The US Food and Drug Administration has expanded the scope of Harvoni allowing its use in patients with genotype 4, 5 and 6 chronic hepatitis C virus infection and in those co-infected with HIV.
In addition, a 12-week combination of Harvoni (ledipasvir/sofosbuvir) plus ribavirin (RBV) was cleared as an alternate to 24 weeks of Harvoni for treatment-experienced, genotype 1 patients with cirrhosis.
The move significantly widens Harvoni’s reach, given that its original approval – in October 2014 – only allowed treatment chronic HCV genotype 1 infection.
“Harvoni – the first and only single-tablet regimen for the treatment of HCV – continues to demonstrate high cure rates and a tolerable side effect profile across a range of patient populations, including those who have historically been considered among the most difficult to cure,” said Norbert Bischofberger, Gilead’s chief scientific officer.
