The Food and Drug Administration on May 13 approved boceprevir for select patients with chronic hepatitis C infection.
The agency said that the drug will be indicated for use in treating patients who have some liver function and either have not previously been treated with drug therapy or have failed previous therapy. Boceprevir (Victrelis, Merck) is a protease inhibitor and is approved for use in combination with peginterferon alfa and ribavirin, the current standard of care.
Describing boceprevir as an "important new advance," Dr. Edward Cox, director of the FDA’s Office of Antimicrobial Products said in a statement, "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."
Approval was based on two pivotal trials that showed that two-thirds of patients treated with boceprevir combined with peginterferon alfa and ribavirin had a significantly increased sustained virologic response. Such a response can lead to a decrease in cirrhosis and liver disease complications, according to the FDA.
Some 3.2 million Americans have chronic hepatitis C, the agency said, citing statistics from the Centers for Disease Control and Prevention. Hepatitis C is one of the leading causes for liver transplantation in the United States.
Boceprevir was unanimously supported for approval by an FDA advisory panel in April. The committee members said that the benefits far outweighed the risks, which include anemia. They also suggested that once boceprevir and another, similar protease inhibitor, telaprevir, were approved, that triple therapy would become the norm in treating chronic hepatitis C.
Telaprevir approval is anticipated.
The FDA said that in addition to anemia, the most commonly reported side effects with boceprevir used in combination with peginterferon and ribavirin include fatigue, nausea, headache, and taste distortion.