On 11 June, AbbVie's pan-genotypic direct-acting antiviral (DAA) therapy Mavyret (glecaprevir + pibrentasvir) received US market approval for treating acute or chronic hepatitis C virus (HCV) infections in patients aged 3+ without cirrhosis, marking the first 8-week acute HCV regimen with 96% rate of sustained virological response at week 12 (SVR12).

The approval was based on Phase III M20-350 trial results (n=286), showing 96.1% efficacy in intention-to-treat (ITT) and 99.6% in modified ITT-virological failure (mITT-VF) groups. No treatment discontinuations or drug-related serious adverse events occurred.

Originally approved in 2017 for chronic HCV, Mavyret's expanded indication addresses unmet needs in acute HCV management. Untreated HCV costs the US an estimated USD 120 billion in liver disease expenses over the next decade.