Boceprevir approved for treating hepatitis C

American Pharmacists Association News, 05/20/2011

The protease inhibitor boceprevir (Victrelis—Merck) has been approved for treating chronic hepatitis C virus (HCV) infection in adult patients with some remaining liver function and who have not been treated with medication for HCV previously or who have failed such treatment. Boceprevir's safety and effectiveness were researched via two Phase III clinical trials involving 1,500 patients.

  • According to FDA, HCV patients who sustain a virologic response after completing treatment are considered to be cured.
  • Decreased cirrhosis and liver disease complications, lower rates of liver cancer (hepatocelluar carcinoma), and decreased mortality can result if virologic response is sustained in HCV patients.
  • Boceprevir is dosed at 800 mg (four 200-mg capsules) three times a day with food and must be administered in combination with peginterferon alfa and ribavirin.
  • Adverse effects commonly reported in patients taking boceprevir, pegylated interferon, and ribavirin included fatigue, nausea, anemia, nausea, taste distortion, and headache.

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