EU Approves Pan-Genotypic Drug for Chronic Hepatitis C Virus

The European Commission granted approval this week for glecaprevir/pibrentasvir (Maviret) to treat chronic hepatitis C virus (HCV) in genotypes 1 through 6.

The approval was based on positive data from 8 studies, which included more than 2300 patients across 27 countries. After an 8-week period, Maviret demonstrated a 97.5% cure rate in treatment-naïve patients without cirrhosis, according to PBR Regulatory Affairs.

Maviret is a combination of 100 mg of glecaprevir and 40 mg of pibrentasvir, and is indicated to be taken once-daily for 8 weeks.

“Maviret represents an innovation in HCV care as an 8-week, pan-genotypic option that combines 2 distinct antiviral agents and has high efficacy event against most genotypes commonly associated with resistance to treatment,” Michael Severino, executive vice president of research and development, chief scientific officer at AbbVie, told PBR Regulatory Affairs. “This new treatment advancement has the potential to meet the diverse needs of patients in as short as 8 weeks across Europe.”

The approval is also indicated for patients with treatment challenges, such as compensated cirrhosis, for all major genotypes. It is also covered to treat patients with severe chronic kidney disease or with chronic HCV genotype 2—–who have had limited treatment options in the past.

The drug is licensed to be used in all the European Union member states and in Norway, Iceland, and Liechtenstein.

In the United States, the drug was approved on Thursday under the brand name Mavyret.