Rilpivirin (Rekambys, 1) – Rekambys®

• Clinical trials
  • The ATLAS-2M trial is an open-label, randomised, parallel-group study investigating the treatment regimen of rilpivirine and cabotegravir Q2M compared with Q1M.
  • The FLAIR trial is an open-label, randomised, parallel-group trial investigating rilpivirine + cabotegravir Q1M compared with abacavir/dolutegravir/lamivudine (ABC/DTG/3TC).

Adults with HIV-1 infection who are virologically suppressed on a stable antiretroviral regimen (HIV-1 RNA < 50 copies/ml) with no current or historically documented resistance to the NNRTI or INI classes and no history of virological failure with active ingredients from the NNRTI and INI classes.

• The additional benefit is not proven.
• Overall, the pharmaceutical manufacturer did not submit any data for the present therapeutic indication that would have been suitable for assessing the additional benefit of rilpivirine in combination with cabotegravir compared with the appropriate comparator therapy.
• mortality
  • Other patient-relevant endpoints include mortality, morbidity, health-related quality of life and adverse events (AEs).
• morbidity
  • Other patient-relevant endpoints include mortality, morbidity, health-related quality of life and adverse events (AEs).
• Health-related quality of life
  • Other patient-relevant endpoints include mortality, morbidity, health-related quality of life and adverse events (AEs).
• Side effects
  • Other patient-relevant endpoints include mortality, morbidity, health-related quality of life and adverse events (AEs).

Courtesy translation only, please refer to the German original.