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# FDA Approves Gileads Vosevi for Hepatitis C
- URL: https://www.fdaweb.com/fda-approves-gileads-vosevi-for-hepatitis-c/
- Published: 2017-07-18T12:00:00.000Z
- Updated: 2026-09-14T22:34:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139159

FDA has approved Gilead’s Vosevi (sofosbuvir/velpatasvir/voxilaprevir) to treat adults with chronic hepatitis C virus genotypes 1-6 without cirrhosis or with mild cirrhosis. An agency [news release](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm567467.htm?ref=fdaweb.com) says Vosevi is a fixed-dose, combination tablet containing two previously approved drugs (sofosbuvir and velpatasvir) and a new drug (voxilaprevir). It is the first treatment approved for patients who have been previously treated with the direct-acting antiviral drug sofosbuvir or other hepatitis C drugs that inhibit a protein called NS5A, FDA says.

Vosevi’s safety and efficacy were evaluated in two Phase 3 trials involving about 750 adults without cirrhosis or with mild cirrhosis.

The agency says the results of both trials demonstrated that 96-97% of patients who received Vosevi had no virus detected in the blood 12 weeks after finishing treatment, suggesting that patients’ infections had been cured. The most common adverse reactions in patients taking the drug were headache, fatigue, diarrhea, and nausea.

FDA says that treatment recommendations for Vosevi differ depending on viral genotype and prior treatment history.