This site is intended for healthcare professionals
News

CHMP recommends approval of change of indication for Maviret in chronic hepatitis C genotype 3.- AbbVie

Read time: 1 mins
Published:1st Feb 2020
AbbVie announced that the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended a change to the marketing authorization for Maviret (glecaprevir/pibrentasvir) to shorten once-daily treatment duration from 12 to 8 weeks in treatment-naïve, compensated cirrhotic, chronic hepatitis C (HCV) patients with genotype (GT) 3 infection. Maviret is currently indicated as an 8-week, pan-genotypic (GT1-6), once-daily regimen for treatment-naïve HCV patients without cirrhosis, and as an 8-week, once-daily regimen for treatment-naïve GT 1, 2, 4, 5 and 6 HCV patients with compensated cirrhosis. If approved by the European Commission (EC), Maviret will be the only 8-week treatment option for treatment-naïve chronic HCV patients, without cirrhosis or with compensated cirrhosis, regardless of genotype.The CHMP positive opinion is supported by data from the Phase IIIb EXPEDITION-8 study, which showed that with 8 weeks of Maviret, 97.7 percent (n=335/343) of GT1- 6 patients achieved a sustained virologic response 12 weeks after treatment (SVR12) (ITT). For patients with GT3, the SVR12 rate was 95.2% (n= 60/63) (ITT). To date, one virologic failure has been reported in these patients and no patients have discontinued treatment due to adverse events. Adverse events (frequency >5%) reported in the study include pruritus (8%), fatigue (9%), headache (8%) and nausea (6%). Six serious adverse events (2%) occurred during the study, none of which were deemed to be related to glecaprevir/pibrentasvir. No new safety signals were identified in this study. The Phase IIIb EXPEDITION-8 study evaluated 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, 3, 4, 5, and 6 (n=343) patients.
Condition: Hepatitis C
Type: drug

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.