FDA News

FDA approves Mavyret, the first pan-genotypic 8-week treatment for HCV

The FDA approved AbbVie’s Mavyret to treat adults with hepatitis C genotypes 1 through 6 without cirrhosis or with mild cirrhosis, including those who failed previous direct-acting antiviral treatment, according to an agency press release. The new approval indicates only 8 weeks of treatment needed in treatment-naive patients without cirrhosis.

“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 the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, wrote in the release.

Mavyret (glecaprevir/pibrentasvir, AbbVie) clinical trials comprised approximately 2,300 adults with genotypes 1 through 6 without cirrhosis or with mild cirrhosis. Results demonstrated a 92% to 100% rate of sustained virologic response among the cohort.

The FDA announced approval for Mavyret for patients with HCV genotype 1 previously treated with either an NS5A inhibitor or an NS3/4A protease inhibitor. It is not approved for patients who have previously failed both treatments.

Treatment duration differed depending on treatment history, genotype and cirrhosis status. The most common adverse events were headache, fatigue and nausea. Mavyret is contraindicated for patients receiving atazanavir and Rifadin (rifampin, Sanofi) as well as those with advanced cirrhosis. Hepatitis B reactivation has been reported in patients with HCV/HBV coinfection and the FDA reminded practitioners to screen patients for HBV prior to using Mavyret to treat HCV.

Reference: www.fda.gov

The FDA approved AbbVie’s Mavyret to treat adults with hepatitis C genotypes 1 through 6 without cirrhosis or with mild cirrhosis, including those who failed previous direct-acting antiviral treatment, according to an agency press release. The new approval indicates only 8 weeks of treatment needed in treatment-naive patients without cirrhosis.

“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 the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, wrote in the release.

Mavyret (glecaprevir/pibrentasvir, AbbVie) clinical trials comprised approximately 2,300 adults with genotypes 1 through 6 without cirrhosis or with mild cirrhosis. Results demonstrated a 92% to 100% rate of sustained virologic response among the cohort.

The FDA announced approval for Mavyret for patients with HCV genotype 1 previously treated with either an NS5A inhibitor or an NS3/4A protease inhibitor. It is not approved for patients who have previously failed both treatments.

Treatment duration differed depending on treatment history, genotype and cirrhosis status. The most common adverse events were headache, fatigue and nausea. Mavyret is contraindicated for patients receiving atazanavir and Rifadin (rifampin, Sanofi) as well as those with advanced cirrhosis. Hepatitis B reactivation has been reported in patients with HCV/HBV coinfection and the FDA reminded practitioners to screen patients for HBV prior to using Mavyret to treat HCV.

Reference: www.fda.gov