AbbVie's MAVIRET? (glecaprevir/pibrentasvir) Approved by European Commission to Shorten Treatment Duration to Eight Weeks for Treatment-Na?ve Patients with Chronic Hepatitis C and Compensated Cirrhosis

發(fā)布時間： 2019-08-05 閱讀：1061次

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ORTH CHICAGO, Illinois, Aug. 2, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the European Commission has granted marketing authorization for MAVIRET? (glecaprevir/pibrentasvir) to shorten once-daily treatment duration from 12 to 8 weeks in treatment-na?ve, 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-na?ve, compensated cirrhotic, GT3 HCV patients is ongoing. MAVIRET is also currently approved as an 8-week, pan-genotypic (GT1-6) treatment for treatment-na?ve patients without cirrhosis.2**

The marketing authorization 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).1 To date, no virologic failures have been reported in these patients and no patients have discontinued treatment due to adverse events.1 Adverse events (frequency >5%) reported in the study include pruritus (9.6%), fatigue (8.6%), headache (8.2%) and nausea (6.4%).1 Six serious adverse events (2%) have occurred during the study, none of which were deemed to be related to glecaprevir/pibrentasvir.1 No new safety signals were identified in this study.1 These data were presented as a late-breaking, oral presentation at The Liver Meeting? 2018 organized by the American Association for the Study of Liver Diseases (AASLD) in San Francisco, California.

The ongoing Phase 3b EXPEDITION-8 study is evaluating the safety and efficacy of MAVIRET in treatment-na?ve chronic HCV patients with compensated cirrhosis across all major genotypes (GT1-6).1 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.

"There are still a significant number of HCV patients with varied patient and viral characteristics who are in need of options," said Stefan Zeuzem, M.D., chief of the department of medicine at the J.W. Goethe University Hospital in Frankfurt, Germany. "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."