The European Commission has approved glecaprevir/pibrentasvir (Maviret) for acute hepatitis C virus (HCV) infection, making it the only therapy approved in the European Union for both acute and chronic HCV and allowing clinicians to test and treat patients at the point of diagnosis. Mudra Kapoor, MD, discusses the phase 3 data and the treatment's potential role for greater HCV elimination.
In June, the European Commission approved glecaprevir/pibrentasvir (Maviret) for acute
The approval is supported by data from the phase 3 M20-350 trial, a multicenter, single-arm study of an eight-week Maviret regimen in adults with acute HCV infection.² The trial met its primary endpoint, with 96.2% of patients in the intent-to-treat population achieving sustained virologic response at 12 weeks, with no virologic failures or post-treatment relapses.²
"The data are quite encouraging…The efficacy of Maviret in curing HCV within eight weeks is very strong, and it reinforces all the data we've seen in our previous trials," said Mudra Kapoor, MD, vice president, Global Neuroscience, Eye Care & Specialty, Value + Impact Office, Medical Affairs + Health Impact AbbVie.
Along with persistent stigma and clinical inertia around testing, one of the biggest obstacles to HCV elimination is the loss to follow-up between diagnosis and treatment remains.
The EU approval lets clinicians initiate treatment immediately after diagnosis, regardless of how long a patient has been infected, removing a barrier that previously required providers to establish chronicity before treating.¹ Glecaprevir/pibrentasvir was already approved in the EU for chronic HCV infection in adults and children aged 3 years and older.²
"Now you stop the transmission by treating on the spot; preventing people from going on to develop liver cancer, liver failure, and liver cirrhosis," said Kapoor.
This is the first episode in a 2-part series. In the
