No added benefit for tenofovir alafenamide in chronic hepatitis B, says IQWiG

The antiviral drug tenofovir alafenamide (TAF) has been used since 2015 in different combinations for the treatment of HIV and has already been subject to three early benefit assessments for this therapeutic indication by the German Institute for Quality and Efficiency in Health Care (IQWiG).

In January this year, the European Commission granted marketing authorization for US biotech major Gilead Sciences’ (Nasdaq: GILD) Vemlidy (tenofovir alafenamide, TAF) for the treatment of chronic hepatitis B virus (HBV) infection in adults and adolescents. The IQWiG has now examined in a further early benefit assessment whether the drug offers an added benefit for these patients.

In its dossier, the drug manufacturer presented no data for treatment-naive or pretreated adolescents aged12 and older. The data from two studies presented by the manufacturer for treatment-naive or pretreated adults were incomplete to a major extent and for this reason alone were unsuitable for a benefit assessment. In addition, the delineation between treatment-naive and treatment-experienced patients was contradictory, and the appropriate comparator therapy was partly not implemented. Hence an added benefit in comparison with the respective appropriate comparator therapy is not proven for any of the four patient groups mentioned.