FDA Further Expands Approval of HCV Combo Drug Mavyret

Megan Brooks

September 26, 2019

The US Food and Drug Administration (FDA) has approved an 8-week course of glecaprevir/pibrentasvir tablets (Mavyret, AbbVie Inc) for treatment-naive adults and children at least 12 years old or weighing at least 99 pounds who have chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection and compensated cirrhosis

Glecaprevir/pibrentasvir becomes the first 8-week treatment approved for all treatment-naive adult and certain pediatric patients with HCV genotypes 1-6 without cirrhosis and with compensated cirrhosis, the FDA said in a news release.  Previously, 12 weeks was the standard duration of glecaprevir/pibrentasvir treatment for these patients.

The FDA approved the 8-week glecaprevir/pibrentasvir regimen for adults with chronic HCV genotypes 1 through 6 without cirrhosis or with mild cirrhosis in August 2017, as reported by Medscape Medical News.

"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," Jeffrey Murray, MD, deputy director, Division of Antiviral Products in the FDA's Center for Drug Evaluation and Research, said in the release.

The US Centers for Disease Control and Prevention (CDC) estimates that 2.7 million to 3.9 million people in the United States have chronic HCV infection, and children born to HCV-infected mothers are at risk for HCV infection. Researchers estimate there are 23,000 to 46,000 US children with HCV infection.

The efficacy and safety of glecaprevir/pibrentasvir was demonstrated in clinical trials, which cumulatively evaluated more than 2500 people with HCV genotype 1 to 6 who received treatment for 8, 12, or 16 weeks. The trials included patients coinfected with HIV, as well as kidney or liver transplant recipients and patients with advanced kidney disease, including those requiring hemodialysis.

With glecaprevir/pibrentasvir, sustained virologic response at 12 weeks posttreatment (SVR12), the standard measure of virologic cure, have ranged from 91% to 100% across clinical trials.

The most common adverse reactions in patients taking the drug combination are headache and fatigue. Glecaprevir/pibrentasvir should not be used in patients with moderate or severe liver impairment (Child-Pugh B or C) or in those with any history of liver decompensation. It is also contraindicated in patients taking atazanavir and rifampin.

More information about today's approval is available on the FDA website.

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