FDA Approves Mavyret for Chronic HCV

Fixed-dose combination therapy glecaprevir/pibrentasvir (Mavyret, G/P) has been approved by the US Food and Drug Administration (FDA) for the treatment of chronic hepatitis C virus (HCV).

The treatment — with NS3/4A protease inhibitor glecaprevir and NS5A inhibitor pibrentasvir — is a therapy designed for all major genotypes of chronic HCV by biopharmaceutical company AbbVie. It provides HCV patients with a shorter, 8-week treatment option, taken once daily.

As an investigational drug, G/P reported almost perfect sustained virology response (SVR) in a Phase III trial involving 146 chronic HCV patients with genotype 1, 2, 4, 5 or 6 and compensated cirrhosis.

Of the 146 tested patients, 145 (99%) had achieved SVR at the 12 weeks post-treatment mark, according to researchers from the EXPEDITION-1 study.

At the time of the trial’s report earlier this year, Xavier Forns, MD, head of the hepatitis unity at Hospital Clinic de Barcelona in Spain, said great progress in treating HCV patients with compensated cirrhosis has lacked similar success with the use of oral interferon ribavirin.

“The positive findings from the EXPEDITION-1 study, along with previously reported data, show that G/P has the potential to become a ribavirin-free treatment for patients with compensated cirrhosis across these genotypes,” Forns said.

The most commonly reported adverse events in the trial study were fatigue and headaches, though all reported were mild and did not cause discontinuation of treatment.

More recently, G/P had received approval from the European Medicine Agency (EMA) for marketing authorization, allowing it to be marketed in Europe.

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