Fewer neurological side effects
Rilpivirine as a single agent also has advantages in terms of side effects: "neurological events" such as headaches or insomnia occurred less frequently. However, the analysis presented by the manufacturer contains a few uncertainties, which is why IQWiG considers there is no proof here, but only an "indication" of a lesser harm with rilpivirine compared to efavirenz.
Based on the overall results on side effects and viral load, the Institute considers that for male patients, there is proof of a considerable added benefit and for female patients a corresponding "indication".
No proof of added benefit of the fixed combination
In contrast to the single agent, there is no proof of an added benefit for the fixed combination of rilpivirine, emtricitabine and tenofovir. In its dossier the manufacturer did not analyse the available data in a suitable way.
Subgroup analyses (age, gender, severity of disease etc.) are routinely required in every dossier. However in this case the manufacturer did not carry these out, despite the fact that its dossier refers to the same studies reported in the dossier submitted by the manufacturer of the rilpivirine single agent, in which gender had been identified as an effect modifier. It is, however, precisely under these circumstances that such subgroup analyses are essential. The necessary data that the manufacturer should have analysed in an appropriate manner were indeed available. The pharmaceutical company also gives no reasons why the subgroup analyses were not provided.
In addition, the company excluded one study although it contained relevant information. The manufacturer of the single agent product accordingly included this study in its dossier.
In view of these deficiencies, IQWiG consi
|Contact: Dr. Anna-Sabine Ernst|
Institute for Quality and Efficiency in Health Care