FDA Approves New Combination Therapy for all Major Hepatitis C Genotypes
The U.S. Food and Drug Administration (FDA) has approved Mavyret (glecaprevir/pibrentasvir), a combination drug regimen for the treatment of patients with all major genotypes (1-6) of the chronic hepatitis C virus (HCV). The once-daily, orally-administered therapy includes two distinct antiviral agents in a fixed-dose combination of glecaprevir, an NS3/4A protease inhibitor, and pibrentasvir, an NS5A inhibitor. The regimen, which is designed to last eight weeks, does not include ribavirin. Mavyret is manufactured by AbbVie.
Included in the approval are HCV patients without cirrhosis (liver disease) or with mild cirrhosis, plus those with moderate to severe kidney disease and those who are on dialysis. The therapy is also approved for adult patients with HCV genotype 1 infection who have been previously treated with a regimen either containing an NS5A inhibitor or an NS3/4A protease inhibitor but not both.
The Mavyret approval was based in large part on safety and efficacy clinical trials which included approximately 2,300 adult patients 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% of patients who received Mavyret for eight, 12 or 16 weeks duration had no virus detected in the blood 12 weeks after finishing treatment.
“This approval provides a shorter treatment duration for many patients, and also a treatment option for certain patients with genotype 1 infection, the most common HCV genotype in the United States, who were not successfully treated with other direct-acting antiviral treatments in the past,” said Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.
Source: FDA news release dated August 3, 2017