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Vosevi Approval History

FDA Approved: Yes (First approved July 18, 2017)
Brand name: Vosevi
Generic name: sofosbuvir, velpatasvir and voxilaprevir
Dosage form: Tablets
Company: Gilead Sciences, Inc.
Treatment for: Hepatitis C

Vosevi (sofosbuvir, velpatasvir and voxilaprevir or SOF/VEL/VOX) is a fixed-dose combination of a nucleotide analog NS5B polymerase inhibitor (SOF), a pangenotypic NS5A inhibitor (VEL), and a pangenotypic NS3/4A protease inhibitor (VOX) for the treatment of genotype 1-6 chronic hepatitis C virus (HCV) infection.

Vosevi is indicated for the treatment of adult patients with chronic HCV infection without cirrhosis or with compensated cirrhosis (Child-Pugh A) who have:
  • genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an HCV regimen containing an NS5A inhibitor.
  • genotype 1a or 3 infection and have previously been treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor.

Development History and FDA Approval Process for Vosevi

Jul 18, 2017Approval FDA Approves Vosevi (sofosbuvir/velpatasvir/voxilaprevir) for Re-Treatment of Adults with Chronic Hepatitis C Virus
Dec  8, 2016Gilead Submits NDA to FDA for the Investigational Single Tablet Regimen Sofosbuvir/Velpatasvir/Voxilaprevir
Oct 20, 2016Gilead Announces SVR12 Rates From Four Phase 3 Studies of a Once-Daily, Fixed-Dose Combination of Sofosbuvir, Velpatasvir and Voxilaprevir

Further information

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