SOVALDI (sofosbuvir)

Key points

Favourable opinion for reimbursement in the treatment of chronic hepatitis C (CHC) in paediatric patients aged 3 to < 12 years.

Favourable opinion for reimbursement of the new SOVALDI (sofosbuvir) 200 mg film-coated tablets, 200 mg coated granules in sachet and 150 mg coated granules in sachet forms.

What therapeutic improvement?

No clinical added value in the therapeutic strategy in children aged 3 to < 12 years.

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, SOVALDI (sofosbuvir) in combination with ribavirin, is a first-line option for the treatment of chronic hepatitis C related to genotype 2 and 3 HCV. However, its role becomes very limited (or even non-existent) following the availability of ribavirin-free pangenotypic direct-acting antiviral combinations, which simplify treatment and shorten the treatment duration (8 to 12 weeks for the majority of patients).