Fri May 13, 2011
New drug to treat hepatitis C approved by FDA
The FDA has approved a new drug for the treatment of hepatitis C, a viral disease that attacks the liver and can lead to cirrhosis and liver cancer.
In the U.S., existing medications cure only about 50 percent of patients.
Dr. Bruce Bacon of Saint Louis University led a clinical trial for the new drug, boceprevir.
Bacon says adding boceprevir to the standard two-drug treatment significantly improved cure rates, especially for patients who have been treated before and failed to recover.
Most Americans with hepatitis C have what's known as the genotype 1 form of the virus.
"The numbers are more like 20 percent with the standard therapy being retreated versus about 60 to 65 percent cure rate with the addition of boceprevir," Bacon said, referring to people with genotype 1.
A similar drug, telaprevir, is expected to get FDA approval by the end of the month.
Dr. Adrian Di Bisceglie, also from Saint Louis University, helped test how patients responded when telaprevir was added to the current two-drug treatment.
“In a treatment regimen that has telaprevir, the cure rates or rates of sustained virologic response go from the 40 percent number that I mentioned in patients with genotype 1, to 75 percent,” Di Bisceglie said.
Both boceprevir (trade name Victrelis, by Merck) and telaprevir (trade name Incivek, by Vertex) are expected on the market in June.
According to the Centers for Disease Control and Prevention, more than three million Americans have hepatitis C, and about three-quarters of them don't know they have it.