Eight-Week Hepatitis C Regimen Gets FDA Approval

Today, the FDA approved Mavyret (glecaprevir/pibrentasvir) to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis or with mild cirrhosis, including patients with moderate-to-severe kidney disease and those on dialysis.

Mavyret is also approved for adults with HCV genotype 1 previously treated with a regimen containing an NS5A inhibitor or an NS3/4A protease inhibitor, according to a press release.

“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,” Edward Cox, MD, director of Antimicrobial Products at the FDA Center for Drug Evaluation and Research, said in the release.

The approval was based on safety and efficacy data from clinical trials of approximately 2300 adults with genotypes 1-6 HCV infection without cirrhosis or with mild cirrhosis.

The results of the study showed 92% to 100% of patients who received Mavyret for an 8, 12, or 16-week duration had no virus detected in the blood 12 weeks after treatment ended. Treatment duration differs depending on a patient’s treatment history, viral genotype, and cirrhosis status, according to the release.

The most common adverse events were headache, fatigue, and nausea.

Mavyret is the first 8-week treatment regimen approved for all HCV genotypes 1-6 in treatment-naïve adults without cirrhosis, according to the release. Standard treatment length was previously 12 weeks or more.