FDA Approves New Drug to Fight Hepatitis CLast Updated: May 13, 2011. Victrelis appears to clear the body of the liver-damaging virus quicker than standard medicines.
FRIDAY, May 13 (HealthDay News) -- The U.S. Food and Drug Administration late Friday gave approval to Victrelis (boceprevir), one of a new class of drugs aimed at fighting chronic hepatitis C infection.
According to The New York Times, the new drug appears to help more people clear the virus from their system in a shorter time span than older medications. In one trial sponsored by the drug's maker, Merck, 44 percent of patients were successfully treated within 28 weeks instead of the typical 48.
"Victrelis is an important new advance for patients with hepatitis C," Dr. Edward Cox, director of the Office of Antimicrobial Products in FDAs Center for Drug Evaluation and Research, said in an agency 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."
More than 3 million Americans currently have chronic infection with the hepatitis C virus, which can cause long term damage to the liver leading to liver dysfunction or failure, according to the U.S. Centers for Disease Control and Prevention. Hepatitis C is a blood-borne infection; people typically become infected via needle sharing, sharing toothbrushes or razors with someone who is infected, or sexual contact. Infants can pick up hepatitis C from an infected mother.
Hepatitis C infection is a "silent killer" because infected individuals may go for years without displaying symptoms before liver damage becomes apparent. This damage can take the form of cirrhosis, which is also tied to bleeding, jaundice and even liver cancer. According to the CDC, chronic hepatitis C infection is responsible for most of the liver transplants now conducted in the United States.
The FDA approved Victrelis -- a pill taken three times a day with food -- for use alongside two other drugs, peginterferon alfa and ribavirin. Approval came after the drug's safety and effectiveness were tested in two phase 3 trials involving 1,500 adult patients. Results from both studies show that two-thirds of patients taking the three-drug combination had a "sustained virologic response," meaning the hepatitis C virus was no longer detectable in blood tests even 6 months after treatment had ended -- an advance over the use of peginterferon and ribavirin alone.
Side effects with the three-drug regimen included anemia, nausea, headache and troubles with taste.
Victrelis, which is marketed by New Jersey-based Merck, is one of a class of drugs called protease inhibitors. These drugs work by binding with the virus and blocking its proliferation.
According to The New York Times, a second hepatitis C-targeted protease inhibitor, Vertex Pharmaceuticals' telaprevir, is also expected to win FDA approval later this month.
Find out more about hepatitis C infection at the U.S. National Library of Medicine.
SOURCES: May 13, 2011, news release, U.S. Food and Drug Administration; The New York Times
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