Results from a total of 3 studies were available. Since, at the time of the assessment, only analyses after 48 weeks were fully available for the two largest studies, IQWiG's assessment is based on these analyses.
In all 3 studies, rilpivirine was tested as a single agent. Nevertheless, the results are also relevant for the assessment of the combination product, because the dosage of rilpivirine, emtricitabine and tenofovir administered in these studies corresponds exactly to the dosage in the fixed combination.
Viral load is a sufficiently valid surrogate parameter
In its dossier, the manufacturer of the single agent did not submit any data on the patient-relevant outcome "AIDS-defining diseases/death", i.e. on the outbreak of AIDS and on survival. Instead, the manufacturer used results of "viral load" in order to prove the added benefit. The viral load denotes the number of components of a virus present in the blood and it shows how active HIV is.
In principle, IQWiG considers this "surrogate parameter" as valid, i.e. meaningful, because patients in whom the number of viruses can be persistently suppressed below the limit of detection have, according to the current state of knowledge, a lower risk of developing AIDS or of dying. However, it is unclear whether a treatment has just as great an effect on the patient-relevant outcome as on the surrogate parameter.
Effect depends on gender
As regards the reduction in viral load, the 3 studies showed a statistically significant difference in favour of rilpivirine. However, as shown by the data on subgroups presented in this dossier [on the single agent], this only applies to male patients. This means that gender is here an "effect modifier". IQWiG therefore determines that there is proof of an added benefit in HIV-1-infected men, but not in women. Because of the described uncertainty concerning the siz
|Contact: Dr. Anna-Sabine Ernst|
Institute for Quality and Efficiency in Health Care