IQWiG backs Harvoni for certain HCV patients, rebuffs Otezla
The German Institute for Quality and Efficiency in Health Care (IQWiG) said in a dossier assessment that Harvoni ledipasvir/ sofosbuvir from Gilead Sciences Inc. (NASDAQ:GILD) had a "hint" of an added benefit in non-cirrhotic patients co-infected with HCV genotype 1 and HIV. The agency said the benefit was non-quantifiable because it was unclear to what extent late complications including liver cancer were preventable in patients in whom the virus was no longer detectable. IQWiG previously said Harvoni had "a hint of a non-quantifiable added benefit" for pre-treated HCV genotype 1 patients and non-cirrhotic treatment-naive HCV genotype 1 patients, and no added benefit in patients with HCV genotype 4 or genotype 3 with decompensated cirrhosis of the liver. ...