FDA approves Mavyret (glecaprevir/pibrentasvir), a once-daily, ribavirin-free treatment for adults with chronic hepatitis C virus .-AbbVie

AbbVie announced that the FDA approved Mavyret (glecaprevir/pibrentasvir), a once-daily, ribavirin-free treatment for adults with chronic hepatitis C virus (HCV) infection across all major genotypes (GT1-6). Mavyret is an 8-week, pan-genotypic treatment for patients without cirrhosis and who are new to treatment. Up to 95 percent of HCV patients in the U.S. may be eligible for treatment with Mavyret, including patients with compensated cirrhosis or without cirrhosis and those with limited treatment options, such as patients with chronic kidney disease (CKD). Approximately 3.4 million Americans are chronically infected with HCV. Additionally, HCV is common among people with severe CKD, with an estimated more than 500,000 people having both chronic HCV and CKD.

Mavyret was designed to deliver a cure across all major genotypes and specific treatment challenges, such as patients with severe CKD, and GT1 patients not cured by a NS5A inhibitor or a NS3/4A protease inhibitor (PI) direct-acting antiviral (DAA) treatment, but not both. Mavyret combines two new DAAs that target and inhibit proteins essential for the replication of the hepatitis C virus.

The approval of Mavyret is supported by data from nine registrational studies in AbbVie's clinical development program, which evaluated more than 2,300 patients in 27 countries across all major HCV genotypes (GT1-6) and special populations.Approval of follows an FDA-granted Breakthrough Therapy Designation for the treatment of GT1 HCV patients who were not cured with prior DAA therapy, as well as Priority Review. According to the FDA, Breakthrough Therapy Designation is intended to expedite the development and review of therapies for serious or life-threatening conditions, which may offer substantial improvement over available therapies.