MAVIRET (glecaprevir /pibrentasvir), fixed direct-acting antiviral combination

INFECTIOUS DISEASE - New medicinal product
Opinions on drugs - Posted on Jul 06 2018

Reason for request

Inclusion

High clinical benefit for the treatment of chronic hepatitis C virus genotypes 1 to 6 and minor clinical added value compared to other previously available direct-acting antiviral combinations

 

 

 

  • MAVIRET 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, with a treatment duration of 8 to 12 weeks for most patients without cirrhosis or with compensated cirrhosis.

  • Its efficacy has been demonstrated in specific populations such as kidney failure or haemodialysis patients for whom the alternatives are limited.

  • Its safety and resistance profiles are satisfactory but it has a high medicinal interaction potential.

 


Clinical Benefit

Substantial

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Clinical Added Value

minor

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