Patient-Reported Outcomes in ATLAS and FLAIR Participants on Long-Acting Regimens of Cabotegravir and Rilpivirine Over 48 Weeks

AIDS Behav. 2020 Dec;24(12):3533-3544. doi: 10.1007/s10461-020-02929-8.


The phase 3 ATLAS and FLAIR studies demonstrated that maintenance with Long-Acting (LA) intramuscular cabotegravir and rilpivirine is non-inferior in efficacy to current antiretroviral (CAR) oral therapy. Both studies utilized Patient-Reported Outcome instruments to measure treatment satisfaction (HIVTSQ) and acceptance (ACCEPT general domain), health status (SF-12), injection tolerability/acceptance (PIN), and treatment preference. In pooled analyses, LA-treated patients (n = 591) demonstrated greater mean improvements from baseline than the CAR group (n = 591) in treatment satisfaction (Week 44, + 3.9 vs. +0.5 HIVTSQs-points; p < 0.001) and acceptance (Week 48, +8.8 vs. +2.0 ACCEPT-points; p < 0.001). The acceptability of injection site reactions (PIN) significantly improved from week 5 (2.10 points) to week 48 (1.62 points; p < 0.001). In both studies, ≥ 97% of LA group participants with recorded data preferred LA treatment compared with prior oral therapy. These results further support the potential of a monthly injectable option for people living with HIV seeking an alternative to daily oral treatment.

Keywords: Antiretroviral therapy; Cabotegravir; Long-acting treatment; Patient-reported outcomes; Rilpivirine.

MeSH terms

  • Anti-HIV Agents / therapeutic use*
  • HIV Infections* / drug therapy
  • HIV-1*
  • Humans
  • Injections, Intramuscular
  • Patient Reported Outcome Measures
  • Pyridones / therapeutic use*
  • Rilpivirine / therapeutic use*


  • Anti-HIV Agents
  • Pyridones
  • Rilpivirine
  • cabotegravir