May 13, 2011 -- The FDA today approved a new drug called Victrelis (boceprevir) to treat certain adults with chronic hepatitis C.
"Victrelis is used for patients who still have some liver function, and who either have not been previously treated with drug therapy for their hepatitis C or who have failed such treatment," an FDA news release states.
The FDA approved Victrelis for use with standard hepatitis C treatments. An FDA advisory panel recently voted to recommend the drug's approval.
The agency's approval of Victrelis is based on two studies that included 1,500 adults with hepatitis C. In those studies, in two-thirds of patients receiving Victrelis -- in combination with two standard hepatitis C drugs -- the hepatitis C virus was undetectable in their blood 24 weeks after treatment stopped.
“Victrelis is an important new advance for patients with hepatitis C. 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,” Edward Cox, MD, MPH, says in an FDA news release. Cox directs the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.
Victrelis is a pill taken three times a day with food. The therapy is part of a class of drugs referred to as protease inhibitors, which work by binding to the virus and preventing it from multiplying.
In the studies reviewed by the FDA, the most commonly reported side effects in patients receiving Victrelis included fatigue, low red blood cell count (anemia), nausea, headache, and taste distortion.
Another protease inhibitor, called telaprevir, is also up for consideration by the FDA as a treatment for Hepatitis C.