MAVIRET Earns Marketing Authorization in Europe for HCV Treatment

The European Commission has granted marketing authorization for AbbVie’s glecaprevir/pibrentasvir (MAVIRET), a treatment for adults with chronic hepatitis C virus (HCV) infection across all major genotypes (GT1-6).

The marketing authorization follows a positive June 23 recommendation from the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP).

MAVIRET is a once-daily, ribavirin-free, 8-week, pan-genotypic treatment for patients without cirrhosis who are new to treatment. The drug can be used to treat most the 71 million people globally who live with HCV, according to an AbbVie statement.

“MAVIRET represents an innovation in HCV care as an 8-week, pan-genotypic option that combines two distinct antiviral agents and has high efficacy even against most genotypes commonly associated with resistance to treatment,” said Michael Severino, MD, AbbVie’s executive vice president of research and development, and chief scientific officer. “This new treatment advancement has the potential to meet the diverse needs of patients in as short as 8 weeks across Europe.”

The approval of MAVIRET is supported by data from 8 clinical studies, which included more than 2,300 patients in 27 countries across all major HCV genotypes (GT1-6) and special populations. The drug is also indicated for patients with specific treatment challenges, including compensated cirrhosis across all major genotypes, and those who previously had limited treatment options, like patients with severe chronic kidney disease or those with genotype 3 chronic HCV infection.

The drug met all primary efficacy endpoints across its extensive clinical trial program and achieved high cure rates, according to Stefan Zeuzem, MD, chief of the department of medicine at the JW Goethe University Hospital in Frankfurt, Germany.

“MAVIRET offers a new therapy for the majority of HCV patients and removes many complexities of pre-treatment patient evaluation,” he said.

The new European Commission market authorization Is supported by a 97.5% cure rate with just 8 weeks of treatment in GT1-6 patients without cirrhosis and who were new to treatment, and a cure rate of 98% in compensated cirrhotic patients at 12 weeks of treatment.

Less than 0.1% of patients discontinued treatment due to adverse reactions, the most common of which were headache and fatigue.

The drug’s approval follows an accelerated assessment by the European Medicines Agency (EMA) which is granted to new medicines of major public interest. MAVIRET is licensed for use in all 28 member states of the European Union, as well as Iceland, Liechtenstein and Norway.

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