FDA Approves Mavyret for Treatment of All Hepatitis C Genotypes

On August 3, 2017, the U.S. Food and Drug Administration (FDA) approved Mavyret (glecaprevir and pibrentasvir) for chronic hepatitis C treatment. Mavyret is approved for genotypes 1-6, and can be used to treat adults without cirrhosis or those who have mild compensated cirrhosis, including people with chronic kidney disease and those on dialysis.1

The newly approved Mavyret is the first treatment approved for a duration of eight weeks. Most treatment regimens for hepatitis C are at least 12 weeks in duration.1,2

Researchers have identified at least six genotypes, or strains, of the virus that causes hepatitis C. Most Americans with HCV (approximately 75%) have genotype 1, and another 20-25% have genotype 2 or 3. Genotypes 4, 5, and 6 are more rarely found in people with HCV. Knowing the genotype of HCV can help physicians guide treatment recommendations.

“This approval provides a shorter treatment duration for many patients, and also a treatment option for certain patients with genotype 1 infection, the most common HCV genotype in the United States, who were not successfully treated with other direct-acting antiviral treatments in the past,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.1

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Clinical Trial Evidence

The approval of Mavyret comes after data from clinical trials showed promising results. Over 2,300 patients with all major HCV genotypes in 27 countries participated in clinical trials. The clinical trials demonstrated that 92-100% of patients who received Mavyret for eight, 12 or 16 weeks duration had no virus detected in the blood 12 weeks after finishing treatment, meaning they had been cured of the virus. The most common side effects reported in patients taking Mavyret were headache, fatigue and nausea.1

Treatment Duration and Dosage

Mavyret is an 8-week treatment for adults with all genotypes who have not been previously treated and do not have cirrhosis. For those with compensated cirrhosis who have not previously treated, 12 weeks of treatment is recommended.3

Mavyret is also approved to treated those with genotype 1 who have previously treated with an NS3/4A protease inhibitor, but not an NS5A hibitor for a duration of 12 weeks, as well as those who have previously treated with an NS5A inhibitor, but not an NS3/4A protease inhibitor for a duration of 16 weeks.3

The recommended dosage of Mavyret is three tablets (total daily dose: glecaprevir 300 mg and pibrentasvir 120 mg) taken orally once daily with food.3

Things to Know About Mavyret

In patients who also have hepatitis B virus (HBV), treatment with Mavyret may reactivate their HBV infection, which may result in serious liver problems or death. All patients should be screened for a current or prior HBV infection before starting treatment with Mavyret.

Mavyret is not recommended for patients with moderate cirrhosis and is contraindicated in patients with severe cirrhosis. Patients taking the drugs atazanavir and rifampin should not take Mavyret.1

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