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Gilead’s Hep C Drug Safe

By on October 23, 2013

Gilead Sciences Inc’s sofosbuvir drug 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.

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

“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 an existing treatment, ribavirin, for patients with two variants of the liver-damaging disease: genotype 2 and genotype 3, and for patients awaiting a liver transplant.

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