On 19 December 2016, AbbVie submitted a new drug application to the U.S. Food and Drug Administration for the glecaprevir/pibrentasvir (trade name Mavyret) regimen for the treatment of all major genotypes of chronic hepatitis C. On 3 August 2017 the FDA approved the combination for hepatitis C treatment. In Europe, it was approved on 17 August 2017 for the same indication, under the trade name Maviret.
Glecaprevir is an antiviral drug used in the treatment of patients with hepatitis C virus (HCV) genotype 1-6, of special interest for the treatment of patients with chronic kidney disease also suffering from HCV.
Glecaprevir (INN) is a hepatitis C virus (HCV) nonstructural (NS) protein 3/4A protease inhibitor that was identified jointly by AbbVie and Enanta Pharmaceuticals. It is being developed as a treatment of chronic hepatitis C infection in co-formulation with an HCV NS5A inhibitor pibrentasvir. Together they demonstrated potent antiviral activity against major HCV genotypes and high barriers to resistance in vitro.
The most common adverse effects, observed in at least 10% of phase 3 trial participants, were headache and fatigue.
