Mavyret Approved as 8-Week Treatment for Hep C, Compensated Cirrhosis
MONDAY, Sept. 30, 2019 -- Approval of Mavyret (glecaprevir and pibrentasvir) tablets has been expanded to eight-week treatment for treatment-naive patients aged 12 years and older with chronic hepatitis C virus (HCV) genotypes 1 through 6 and compensated cirrhosis, the U.S. Food and Drug Administration announced last week.
Mavyret is the first eight-week treatment approved for any treatment-naive HCV patients, regardless of cirrhosis status or treatment type. The drug is now approved for all treatment-naive adult patients and certain pediatric patients (weighing at least 99 pounds) without cirrhosis and with compensated cirrhosis. Standard treatment length for compensated cirrhosis was at least 12 weeks.
Approval was based on clinical trial data from more than 2,500 patients with HCV genotype 1 through 6 infection. Patients received Mavyret for eight, 12, or 16 weeks. Patients included those with HIV coinfection, kidney or liver transplant recipients, and patients with advanced kidney disease. Sustained virologic response with Mavyret at 12 weeks posttreatment ranged from 91 to 100 percent across clinical trials.
The most commonly reported adverse reactions with Mavyret were fatigue and headache. Contraindications include patients with moderate or severe liver impairment or a history of liver decompensation as well as patients taking atazanavir and rifampin.
Approval was granted to AbbVie.
© 2020 HealthDay. All rights reserved.
Posted: September 2019
Read this next
TUESDAY, Sept. 8, 2020 -- New hepatitis C medications are allowing people to receive a kidney transplant from a deceased donor who had the liver disease -- a strategy aimed at...
FRIDAY, March 20, 2020 -- Epclusa (sofosbuvir and velpatasvir) received approval for a supplemental application to treat hepatitis C virus (HCV) in children without cirrhosis or...
WEDNESDAY, March 11, 2020 -- People with hepatitis B or C are at greater risk for liver cancer, but a low-dose aspirin a day might significantly lower that risk, a new study...
More News Resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
- Monthly Update Archive
Subscribe to our Newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.