Vosevi Approved for Hepatitis C
July 18, 2017 – The U.S. FDA has approved Vosevi™ (sofosbuvir 400mg/velpatasvir 100mg/voxilaprevir 100mg), manufactured by Gilead, for the re-treatment of chronic hepatitis C virus (HCV) infection in adults with genotypes 1, 2, 3, 4, 5, or 6 who have been previously treated with an NS5A inhibitor-containing regimen. Vosevi has also been approved for use in adults who have chronic HCV with genotype 1a or 3 and have been previously treated with a sofosbuvir-containing regimen without an NS5A inhibitor.
Vosevi contains sofosbuvir, a nucleotide analog polymerase inhibitor; velpatasvir, an NS5A inhibitor; and voxilaprevir, a protease inhibitor. Recommended dosing is one tablet once daily for 12 weeks. Gilead plans to have launched Vosevi by July 24, 2017.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.