WASHINGTON -- A novel two-drug combination pill for hepatitis C virus (HCV) infection that can be taken in an 8-week course and is effective against all major viral genotypes is now approved, the .
The product, called Mavyret, includes the direct antiviral agents glecaprevir and pibresentasvir. It is manufactured by AbbVie.
"Mavyret is the first treatment of 8 weeks duration approved for all HCV genotypes 1-6 in adult patients without cirrhosis who have not been previously treated," the agency said. The product is also approved as second-line treatment for HCV genotype 1 in patients previously receiving either an NS5A inhibitor or NS3/4A inhibitor but not both.
Approval was based on a series of trials involving some 2,300 HCV-infected patients with no or mild cirrhosis. Viral cure -- undetectable virus 12 weeks after starting treatment -- was achieved in 92%-100% of patients in the trials, in which treatment lasted 8-16 weeks.
The FDA noted that the recommended treatment duration for Mavyret will differ according to patients' treatment history, viral genotype, and cirrhosis status. The drug is absolutely contraindicated in patients with severe cirrhosis and not recommended for those with moderate cirrhosis. It also should not be taken with atazanavir or rifampin.
As with other direct-acting antivirals for HCV, Mavyret may cause reactivation of hepatitis B in co-infected patients. Screening for current or previous HBV infection is recommended for all patients considered for Mavyret therapy.