VOSEVI (sofosbuvir / velpatasvir / voxilaprevir), fixed direct-acting antiviral combination
Reason for request
High clinical benefit for the treatment of chronic Hepatitis C genotypes 1 to 6 and minor clinical added value compared to the current therapeutic strategy for adults patients infected with HCV genotypes 1 to 6
VOSEVI has been granted a marketing authorisation for the treatment of chronic hepatitis C in adults infected with hepatitis C virus (HCV) genotypes 1 to 6.
Its pan-genotypic virological efficacy is high (>90%), with a treatment duration between 8 and 12 weeks based on the patients' liver disease with or without compensated cirrhosis (Child-Pugh A only).
Its efficacy has been demonstrated in patients for whom treatment with previously available direct-acting antivirals has failed, in particular for whom NS5A inhibitor therapy has failed, for whom the therapeutic options available are very limited and insufficiently validated.
Its safety and resistance profile is satisfactory but it has a high medicinal interaction potential.
Clinical Added Value