Mavyret (G/P), a fixed-dose combination therapy of glecaprevir/pibrentasvir has been approved by the US Food and Drug Administration (FDA
) for the treatment of chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis, including patients with moderate to severe kidney disease and those who are on dialysis. The therapy is also approved for adult patients with HCV genotype 1 infection who have been previously treated with a regimen either containing an NS5A inhibitor or an NS3/4A protease inhibitor but not both. Approximately 2.7 to 3.9 million people in the United States have chronic HCV, according to the Centers for Disease Control and Prevention.
The treatment is the first to be approved as an 8-week regimen for these patient types. Standard treatment length was originally 12 weeks or more.
Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research stated in the FDA’s press release that, “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.”
According to the FDA, “the safety and efficacy of Mavyret were evaluated during clinical trials enrolling approximately 2,300 adults with genotype 1, 2, 3, 4, 5 or 6 HCV infection without cirrhosis or with mild cirrhosis. Results of the trials demonstrated that 92% to 100% of patients who received Mavyret for 8, 12, or 16 weeks duration, had no virus detected in the blood 12 weeks after finishing treatment, suggesting that patients’ infection had been cured.”
Headache, fatigue and nausea were the most common reported adverse reactions.
“Treatment duration with Mavyret differs depending on treatment history, viral genotype, and cirrhosis status. Mavyret is not recommended in patients with moderate cirrhosis and contraindicated in patients with severe cirrhosis. It is also contraindicated in patients taking the drugs atazanavir and rifampin,” according to the FDA.
In addition, “Hepatitis B virus (HBV) reactivation has been reported in HCV/HBV coinfected adult patients who were undergoing or had completed treatment with HCV direct-acting antivirals, and who were not receiving HBV antiviral therapy. HBV reactivation in patients treated with direct-acting antiviral medicines can result in serious liver problems or death in some patients. Health care professionals should screen all patients for evidence of current or prior HBV infection before starting treatment with Mavyret.”
The FDA granted this application Priority Review
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