Reason for request
Clinical Added Value
- its higher efficacy for the most difficult to treat patients, in particular genotype 1, 4, 5 and 6 patients, cirrhotic patients, pre-transplantation patients and patients co-infected with HIV and HCV,
- its efficacy for genotype 2 and 3 patients, including those with a failed previous treatment, but with a higher response for genotype 2 patients (a short-term 12 week treatment of dual therapy with ribavirin, without interferon) than for genotype 3 patients (requiring extension of treatment to 24 weeks with dual therapy with ribavirin, or even short-term 12 week treatment as triple therapy with interferon),
- its satisfactory safety, resistance and interaction with other medicines profiles observed during clinical studies,
the Committee considers that SOVALDI, in combination with pegylated interferon alpha and/or ribavirin, provides :
- a substantial improvement in actual benefit (IAB II) in the treatment of all adult patients infected with HCV, except for antiviral treatment-naïve genotype 3 patients.
- a moderate improvement in actual benefit (IAB III) in the treatment of antiviral treatment-naïve adult patients infected with genotype 3 HCV.