headaches, the tiredness constantly, the memory issues, he couldn’t have more than 1 beer and he would be slurring his words and staggering all over the place. I always thought he was lying to me when he would say he had only had a beer or 2 at most. He had been to the family doc a few times with these complaints, not all at once but he had been there asking about the issues periodically , only to be told to drink more milk for the cramps, get more sleep for the tiredness, forgetfulness and he was under too much stress which causes headaches. Not once did she do any blood work on him !!!!! It was one of the worst nights of my life ( or at that time I thought it was but I sure didn’t forsee the nights of the future). He was referred to an internist here in Guelph the next day and I was not happy with the investigation plan so I made us an appointment with the family doctor and demanded he be sent to a large city center hospital familiar with liver issues. At this time we still didn’t know the results of the hep c test and really gave it no further thought. As we waited for the referral appointment notice to come I searched up everything I could on liver disease and leukemia. Scary stuff I remember thinking , and a lot of talk of hep c …. Hmmmmm ….. I wondered . The tests finally came back and it wasn’t leukemia but it was late stage cirrhosis of the liver and the hep c test came back positive !!!! We were shocked , what did this all mean anyway???? Well he had genotype 3b hepatitis c and now it was time to digest all this life changing information and that was a huge task. Where the heck did he get hep c from and why the heck did the family doc not diagnose this decades earlier when he had all these vague symptoms. A blood test panel would have possibly caught the wacky numbers . But we had to go forward and to play the blame game wasn’t productive as we were fighting for his life which was far more urgent. Our appointment for Charlie at London Health Sciences Hospital in London Ontario was booked for only a couple of months down the road and that was a short wait considering the wait to go see a specialist in Ontario is dismal . He was put on Furosimide for the ascites and he had to have 2 litres of fluid drained from his stomach as well . He was put on a low sodium diet to help as well with the swellings and we waited ….. It was the end of August 2007 when we first went to London to the hepatologists. He was scheduled for numerous blood tests, and ultrasound, a CT scan and was put on new medicines . They asked about the risk factors for the hep c and honestly we weren’t sure how he contracted it but I did get a feeling that they thought we were just neglecting to disclose some of his drug using past , which there was definitely some marijuana use on a regular basis but never anything snorted or injected. He had 2 tattoos that had been done in the basement of a work buddies house that were suspect but for me it didn’t matter how or where he contracted hep c …. He had it and no one deserves the suffering or stigma associated with hep c. It was a wait and see and monitor the situation approach that the docs in London decided to take. No treatment for hep c until they saw if they could stop the progression or at least slow down the liver decline. As a wife and caregiver it was heartbreaking and scary to be going through this. I watched my mother take care of my father my entire childhood as he suffered from a rare blood disorder that eventually took his life and I saw and felt the heartache and agony and here I was experiencing it all over again as a wife this time. It was awful watching such a strong, happy, wonderful man deteriorate before my eyes. I had 3 children when I first met Charlie back in 1984 and he was my friend at first , but we fell in love and I do believe we are soulmates. He adopted my 3 children as we had been abandoned by my ex husband the year prior and then we married and had our baby girl together in 1989. Life was good back then and now we were faced with this !!!

As the months passed by Charlie became weaker and sicker and spent a lot of time in bed and his memory was fading fast. I would have to explain simple things to him time and time again and it was sad and frustrating at the same time. I felt so bad for being snappy with him sometimes but he was frustrating and I have never been a very patient person. I loved him so much and it drove me crazy to see him wasting away.As his body was filling with toxins it was almost impossible to sleep in the same room with him. The odor coming from his skin was really bad and some nights I would have to sleep at the end of the bed so my head was near the open window. I felt so bad . He would sometimes say to me “do I smell that bad again?” I would tell a fib and say no he didn’t smell that bad it was just me having a hard time sleeping that night. The feelings of defeat, heartache, fear, lonliness and anger were overwhelming and I sometimes wish I would just go to sleep and never wake up, it would be easier I would tell myself, the hurt would go away finally. But then out of nowhere I would gather strength and determination to go on another day and fight with all I had to make someone help him. He couldn’t die on me I kept thinking, he cant leave me here alone. Someone must be able to fix him, this isn’t fair and Im not accepting this . His liver was failing and he was now in end stage cirrhosis of the liver by Feb of 2008 and the docs in London decided that he needed to go for a liver transplant assessment to see if he would be able to tolerate hep c treatment or if he should be placed on the transplant list right away. So we were sent home to wait for the call that would book the 4 days of ultrasounds, blood tests, CT scans, counselling appointments and psychiatric appointments. Life was hard for all of us while we waited for answers and a concrete plan , all the while watching him slip away bit by bit and helpless to do anything to make him better. This was so unfair I kept telling myself , this is nonsense, how can he be so sick , so fast at 46 years old !!!! Soon hopefully we would be London bound for the 4 day assessment and hopefully have a plan in place to make this better , at least that’s what I thought ……… The journey through the transplant assessment and ups and downs and the outcome of the process is coming up shortly … stay tuned and thanks for visiting .

