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SOVALDI

-
Opinions on drugs - Posted on Sep 11 2014

Reason for request

Inclusion

-


Clinical Benefit

Substantial

Substancial


Clinical Added Value

important

Given :

- 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.

moderate

- a moderate improvement in actual benefit (IAB III) in the treatment of antiviral treatment-naïve adult patients infected with genotype 3 HCV.


Ce produit a fait l'objet d'un avis d'efficience rendu par la Commission évaluation économique et santé publique

le 15 avril 2014.