EPCLUSA (sofosbuvir/velpatasvir), fixed combination of direct-acting antivirals
INFECTIOUS DISEASES - NEW MEDICINAL PRODUCT
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 Added Value
Évaluation des médicaments