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EPCLUSA (sofosbuvir/velpatasvir), fixed combination of direct-acting antivirals

Opinions on drugs - Posted on Mar 03 2017

Reason for request

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

Like other direct-acting antivirals (HARVONI, DAKLINZA, OLYSIO, VIEKIRAX, EXVIERA), minor clinical added value in the treatment of genotype 1 to 6 chronic hepatitis C. 


  • EPCLUSA has Marketing Authorisation in the treatment of chronic hepatitis C in adults infected with genotype 1 to 6 hepatitis C virus (HCV).
  • Its pangenotypic virological efficacy is substantial, with a treatment duration of 12 weeks for all patients (with or without cirrhosis), unlike the available alternatives that most often require the addition of ribavirin and/or prolongation of treatment duration up to 24 weeks in case of complicated cirrhosis or treatment history.
  • Its efficacy is superior to the sofosbuvir + ribavirin combination for genotype 2, but is not optimal for genotype 3.
  • Its safety, resistance and drug interaction profile is satisfactory.
  • It has not been compared to the other sofosbuvir + NS5A inhibitor-based combinations available.



Clinical Benefit




Clinical Added Value



Therapeutic use


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