EU Approves Pan-Genotypic Drug for Chronic Hepatitis C Virus


Maviret is an 8-week treatment that combines 2 distinct antiviral agents.

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.

Related Videos
Pharmacist holding medicine box in pharmacy drugstore. | Image Credit: I Viewfinder -
Pharmacy Drugstore Checkout Cashier Counter | Image Credit: Gorodenkoff -
Medicine tablets on counting tray with counting spatula at pharmacy | Image Credit: sutlafk -
Capsules medicine and white medicine bottles on table | Image Credit: Satawat -
Human cell or Embryonic stem cell microscope background | Image Credit: Anusorn -
Concept of health care, pharmaceutical business, drug prices, pharmacy, medicine and economics | Image Credit: Oleg -
Biosimilar pharmaceutical drug bottle on blue background. | Image Credit: Carl -
Pharmaceutical manufacture background with glass bottles with clear liquid on automatic conveyor line. | Image Credit: wacomka -
Bottle and scattered pills on color background, top view | Image Credit: New Africa -
pharmacy | Image Credit: Diego Cervo -
© 2024 MJH Life Sciences

All rights reserved.