The FDA has approved boceprevir (Victrelis, Merck) to be used in combination with peginterferon alfa and ribavirin to treat patients with chronic hepatitis C virus (HCV) infection.
Boceprevir is the first HCV protease inhibitor to reach market and will provide a new treatment option for patients with HCV that have failed previous treatment, as well as those who have yet to receive drug therapy.
“Victrelis is an important new advance for patients with hepatitis C,” Edward Cox, MD, MPH, director of the FDA’s Office of Antimicrobial Products in the Center for Drug Evaluation and Research, said in a press release. “This new medication provides an effective treatment for a serious disease, and offers a greater chance of cure for so me patients’ hepatitis C infection compared to currently available therapy.”
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The approval comes after the Antivirals Drug Advisory Committee voted unanimously at a meeting in April that the drug was safe and effective after reviewing data from two clinical trials.
Sustained virological response rates among patients with the difficult to treat HCV genotype 1 were 67% vs. about 40% among patients assigned to the standard regimen of pegylated interferon injections and ribavirin pills. Common adverse events include fatigue, anemia, nausea, headache and dysgeusia.
The FDA is expected to approve a second protease inhibitor, telaprevir (Vertex Pharmaceuticals), for the same indication later this month.