Bonnie Buckley

CROI 2012: Data from Phase 2 Study of an INCIVEK® Combination Regimen Showed 74% of People Co-Infected with Hepatitis C and HIV Had Undetectable Hepatitis C Virus 12 Weeks After Treatment Ended (SVR12)

March 6, 2012
- INCIVEK was well tolerated with commonly used Atripla- and Reyataz-based HIV treatment regimens, and no patients experienced HIV breakthrough -
- Enrollment is ongoing in Phase 3 study evaluating 24- and 48-week treatment durations in people who are co-infected -
SEATTLE--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced interim results from an ongoing Phase 2 study designed to evaluate the safety and tolerability of INCIVEK^® (telaprevir) tablets in combination with pegylated-interferon and ribavirin in people who are co-infected with genotype 1 hepatitis C virus and human immunodeficiency virus (HIV). Data showed 74 percent (28/38) of patients who were treated with INCIVEK (in-SEE-veck) combination therapy had undetectable hepatitis C virus (HCV RNA) 12 weeks after the end of all study treatment (SVR12) compared to 45 percent (10/22) who were treated with pegylated-interferon and ribavirin alone. INCIVEK was well tolerated with commonly used Atripla^®- and Reyataz^®-based HIV treatment regimens. Changes in CD4 counts were similar between the treatment groups and no HIV viral load breakthroughs were observed in either treatment group during the study. The most common adverse events in the INCIVEK arms of the study were fatigue, pruritis (itching), headache, nausea and rash. No cases of severe rash were reported and there were no discontinuations due to rash. Interim results from this study are being presented at the Conference on Retroviruses and Opportunistic Infections (CROI), March 5 to 8, 2012 in Seattle.
"Hepatitis C generally progresses faster, leads to more long-term liver complications and has been harder to cure among people who also have HIV," said Robert Kauffman, M.D., Ph.D., Senior Vice President and Chief Medical Officer at Vertex. "These new INCIVEK data are important as we work toward our goal of helping cure more people with hepatitis C. We're actively enrolling co-infected patients in a Phase 3 study and expect that data from this study will be included in a submission for a supplemental approval of INCIVEK."
The Phase 2 study includes two parts: Part A is evaluating people who are not currently being treated with antiretroviral therapy (ART) for HIV infection and Part B is evaluating those who are taking an Atripla- or Reyataz-based regimen for HIV. This study enrolled patients who were new to hepatitis C treatment (treatment naïve). Patients who were randomized to receive INCIVEK were treated with 12 weeks of INCIVEK, pegylated-interferon and ribavirin, followed by 36 weeks of pegylated-interferon and ribavirin alone. Interim data also showed that 68 percent (26/38) of patients treated with INCIVEK combination therapy in this study had a rapid viral response (RVR, undetectable hepatitis C virus at week 4 of treatment) compared to none (0/22) of the patients who received pegylated-interferon and ribavirin alone.
"There is a great need for treatments that are well tolerated and offer co-infected patients a better chance at a cure for hepatitis C while maintaining suppression of their HIV," said Douglas Dieterich, M.D., Professor of Medicine in the Division of Liver Diseases, Mount Sinai School of Medicine, New York City. "It's very encouraging that nearly three out of four people had undetectable hepatitis C virus 12 weeks after stopping INCIVEK combination therapy and that their HIV medicines continued to work during treatment."
