AbbVie, has announced that the European Commission has granted marketing authorisation for MAVIRET™ (glecaprevir/pibrentasvir) to shorten once-daily treatment duration.
The once-daily treatment duration is from 12 to 8 weeks in treatment-naïve, compensated cirrhotic, chronic hepatitis C (HCV) patients with genotype (GT)1, 2, 4, 5, and 6 infection.
An analysis from the same clinical trial evaluating MAVIRET™ as an 8-week, once-daily treatment option for treatment-naïve, compensated cirrhotic, GT3 HCV patients is ongoing. MAVIRET™ is also currently approved as an 8-week, pan-genotypic (GT1-6) treatment for treatment-naïve patients without cirrhosis.
The marketing authorisation is supported by data from the ongoing Phase 3b EXPEDITION-8 study, which showed that with 8 weeks of MAVIRET™, 97.9 percent (n=274/280) of GT1, 2, 4, 5 and 6 patients achieved a sustained virologic response 12 weeks after treatment (SVR12) (ITT). To date, no virologic failures have been reported in these patients and no patients have discontinued treatment due to adverse events.
The ongoing Phase 3b EXPEDITION-8 study is evaluating the safety and efficacy of MAVIRET™ in treatment-naïve chronic HCV patients with compensated cirrhosis across all major genotypes (GT1-6). The results have been reported for GT1, 2, 4, 5, and 6 (n=280) patients. Enrollment and treatment of the GT3 patient population was completed later, therefore the analysis of this population is ongoing.
Janet Hammond M.D., vice president, general medicine and virology therapeutic area, AbbVie said,”MAVIRET™ has already had a significant impact on the lives of hundreds of thousands of people affected by chronic HCV, and with this approval, we are one step closer to providing more HCV patients with an option to treat their chronic disease with a once-daily, 8-week regimen.”
Stefan Zeuzem, M.D., chief of the department of medicine at the J.W. Goethe University Hospital in Frankfurt, Germany said, “There are still a significant number of HCV patients with varied patient and viral characteristics who are in need of options. We are working hard to help support achieving the World Health Organization’s goal of eliminating HCV by 2030 and having additional patient populations eligible for shorter-term, 8-week treatment options could help bring us closer to that goal.”