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A widely used pangenotypic combination therapy has moved closer to European approval for acute hepatitis C virus (HCV) infection, offering clinicians a new option for early-stage treatment across all genotypes.
At its May 2026 meeting, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending broadened indication for Maviret (glecaprevir/pibrentasvir, AbbVie Deutschland GmbH & Co. KG) to include acute HCV infections. The antiviral combination now addresses both acute and chronic HCV infections in adults and children from 3 years of age, offering clinicians a pangenotypic option across all disease stages.
Clinical Application
Hepatitis C can cause both acute and chronic infection, with chronic disease carrying a risk for progressive liver fibrosis, cirrhosis, hepatocellular carcinoma, and liver-related death if left untreated.
Glecaprevir/pibrentasvir combines two active compounds targeting crucial viral proteins. Glecaprevir inhibits the NS3/4A protease, while pibrentasvir blocks the NS5A protein, stopping the hepatitis C virus from replicating and spreading to new cells. The combination has activity against all six HCV genotypes.
Maviret can be obtained only with a prescription, and treatment should be started and monitored by a doctor experienced in the management of HCV infection.
Clinical Evidence for Acute HCV Use
Recent clinical evidence supports the use of glecaprevir/pibrentasvir in acute HCV infection. In the phase 3b M20-350 trial, 286 treatment-naive adults with acute HCV received glecaprevir/pibrentasvir once daily for 8 weeks. The study reported a sustained virologic response 12 weeks after treatment in 96% of patients, with a safety profile generally consistent with previous experience with the regimen.
Updated Guidance to Follow
The CHMP announcement does not identify the clinical studies supporting the acute HCV extension or provide new dosing details for the expanded indication.
Detailed recommendations on patient selection, dosing, treatment duration, and clinical use will be set out in the updated summary of product characteristics, which will be published on the EMA website in all official European Union languages after the European Commission grants the marketing authorization change.
