EPCLUSA (sofosbuvir/ velpatasvir)

Key points

Favourable opinion for reimbursement in the treatment of chronic hepatitis C virus (HCV) infection in patients aged 6 years and older and weighing at least 17 kg.

Favourable opinion for reimbursement in the new form, EPCLUSA (sofosbuvir/velpastasvir) 200 mg/50 mg film-coated tablets.

What therapeutic improvement?

Therapeutic improvement in the management of the disease.

Role in the care pathway?

The reference treatment for chronic hepatitis C in adults and adolescents (from 12 years of age) is now based on direct-acting antiviral combinations. These combinations usually enable a sustained virological response (> 90%) to be obtained, including in cirrhosis patients. The majority of patients can now benefit for 8 to 12 weeks of treatment with ribavirin-free pangenotypic direct-acting antiviral combinations. These pangenotypic regimens are recommended preferentially since they reduce the needs for genotyping or resistance tests to guide treatment decisions.

In children aged under 12 years, due to the slow-progressing nature of the infection in paediatric patients, the guidelines recommend delaying the initiation of treatment pending the availability of pangenotypic combinations: EPCLUSA (sofosbuvir/velpatasvir) and MAVIRET (pibrentasvir/glecaprevir), which are reference options.

Role of the medicinal product in the care pathway

In children who meet the treatment criteria, EPCLUSA (sofosbuvir/velpatasvir) is a reference treatment option, in the same way as MAVIRET (pibrentasvir/glecaprevir), due to its pangenotypic efficacy, shortening the treatment duration (12 weeks) and simplifying treatment (reduced need for genotyping or resistance tests).