General Information

Mavyret is a fixed-dose combination of glecaprevir, a hepatitis C virus (HCV) NS3/4A protease inhibitor, and pibrentasvir, an HCV NS5A inhibitor.

Mavyret is specifically indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A). Mavyret is also indicated for the treatment of adult patients with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both. In addition, Mavyret has been approved for all six strains of hepatitis C in children ages 12 to 17 years. The FDA expanded the approval of Mavyret tablets in September of 2019 to include an eight-week duration for the treatment of adults and children ages 12 years and older or weighing at least 99 pounds who have chronic HCV genotype 1, 2, 3, 4, 5 or 6 infection and compensated cirrhosis and have not been previously treated for HCV (treatment-naïve).

Mavyret is supplied as a tablet for oral administration. Mavyret is a fixed-dose combination product containing glecaprevir 100 mg and pibrentasvir 40 mg in each tablet. The recommended oral dosage is three tablets (total daily dose: glecaprevir 300 mg and pibrentasvir 120 mg) taken once daily with food. Please see the drug label for drug duration based on the patient population in HCV mono-infected and HCV/HIV-1 co-infected patients with compensated liver disease (with or without cirrhosis) and with or without renal impairment including patients receiving dialysis.

Clinical Results

FDA Approval

The FDA approval of Mavyret was based on clinical trials enrolling approximately 2,300 adults with genotype 1, 2, 3, 4, 5 or 6 HCV infection without cirrhosis or with mild cirrhosis. Results of the trials demonstrated that 92-100 percent of patients who received Mavyret for eight, 12 or 16 weeks duration had no virus detected in the blood 12 weeks after finishing treatment, for an overall 98 percent cure rate. A 97.5% (n=779/799) cure rate was reported with 8 weeks of treatment in GT1-6 patients without cirrhosis and who were new to treatment. This cure rate was achieved in patients with varied patient and viral characteristics and including those with CKD. For compensated cirrhotic patients, a 98% (n=201/205) cure rate was achieved with 12 weeks of treatment. For GT3 treatment-experienced patients with or without compensated cirrhosis, a 96% (n=66/69) cure rate was achieved with 16 weeks of treatment.

The FDA approval of Mavyret for use in pediatrics was based on clinical trials of 47 pediatric patients with genotype 1, 2, 3 or 4 HCV infection who didn’t have cirrhosis or had mild cirrhosis. In the studies, all patients who received Mavyret for 8 or 16 weeks showed no detectable virus in their blood 12 weeks after completion of treatment, hence reaching clinical cure.