The drug, Mavyret, is manufactured by AbbVie Inc. and is intended for people without cirrhosis or mild cirrhosis.
The U.S. Food and Drug Administration (FDA) announced today its approval for a new drug to treat chronic hepatitis C, including patients with moderate or severe kidney disease and those who are on dialysis.
Approximately 3.4 million Americans are chronically infected with HCV.
"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. Mavyret is the first 8-week treatment regimen approved for all HCV genotypes 1-6 in treatment-naïve adults without cirrhosis, according to the release.
The list price without insurance will range from $26,400 for eight weeks' treatment to $52,800 for 16 weeks' treatment.
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Some patients who have chronic HCV infection over several years can get jaundice (yellowish skin or eyes) and complications such as infections, bleeding, fluid accumulation in the abdomen, liver cancer, and death.
The approval of MAVYRET is supported by data from nine registrational studies in AbbVie's clinical development program, which evaluated more than 2,300 patients in 27 countries across all major HCV genotypes (GT1-6) and special populations.
The most common adverse reactions in patients taking Mavyret were headache, fatigue and nausea.
"The clinical trial programme for Mavyret resulted in high cure rates across a range of patient populations, from those who have never been treated and who do not have cirrhosis, all the way to patients with compensated cirrhosis", said Fred Poordad, vice president, academic and clinical affairs, Texas Liver Institute and professor of medicine, University of Texas Health, San Antonio. It also should not be taken with atazanavir or rifampin.
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.
The FDA previously granted Mavyret Breakthrough Therapy designation as well as Priority Review.