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

• 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.