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

AbbVie has announced that the European Commission has granted marketing authorization for Maviret (glecaprevir/pibrentasvir), a once-daily, ribavirin-free treatment for adults with chronic hepatitis C virus (HCV) infection across all major genotypes (GT1-6). Maviret is a new 8-week, pan-genotypic treatment for patients without cirrhosis and who are new to treatment, who comprise the majority of the 71 million people living with HCV globally.

Maviret is also indicated for patients with specific treatment challenges, including those with compensated cirrhosis across all major genotypes, and those who previously had limited treatment options, such as patients with severe chronic kidney disease (CKD) or those with genotype 3 (GT3) chronic HCV infection.Maviret is a pan-genotypic treatment approved for use in patients across all stages of CKD. The approval of Maviret is supported by data from eight 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.

Authorization is supported by 97.5 percent (n=779/799) cure rate with just 8 weeks of treatment in GT1-6 patients without cirrhosis and who were new to treatment. This high cure rate was achieved in patients with varied patient and viral characteristics and including those with CKD. For compensated cirrhotic patients, a 98 percent (n=201/205)� cure rate was achieved with 12 weeks of treatment. For GT3 treatment-experienced patients with or without compensated cirrhosis, a 96 percent (n=66/69) cure rate was achieved with 16 weeks of treatment. In registrational studies for Maviret, less than 0.1 percent of patients discontinued treatment due to adverse reactions. The most commonly reported adverse reactions (incidence greater than or equal to 10 percent) were headache and fatigue.