Advisory Panel Unanimously in Favor of Boceprevir for HCV

Emma Hitt, PhD

April 29, 2011

April 29, 2011 — Boceprevir (Victrelis, Merck) received unanimous approval from participants in the Antiviral Drugs Advisory Committee meeting, who voted 18 to 0 that it should receive US Food and Drug Administration (FDA) approval for the treatment of chronic hepatitis C virus (HCV) infection.

On the first day of the meeting, held April 27 and 28, panelists considered the efficacy and safety data for boceprevir, which, if approved, will be administered at a dose of 800 mg 3 times a day, every 7 to 9 hours, with food. Boceprevir will be indicated for the treatment of patients with chronic HCV genotype 1 infection in combination with current standard therapy.

Panelists reviewed clinical trial data for boceprevir from the HCV SPRINT-2 trial in previously untreated patients and from the HCV RESPOND-2 trial in previously treated patients. Together, the trials included approximately 1500 patients with chronic HCV genotype 1 infection — the most difficult to treat and most prevalent form of HCV in the United States. Results from these studies were published in the March 31 issue of the New England Journal of Medicine and reported by Medscape Medical News.

Boceprevir, when added to peginterferon-alfa-2b and ribavirin for up to 44 weeks of therapy, resulted in a significant increase in efficacy of the standard-of-care regimen, based on sustained virologic responses, in both of the phase 3 studies.

Adverse events reported with boceprevir that occurred in more than 20% of patients included anemia (49%) and dysgeusia (37%) compared with 29% and 15%, respectively, in those treated with the peginterferon-ribavirin combination alone.

Panelists spoke in favorable terms about boceprevir, describing it as a "tremendous advance" in the treatment of patients with HCV.

"To go to a 60% or 70% sustained response really seems like a dream come true," committee member Lawrence S. Friedman, MD, from the Newton-Wellesley Hospital in Newton, Massachusetts, said during the meeting.

However, panelists and other participants also emphasized that postmarketing studies are needed to evaluate interaction with other drugs, such as serotonin reuptake inhibitors, and also to study the drug's efficacy in specific settings, such as in the elderly and in liver transplant recipients.

"The effect of boceprevir on methadone and buprenorphine in particular is one of the more important areas for study, especially since most new infections in the [United States] are related to injection drug use," said a patient representative during the open public hearing session.

"I really would love to see better education programs from the companies and the FDA...not just about resistance, but also about adherence," said participant Jules Levin, the executive director of the National AIDS Treatment Advocacy Project.

The FDA usually, but not always, follows the recommendations of its advisory panels. The FDA is expected to make a decision about boceprevir in mid-May, according to the manufacturer.

On April 28, the same panel reviewed data on telaprevir — another HCV protease inhibitor being evaluated as a treatment for chronic hepatitis C.

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