VIREAD (ténofovir disoproxil (fumarate de))

Chronic hepatitis B - Sectors: Retail and hospital

Opinions on drugs - Posted on Apr 03 2020

Reason for request

New indication

Key points

Favourable opinion for reimbursement in the indication extension for the treatment of chronic hepatitis B in paediatric patients aged 2 to <12 years, with compensated liver disease.

What therapeutic improvement?

Therapeutic improvement, in the same way as entecavir (BARACLUDE) and peginterferon alfa-2a (PEGASYS).

Role in the care pathway?

In children and adolescents, treatments for chronic hepatitis B must be prescribed as part of specific protocols and include specialised monitoring.

Where antiviral treatment is indicated, two first-line strategies can be discussed:

peginterferon alfa-2a (PEGASYS) for a limited 48-week period,
a nucleoside or nucleotide analogue for an extended period, i.e., tenofovir disoproxil fumarate (VIREAD) or entecavir (BARACLUDE), the only products to have a marketing authorisation in this indication.

Role of the medicinal product in the care pathway

VIREAD is a first-line treatment option, in the same way as entecavir (BARACLUDE) or peginterferon alfa-2a (PEGASYS) when antiviral treatment is indicated. However, despite an efficacy and safety profile in paediatric populations that appears to be similar to that in adults, its use in this growing population should take into account the risk of renal and bone toxicity. The SPC indicates that there are “uncertainties associated with the long term effects of bone and renal toxicity. Moreover, the reversibility of renal toxicity cannot be fully ascertained. Therefore, a multidisciplinary approach is recommended to adequately weigh on a case by case basis the benefit/risk balance of treatment, decide the appropriate monitoring during treatment (including decision for treatment withdrawal) and consider the need for supplementation”.

Special recommendations

The Committee reiterates that the expected benefit of treatment should be carefully evaluated in view of the safety data from clinical studies conducted in children and adolescents and that the decision to treat should be made on a case by case basis.

Clinical Benefit

Substantial

Consequently, the Committee considers that the clinical benefit of VIREAD is substantial in the indication extension for the treatment of chronic hepatitis B in paediatric patients aged 2 to <12 years, with compensated liver disease.

Clinical Added Value

minor

Considering:

demonstration of the efficacy versus placebo in terms of virological response, of the same magnitude as that observed in previous studies in adults and adolescents, with a good resistance profile,
an effect size that appears to be similar to that described with the available alternatives but,
uncertainties associated with the long term effects of bone and renal toxicity and,
the limited number of therapeutic alternatives with an MA in children, i.e., entecavir (BARACLUDE) and peginterferon alfa-2a (PEGASYS),

the Committee considers that VIREAD (tenofovir), in the same was as BARACLUDE and PEGASYS, provides a minor clinical added value (CAV IV) in the treatment of chronic hepatitis B in paediatric patients aged 2 to <12 years, with compensated liver disease.