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FDA approves boceprevir for HCV genotype-1

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The FDA has approved boceprevir for the treatment of chronic hepatitis C virus genotype-1 infection combined with peginterferon alfa and ribavirin in adult patients with compensated liver disease previously untreated or who have failed previous therapy.

Data from the HCV RESPOND-2 trial and the SPRINT-2 trial suggest that the addition of boceprevir (Victrelis, Merck) to peginterferon-ribavirin treatment resulted in significantly higher rates of sustained virologic response in patients previously treated and patients with previously untreated HCV genotype-1 vs. pegylated interferon and ribavirin alone.

Edward Cox, MD, MPH

“Victrelis is an important new advance for patients with hepatitis C,” Edward Cox, MD, MPH, director of the FDA’s Office of Antimicrobial Products at 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 some patients’ hepatitis C infection compared to currently available therapy.”

Boceprevir should be taken orally three times daily with food. The most common adverse events include fatigue, anemia, nausea, headache and dysgeusia.

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