FDA approves glecaprevir-pibrentasvir for HCV – APhA submits compounding comments to FDA. – (866) 348-2889
FDA approved on Thursday glecaprevir–pibrentasvir (Mavyret—AbbVie) for the treatment of 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 who are on dialysis. The combination drug 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. This is the first treatment of 8 weeks duration approved for all HCV genotypes 1-6 in adults without cirrhosis who have not been previously treated. The standard treatment length was previously 12 weeks or more. “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 FDA’s Center for Drug Evaluation and Research. Clinical trials involving about 2,300 adults with HCV genotype 1, 2, 3, 4, 5, or 6 without cirrhosis or with mild cirrhosis found that 92%–100% of patients who received glecaprevir–pibrentasvir for 8, 12, or 16 weeks duration had no detectable virus in their blood 12 weeks after treatment completion.