Mavyret marks the first eight-week treatment approved for patients with HCV genotypes 1-6 both without cirrhosis and with compensated cirrhosis
Image: FDA lab at Building 64 in Silver Spring, Maryland. Photo: Courtesy of The U.S. Food and Drug Administration/Wikipedia.
The US Food and Drug Administration (FDA) has expanded the approval for Mavyret (glecaprevir and pibrentasvir) tablets for an eight-week duration for the treatment of infection caused by all genotypes of chronic hepatitis C virus (HCV) and compensated cirrhosis.
The medication is indicated for adults and children, age 12 years and above, weighing at least 99 pounds, and have not been previously treated for HCV.
FDA Centre for Drug Evaluation and Research antiviral products division deputy director Jeffrey Murray said: “This approval provides a treatment duration of eight weeks for both pediatric and adult patients with compensated cirrhois regardless of HCV genotype; meaning that an eight-week treatment regimen is available for any treatment-naïve HCV patient, regardless of cirrhosis status or genotype.
“Mavyret is a combination of direct-acting antiviral drugs that reduce the amount of HCV in the body to undetectable levels by preventing the virus from multiplying, and in most cases, curing HCV infection.”
Mavyret showed 91 to 100% SVR 12 rates in clinical trials
The US Centres for Disease Control and Prevention estimates 2.7 to 3.9 million people have chronic HCV, and children born to HCV-positive mothers are at risk for HCV infection in the US.
HCV is a viral disease characterised by causing inflammation of the liver, which could lead to weakened liver function or even liver failure. The standard treatment for patients with compensated cirrhosis would take 12 weeks or more.
FDA said that the Mavyret marks the first eight-week treatment to be approved for patients with HCV genotypes 1-6 both without cirrhosis and with compensated cirrhosis.
The clinical trials that cumulatively enrolled more than 2,500 people with HCV infection have evaluated the safety and efficacy of Mavyret for eight, 12 or 16 weeks duration.
In addition, the trials also included patients with HIV-co-infection, kidney or liver transplant recipients and patients with advanced kidney disease, and with requiring haemodialysis.
The efficacy of HCV treatment is measured based on the virologic cure. The lack of detectable HCV in the blood at certain time points after completion of HCV therapy is known as sustained virologic response (SVR), and SVR at 12 weeks post-treatment (SVR 12) is the standard measure of virologic cure.
Headache and fatigue are the most common adverse reactions in patients subjected to Mavyret, and the regimen is not advised for patients with moderate or severe liver impairment, those with any history of liver decompensation, and patients on atazanavir and rifampin drugs.