Clinical trial results support experimental Gilead drug for hepatitis C as safe, effective, FDA records show

Documents posted on FDA site ahead of Friday's advisory committee meeting

NEW YORK — An experimental drug under development by Gilead Sciences for hepatitis C is safe and effective when combined with other treatments, according to a review posted on the Food and Drug Administration's website ahead of an expert panel meeting to take place Friday.

The FDA's Antiviral Drugs Advisory Committee will meet Friday to decide whether or not to recommend approval for sofosbuvir combined with the generic antiviral ribavirin or biotech drugs used to treat hepatitis C called interferons. Gilead is seeking FDA approval for the drug in treating patients with hepatitis C genotypes 1-4. Advisory committee votes do not guarantee whether the FDA will approve a drug, but the agency usually follows them.

According to the review, a combination of sofosbuvir with ribavirin in patients with genotypes 2 and 3 of the virus would provide the treatment consisting entirely of orally administered drugs, without interferons, as well as shorter treatment times and better safety than treatments including interferons. While effective in treating and curing hepatitis C, interferons have many side effects, including severe depression.

In addition, the review said the drug would be more effective and faster in patients with genotypes 1 and 4 when combined with interferons and ribavirin.

 

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