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.
More information
Find out more about hepatitis C infection at the
U.S. National Library of Medicine.