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

INFECTIOUS DISEASES - NEW MEDICINAL PRODUCT

Opinions on drugs - Posted on Mar 03 2017

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

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.

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