Interim Study Results
Sixty-two people 18 and older were enrolled in this Phase 2 study and 60 received at least one dose of study drug. This analysis was conducted 12 weeks after patients completed all treatment. The ART regimens evaluated in this study were selected based on current HIV treatment guidelines from the U.S. Department of Health and Human Services, International AIDS Society and drug-drug interaction studies of INCIVEK with commonly used ART medicines.

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The majority of adverse events in this study were mild or moderate. Adverse events that occurred more frequently in the INCIVEK arms compared to placebo (≥10 percent difference) were pruritis (itching), headache, nausea, rash, fever, and depression. Three patients, all in Arm B, discontinued all study treatment due to adverse events (one each due to gall stones, hemolytic anemia and nausea/vomiting).
About this Phase 2 Study
Vertex and its collaborator Janssen conducted extensive drug-drug interaction studies with INCIVEK and commonly used HIV medicines prior to initiating a development program in people co-infected with hepatitis C (HCV) and HIV. This Phase 2 study is a two-part (A and B), randomized, double-blind, placebo-controlled, parallel group, multi-center study in people chronically infected with both HCV and HIV who were new to HCV treatment. The primary endpoint of the study is to evaluate the safety and tolerability of INCIVEK combination therapy in people co-infected with HCV and HIV. A secondary endpoint is to evaluate rates of sustained viral response (SVR) 12 and 24 weeks after the end of treatment. The study is being conducted by Vertex in collaboration with Janssen.
Phase 3 Study Actively Enrolling
Enrollment is ongoing in a Phase 3 study evaluating 24- and 48-week response-guided regimens of INCIVEK combination therapy in people co-infected with HCV and HIV. Patients who are either new to treatment for HCV, or who had relapsed after at least one prior course of therapy with pegylated-interferon and ribavirin alone, will receive 24 or 48 weeks of INCIVEK combination treatment, based on their antiviral response. Patients who had not responded to a prior course of treatment (partial responders and nulls) will receive 48 weeks of INCIVEK combination treatment. A similar study is also being initiated by Janssen in its territories.
Data from In Vitro Evaluation of INCIVEK and HIV Protease Inhibitors
Also being presented at CROI this week are data from an in vitro evaluation of the anti-HIV activity of four HIV protease inhibitors (amprenavir, darunavir, lopinavir and atazanavir) in combination with INCIVEK. In the study, no antagonistic effects on the antiviral activity were observed when INCIVEK was used in combination with amprenavir, darunavir, and lopinavir, and slight antagonistic effects were observed on the antiviral activity of atazanavir.
About INCIVEK
INCIVEK ^® (telaprevir) tablets is an oral medicine that acts directly on the hepatitis C virus protease, an enzyme essential for viral replication. INCIVEK is the most prescribed direct-acting antiviral for the treatment of adults with genotype 1 chronic hepatitis C and has been used to treat more than 30,000 people in the United States.
INCIVEK was approved by the U.S. Food and Drug Administration (FDA) in May 2011 and by Health Canada in August 2011 for use in combination with pegylated-interferon and ribavirin for people with genotype 1 chronic hepatitis C with compensated liver disease (some level of damage to the liver but the liver still functions), including cirrhosis (scarring of the liver). INCIVEK is approved for people who are new to treatment, and for people who were treated previously with interferon-based treatment but who did not achieve a sustained viral response, or viral cure (relapsers, partial responders and null responders).
Vertex developed telaprevir in collaboration with Janssen and Mitsubishi Tanabe Pharma. Vertex has rights to commercialize telaprevir in North America where it is being marketed under the brand name INCIVEK (in-SEE-veck). Janssen has rights to commercialize telaprevir in Europe, South America, Australia, the Middle East and certain other countries. In September 2011, telaprevir was approved in the European Union and Switzerland. Telaprevir is known as INCIVO^® in Europe. Mitsubishi Tanabe Pharma has rights to commercialize telaprevir in Japan and certain Far East countries. In September 2011, telaprevir was approved in Japan and is known as Telavic^®.
INCIVEK^® is a registered trademark of Vertex Pharmaceuticals Incorporated.
PEGASYS^® and COPEGUS^® are registered trademarks of Hoffmann-La Roche.
