EU Marketing Authorisation change for Maviret

The European Commission has granted AbbVie permission to change the Marketing Authorisation for Maviret (glecaprevir/pibrentasvir) to eight weeks of treatment.

The authorisation shortens the treatment period from from 12 to eight weeks in treatment-naïve, compensated cirrhotic, chronic hepatitis C (HCV) patients with genotype (GT) 3 infection.

Before the decision, the drug was already indicated as an eight-week, pan-genotypic (GT1-6), once-daily regimen for treatment-naïve HCV patients without cirrhosis, and as an eight-week, once-daily regimen for treatment-naïve GT 1, 2, 4, 5 and 6 HCV patients with compensated cirrhosis.

The European Commission says that the approval is supported by the Phase IIIb EXPEDITION-8 study, in which 97.7% of patients achieved a sustained virologic response 12 weeks after treatment when dosed for eight weeks.

A shorter treatment duration means that "more patients with HCV can be treated with an eight-week course of Maviret in the absence of initial tests to determine their genotype or degree of fibrosis or cirrhosis," said Janet Hammond, vice president, general medicine and virology therapeutic area, AbbVie.

She continued, "The ability to streamline pre-treatment assessment for people with HCV represents a paradigm shift in the way the disease is treated, potentially accelerating the care cascade and allowing us to make greater strides towards achieving the World Health Organisation's goal of eliminating HCV by 2030."

In Europe, 14 million people are estimated to be chronically infected with the hepatitis C virus, and many of them are unaware that they are infected. Each year 112,500 people die from hepatitis C-related liver disease.

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