Regulatory

Gilead's hepatitis C drug sofosbuvir safe, effective: FDA reviewers

Last Updated: 2013-10-23 12:32:09 -0400 (Reuters Health)

By Toni Clarke

(Reuters) - Sofosbuvir from Gilead Sciences is safe and effective when used in combination with other therapies to treat hepatitis C, according to reviewers with the U.S. Food and Drug Administration.

Their review was posted on the FDA website on Wednesday ahead of an October 25 meeting of an outside panel of medical experts who will recommend whether or not the agency should approve the drug.

"The currently available data support a favorable benefit-risk assessment for the use of sofosbuvir as part of a combination regimen for the treatment of chronic hepatitis C," the reviewers said.

"No major safety issues associated with sofosbuvir use have been identified to date."

Gilead is seeking approval to market the drug in combination with ribavirin for patients with HCV genotype 2 and genotype 3, and for patients awaiting a liver transplant.

If approved, this would be the first all-oral treatment for genotypes 2 and 3. Current therapies typically include oral ribavirin and the once-weekly injectable drug interferon. Both can cause debilitating side effects.

Gilead is also seeking to market sofosbuvir in combination with ribavirin and interferon for patients with genotype 1, regardless of prior treatments, and for patients with genotypes 4, 5 and 6 who have not previously been treated.

Chronic hepatitis C affects at least 3 million people in the United States, according to the U.S. Centers for Disease Control. HCV genotype 1 is the most common form, accounting for about 70% of cases.

Current standard treatments for genotype 1 often include an oral protease inhibitor, such as boceprevir (Victrelis, Merck) and telaprevir (Incivek, Vertex).