FDA Approves Hepatitis C Drug
Officials with the FDA have announced the approval of glecaprevir and pibrentasvir (Mavyret, AbbVie Inc) for hepatitis C.
Officials with the FDA have announced the approval of glecaprevir and pibrentasvir (Mavyret, AbbVie Inc) for hepatitis C, according to a press release. The drug is indicated to treat adult patients with chronic hepatitis C (HCV) genotypes 1-6 without cirrhosis or with mild cirrhosis, including patients with moderate-to-severe kidney disease and those who are on dialysis.
Mavyret is also indicated to treat 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 drug’s 8-week treatment duration makes it the first drug for all HCV genotypes to be approved for a shorter treatment duration. Standard treatment length was previously 12 weeks or more.
The approval is based on clinical trials involving approximately 2300 participants with genotypes 1-6 of HCV infection, without cirrhosis or with mild cirrhosis. The results of the trial demonstrated that 92% to 100% of patients who received the treatment for 8, 12, or 16 weeks had no virus detected in the blood 12 weeks after finishing the treatment.
Treatment duration for patients taking Mavyret depend on treatment history, viral genotype, and cirrhosis status. The drug is not recommended in patents with moderate cirrhosis and contraindicated in patients with severe cirrhosis.
The most commonly reported adverse effects included headache, fatigue, and nausea.
FDA approves Mavyret for Hepatitis C [ news release]. FDA’s website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm570038.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed August 3, 2017.