New Hepatitis C Drug Close to Gaining FDA Approval

Boceprevir, a new medication from Merck & Co. that changes the way hepatitis C is treated, won unanimous support Wednesday from a panel of experts convened by the U.S. Food and Drug Administration.

The drug is one of two new medications against hepatitis C that are up for agency approval. Many experts believe that, if approved, boceprevir and the second medicine, telaprevir, could revolutionize treatment of hepatitis C-linked disease.

The U.S. Centers for Disease Control and Prevention estimated 17,000 new hepatitis C virus infections in the United States in 2007. Many people with the disease have no symptoms until it has caused liver damage, sometimes so severe that a liver transplant is needed.

Studies found that when used with two older drugs, boceprevir reduced levels of the virus more effectively than the existing treatments. Merck, headquartered in Whitehouse Station, N.J., hopes to sell the medication under the brand name Victrelis, according to Dow Jones.

Telaprevir, a similar drug made by Vertex Pharmaceuticals of Cambridge, Mass., is scheduled for review Thursday by the same panel of non-FDA experts.

Debra Birnkrant, director of FDA's antiviral-drugs division, said that both medications appear to increase the cure rate "to more than 30 percent above what we have today," Dow Jones reported.

The new drugs take treatment of hepatitis C in a new direction. Both boceprevir and telaprevir block protease, an enzyme that helps the virus reproduce. The earlier drugs, pegylated interferon and ribavirin, were meant to boost the immune system's defense against the virus. Together, the combined medications may offer new hope for the thousands of Americans with the contagious liver disease.

Asked if the available data supported use of boceprevir in combination with standard treatment of pegylated interferon and ribavirin, the panel of medical experts voted 18-0 in favor, Dow Jones reported. This is considered a recommendation to approve the drug.

Although FDA does not have to follow the panel's advice, it usually does.

One of the boceprevir studies found it effective for 66 percent of patients taking the three-drug regimen compared to 38 percent of those who received the standard two-drug treatment, Dow Jones said.

Some concerns still need to be addressed, including how to treat black patients, for whom the drugs seem to be less effective.

Studies submitted by the manufacturers showed the new drugs, when added to existing treatments, shortened the length of medication therapy, thereby reducing potential side effects. Patients currently require nearly 12 months of treatment.

Telaprevir's cure rates appear to be better than boceprevir's, the Associated Press reported.

Until the early 1990s, when testing of the nation's blood supply became routine, hepatitis C was often contracted from blood transfusions. Today it is most commonly associated with injection drug use. It is also transmitted through sexual contact with an infected person, the CDC said.

Earlier this year, a study from the Johns Hopkins School of Public Health called for greater efforts to reduce the population of hepatitis C-infected injection drug users. That study found that new cases of hepatitis C were decreasing only among younger injection drug users who had recently starting using the drugs.

Source: Health Advise Source