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ZEPATIER (elbasvir grazoprevir), fixed combination of direct-acting antivirals

INFECTIOUS DISEASES - NEW MEDICINAL PRODUCT
Opinions on drugs - Posted on Mar 13 2017

Reason for request

Re-assessment of the actual benefit and of the improvement in actual benefit and of Inclusion

Minor clinical added value, like other direct-acting antivirals (HARVONI, DAKLINZA, OLYSIO, VIEKIRAX, EXVIERA),  in the treatment of genotype 1 and 4 chronic hepatitis C. 

 

 

  • ZEPATIER has Marketing Authorisation in the treatment of chronic hepatitis C in adults infected with genotype 1 and 4 hepatitis C virus (HCV).
  • It represents minor clinical added value in treatment, given:

 -       its substantial virological efficacy in patients infected with genotype 1 and 4 HCV with a treatment duration of 12 to 16 weeks (± ribavirin) for patients with or without compensated cirrhosis (Child-Pugh A only),

 -       the demonstration of efficacy superior to sofosbuvir + peg-interferon/ribavirin triple therapy (comparator that is no longer optimal), with an extent of effect comparable to the alternatives currently recommended,

 -       the demonstration of significant efficacy in specific populations, such as renal failure or dialysis patients, for whom the alternatives are limited and insufficiently evaluated,

 -       its satisfactory safety profile,

 -       its significant risk of developing resistance in the case of treatment failure,

 -       the absence of comparison with the other direct-acting antiviral combinations available, such as sofosbuvir + NS5A inhibitor combinations which most often allow a shorter treatment duration (8-12 weeks) without addition of ribavirin.

 

 


Clinical Benefit

Substantial

-

Unspecified

Clinical Added Value

minor

-


Therapeutic use

-

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