Reyataz^® is a registered trademark of Bristol-Myers Squibb.
Atripla^® is a registered trademark of Bristol-Myers Squibb and Gilead Sciences, LLC.
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 can be cured.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 Hepatitis C and HIV Co-Infection
There are 1 million people living with HIV in the United States, and an estimated 300,000 people living with HIV/AIDS in the United States are also infected with hepatitis C. ¹³ There have been dramatic improvements in the treatment of HIV and the prognosis for people living with HIV. However, liver disease progresses more rapidly in people co-infected with hepatitis C and HIV, with an increased rate of progression to cirrhosis, decompensated liver disease, hepatocellular carcinoma and death. ^{14, 15, 16, 17} The hepatitis C cure rate with a 48-week treatment of pegylated-interferon and ribavirin, the current standard of care for people with co-infection, is approximately 29 percent.¹⁸
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, rheumatoid arthritis, 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. Today, Vertex has more than 2,000 employees around the world, and Science magazine named Vertex number one on its 2011 list of Top Employers in the life sciences.
Vertex's press releases are available at www.vrtx.com.
Special Note Regarding Forward-Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including Dr. Kauffman's statements in the second paragraph of this press release and statements regarding ongoing and planned Phase 3 studies of INCIVEK combination therapy in people co-infected with HCV and HIV. 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 the outcomes from future clinical trials of INCIVEK combination therapy in co-infected patients may not be favorable 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 www.vrtx.com. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.
IMPORTANT SAFETY INFORMATION
Indication
INCIVEK^® (telaprevir) 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, a patient should not take INCIVEK combination treatment if she is pregnant or may become pregnant, or if he is a man with a sexual partner who is pregnant. Patients must use two forms of effective birth control during treatment and for the 6 months after treatment with these medicines. Hormonal forms of birth control, including birth control pills, vaginal rings, implants or injections, may not work during treatment with INCIVEK.
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 patients cannot take with INCIVEK combination treatment. Patients should tell their healthcare providers about all the medicines they take, including prescription and non-prescription medicines, vitamins and herbal supplements.
INCIVEK can cause serious side effects including skin reactions, rash and anemia that can be severe. 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. Patients should tell their healthcare providers about any side effect that bothers them or doesn't go away.
Please see full Prescribing Information for INCIVEK including the Medication Guide, available at www.INCIVEK.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 February 22, 2012.
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 February 22, 2012.
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 February 22, 2012. 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.
¹³ HIV Advocate. HIV/HCV Coinfection. Available at: http://www.hcvadvocate.org/hepatitis/factsheets_pdf/HIV_HCV20coinfecton_10.pdf. Accessed February 28, 2012.
¹⁴ Martin-Carbonero L, Benhamou Y, Puoti M, Berenguer J, Mallolas J, Quereda C, et al. Incidence and predictors of severe liver fibrosis in human immunodeficiency virus-infected patients with chronic hepatitis C: a European collaborative study. CID 2004;38:128-33.
¹⁵ Martinez-Sierra C, Arizcorreta A, Diaz F, Roldan R, Martin-Herrera M, Perez- Guzman E, et al. Progression of chronic hepatitis C to liver fibrosis and cirrhosis in patients coinfected with hepatitis C virus and human immunodeficiency virus. CID 2003;36:491-8.
¹⁶ Matthews GV, Dore GJ. HIV and hepatitis C coinfection. JGH. 2008; 23: 1000-1008.
¹⁷ Bruno R, Sacchi P, Puoti M, Soriano V, Filice G. HCV chronic hepatitis in patients with HIV: clinical management issues Am J Gastroenterol 2001; 97:1598—1606.
¹⁸ Levin, J. Pegasys/RBV in APRICOT Study- Adherence Improves SVR 300% in genotype 1. Available at: http://www.natap.org/2005/ICAAC/icaac_31.htmAccessed February 28, 2012.
Vertex Pharmaceuticals Incorporated
Media:
Dawn Kalmar
Erin Emlock
Zach Barber
617-444-6992
mediainfo@vrtx.com
or
Investors:
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or
Lora Pike, 617-444-6755
Source: Vertex Pharmaceuticals Incorporated
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