Tenofovir alafenamide in chronic hepatitis B: Added benefit not proven, data incomplete
In its dossier, the drug manufacturer presented no data for treatment-naive or pretreated adolescents aged 12 and older. The data from 2 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 4 patient groups mentioned. What does "pretreated" mean? The Federal Joint Committee (G-BA) differentiated between 4 groups of patients by age (adults or adolescents) and by antiviral pretreatment (treatment-naive or treatment-experienced) and specified corresponding appropriate comparator therapies. For adults, the TAF manufacturer presented data from 2 studies. Both st...