The US Food and Drug Administration (FDA) stated on Thursday that Mavyret is the first eight-week treatment for all treatment-naïve adult and certain paediatric patients with HCV genotypes 1-6 both without cirrhosis and with compensated cirrhosis.

The FDA granted the approval of Mavyret to AbbVie Inc (NYSE:ABBV).

HCV is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure.

The agency has approved Mavyret (glecaprevir and pibrentasvir) tablets for an eight-week duration for the treatment of adults and children ages 12 years and older or weighing at least 99 pounds who have chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection and compensated cirrhosis and have not been previously treated for HCV (treatment-naïve).

Previously, the standard treatment length for patients with compensated cirrhosis was 12 weeks or more, the FDA said.

The efficacy and safety of Mavyret was established in the company's clinical trials, which cumulatively evaluated 2,500 people with HCV genotype 1, 2, 3, 4, 5 or 6 infection for eight, 12 or 16 weeks. The clinical trials achieved virologic cure, which is the lack of detectable HCV in the blood at certain time points after completion of HCV therapy (sustained virologic response, SVR). Rates of SVR at 12 weeks post-treatment have ranged from 91-100% across clinical trials.