FDA Expands Approval for Glecaprevir and Pibrentasvir


The FDA has approved treatment for adults and children with all genotypes of hepatitis C and compensated cirrhosis that shortens duration of treatment to 8 weeks.

The US Food and Drug Administration (FDA) has expanded the approval of glecaprevir and pibrentasvir (Mavyret). Under the expansion, the tablets are now approved for an 8-week duration for treatment-naïve children ages 12 years and older and adults who have chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection and compensated cirrhosis. The approval was granted to AbbVie Inc.

According to the US Centers for Disease Control and Prevention, between 2.7 and 3.9 million people in the United States have chronic HCV, and children born to HCV-positive mothers are at risk for HCV infection. It is estimated that there are 23,000 to 46,000 children in the United States with HCV infection.

The FDA's statement indicates that glecaprevir and pibrentasvir is now the first 8-week treatment approved for adults and certain pediatric patients with HCV genotypes 1-6 without cirrhosis and with compensated cirrhosis. Previously, standard treatment for patients with compensated cirrhosis was at least 12 weeks.

“This approval provides a treatment duration of 8 weeks for both pediatric and adult patients with compensated cirrhosis regardless of HCV genotype; meaning that an 8-week treatment regimen is available for any treatment-naïve HCV patient, regardless of cirrhosis status or genotype,” said Jeffrey Murray, MD, deputy director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research, in the announcement. “Mavyret is a combination of direct-acting antiviral drugs that reduce the amount of HCV in the body to undetectable levels by preventing the virus from multiplying, and in most cases, curing HCV infection.”

Glecaprevir and pibrentasvir was evaluated in clinical trials which cumulatively enrolled more than 2500 people with HCV genotype 1, 2, 3, 4, 5 or 6 infections who received glecaprevir and pibrentasvir for 8 12 or 16 weeks duration. The trials enrolled patients with HIV-co-infection, kidney or liver transplant recipients and patients with advanced kidney disease, including those requiring hemodialysis.

In these trials, the efficacy of the regimen was measured by the proportion of participants that achieved virologic cure. Virologic cure is the lack of detectable HCV in the blood after completion of HCV therapy, known as sustained virologic response (SVR). Standard measure of virologic cure is SVR at 12 weeks post-treatment. Across clinical trials, SVR12 rates have ranged from 91-100 for glecaprevir and pibrentasvir.

Among patients taking glecaprevir and pibrentasvir, the most common adverse reactions are headache and fatigue.

The FDA notes that glecaprevir and pibrentasvir is contraindicated in patients with moderate or severe liver impairment or in those with any history of liver decompensation. It is also contraindicated in patients taking the drugs atazanavir and rifampin.

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