Mavyret Approved for Hepatitis C
August 3, 2017 – The U.S. FDA has approved Mavyret™ (glecaprevir/pibrentasvir), manufactured by AbbVie, for treatment of patients with chronic hepatitis C virus (HCV) genotype (GT) 1, 2, 3, 4, 5, or 6 either without cirrhosis, or with compensated cirrhosis. It is also indicated for treatment of adult patients with HCV GT 1 who have been previously treated with an HCV NS5A inhibitor or an NS3/4A protease inhibitor, but not both.
Mavyret consists of an NS3/4A protease inhibitor (glecaprevir) and an NS5A inhibitor (pibrentasvir). Each tablet contains 100mg of glecaprevir and 40mg of pibrentasvir. Recommended dosing is three tablets once daily with food for a period of 8, 12, or 16 weeks. Length of treatment is determined by which medications, if any, the patient has tried previously, and if the patient has compensated cirrhosis.
While Vosevi™ (sofosbuvir/velpatasvir/voxilaprevir), manufactured by Gilead, also offers pan-genotypic therapy for chronic HCV, the drug is indicated for treatment of a different population. The FDA approved Vosevi in July of 2017 for use in patients with HCV GT 1, 2, 3, 4, 5, or 6 who have been previously treated with an NS5A inhibitor, as well as for patients with HCV GT 1a or 3 who have been previously treated with a sofosbuvir-containing regimen without an NS5A inhibitor. Vosevi further differs from Mavyret in that it may be used in patients treated with both an NS5A and NS3A inhibitor, but is not approved for treatment-naïve patients.
Mavyret has already been launched.
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.