EU approves AbbVie’s Maviret for acute hepatitis C, expanding use beyond chronic infection

Edited by Robert McTiernan··2 min read

The European Commission has approved Maviret (glecaprevir/pibrentasvir) for the treatment of acute hepatitis C virus (HCV) infection, making it the only therapy in the EU authorized for both acute and chronic HCV. The label expansion, granted to AbbVie, covers adults and children aged 3 years and older without cirrhosis or with compensated cirrhosis. The clinical significance lies partly in timing: acute HCV is frequently asymptomatic, meaning patients are often diagnosed incidentally and may progress to chronic infection before treatment begins. Enabling treatment at the acute stage could reduce onward transmission and limit long-term liver complications.

Maviret combines two direct-acting antivirals: glecaprevir, an NS3/4A protease inhibitor discovered by Massachusetts-based Enanta Pharmaceuticals (Nasdaq: ENTA) under a collaboration with AbbVie that dates back to 2006, and pibrentasvir, an NS5A inhibitor. Together, they target distinct steps in viral replication, providing pangenotypic activity across all major HCV genotypes. The approved regimen is administered as an oral, once-daily fixed-dose combination for eight weeks.

The approval was supported by the Phase III M20-350 study (NCT04903626), a multicenter, single-arm prospective trial enrolling 286 treatment-naïve adults with acute HCV infection across 70 sites globally. The primary endpoint was sustained virological response 12 weeks post-treatment (SVR12) in the intent-to-treat population. SVR12 was achieved in 96.2% of patients (p<0.0001); in the modified intent-to-treat virologic failure population, 100% achieved SVR12. No on-treatment virologic failures or post-treatment relapses were reported, and the safety profile was consistent with that observed in chronic HCV studies.

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By inhibiting both NS3/4A protease and NS5A — proteins essential for viral polyprotein processing and replication complex assembly — the combination exerts complementary pressure on the virus, reducing the likelihood of resistance emergence. The pangenotypic profile is particularly relevant in the acute setting, where genotype testing may not yet be available at the time of diagnosis.

Although direct-acting antivirals have transformed chronic HCV treatment, uncertainty around whether and when to treat acute infection has historically led some clinicians to defer therapy until chronic infection is established. The new indication formally supports treatment earlier in the disease course. Maviret was already approved in the EU for chronic HCV and faces competition from sofosbuvir-based regimens, including sofosbuvir/velpatasvir (Epclusa, Gilead Sciences), which also carries pangenotypic activity but does not hold an EU approval specifically for acute HCV infection. The new indication therefore establishes a differentiated position for Maviret in the acute treatment setting, where earlier intervention is increasingly supported by clinical guidelines from the European Association for the Study of the Liver.

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