The first pangenotypic treatment for the hepatitis C virus, which also shaves 4 weeks off current regimens, has just been approved by the Food and Drug Administration.
Manufactured by AbbVie, glecaprevir/pibrentasvir (Mavyret) combines a nonstructural protein 3/4A protease inhibitor with a next-generation NS5A protein inhibitor for a once-daily, ribavirin-free treatment for adults with any of the major genotypes of chronic hepatitis C virus (HCV) infection.
“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,” Edward Cox, MD, director of the office of antimicrobial products in the FDA’s Center for Drug Evaluation and Research, Silver Spring, Md., said in a statement.
The 8-week regimen is indicated in patients without cirrhosis or with compensated cirrhosis, who are new to treatment, and those with limited treatment options, such as patients with chronic kidney disease, including those on dialysis. The intervention also is indicated in adults with HCV genotype 1 who have been treated with either of the drugs in the combination, but not both. Glecaprevir/pibrentasvir is not recommended in patients with moderate cirrhosis and is contraindicated in patients with severe cirrhosis and in those taking the drugs atazanavir and rifampin.
The safety and efficacy of the treatment were evaluated in approximately 2,300 adults with genotype 1, 2, 3, 4, 5 or 6 HCV infection without cirrhosis or with mild cirrhosis. In the clinical trials, between 92% and 100% of patients treated with glecaprevir/pibrentasvir for 8, 12, or 16 weeks had no detectable serum levels of the virus 12 weeks after finishing treatment. The most commonly reported adverse reactions were headache, fatigue, and nausea.
The FDA directs health care professionals to test all patients for current or prior hepatitis B virus (HBV) infection prior to starting this direct-acting antiviral drug combination since HBV reactivation has been reported in adult patients coinfected with both viruses who were undergoing or had completed treatment with HCV direct-acting antivirals and who were not receiving HBV antiviral therapy.
On Twitter @whitneymcknight