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VOSEVI (sofosbuvir / velpatasvir / voxilaprevir), fixed direct-acting antiviral combination

INFECTIOUS DISEASE - New medicinal product
Opinions on drugs - Posted on Jan 04 2018

Reason for request

Inclusion

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 Benefit

Substantial

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Clinical Added Value

minor

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