IQWiG finds hint of added benefit for Harvoni in further patient group
The German Institute for Quality and Efficiency in Health Care (IQWiG) has assessed documents subsequently submitted by US biotech giant Gilead Sciences (Nasdaq: GILD) in the commenting procedure on the dossier assessment of the firm’s new blockbuster hepatitis C drug Harvoni (ledipasvir and sofosbuvir).
According to the findings, a hint of a non-quantifiable added benefit for a further patient group can be derived from this additional information.
This patient group consists of treatment-naive or pre-treated patients with hepatitis C virus (HCV) infection of genotype 1 who are also infected with HIV, but have not yet developed cirrhosis of the liver. For genotype 1 patients (without cirrhosis) who have no HIV co-infection, the IQWiG had already determined an added benefit in the dossier assessment.
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