Background: New modes of HIV treatment are needed to improve adherence and patient choice. ATLAS a phase 3, open-label study enrolling virally suppressed participants demonstrated switching to monthly long-acting (LA) formulations of Cabotegravir (CAB) + Rilpivirine (RPV) is non-inferior to current ART (CAR) at Week 48. A planned secondary analysis of tolerability, health status, and acceptability of switching to a monthly LA regimen has been performed.
Methods: Participants who were virologically suppressed for >6 months on an oral regimen of 2 NRTIs + 1 INSTI, NNRTI, or PI were randomly assigned (1:1) to continue CAR or switch to the LA arm. The LA arm received oral CAB + RPV once daily for 4 weeks to assess tolerability prior to monthly CAB LA + RPV LA IM injections. Secondary objectives included treatment satisfaction (HIV-Treatment Satisfaction Questionnaire), acceptability of treatment (general acceptance domain of ACCEPT), and health status (SF-12). Tolerability and acceptability of injections (Perception of Injections (PIN)) was assessed in the LA arm only.
Results: 616 participants were randomized and received treatment. The median age was 42 years with 5.4 years of previous treatment; 203 were women (33%). Participants in the LA group showed greater improvement from baseline in treatment satisfaction at Week 44 compared to CAR (mean +6.12 vs +0.44; p < 0.001), along with greater acceptance of treatment at Week 48 (mean +13.7 vs +3.0; p< 0.001). Overall, 94% and 66% of participants “were satisfied to continue their treatment” in the LA and CAR arms, respectively. There were no differences between LA and CAR arms in health status through Week 48. While 231 (75%) participants in the LA arm had injection site pain, 86% reported their pain as “totally” or “very” acceptable on the “Acceptability of ISRs” in the PIN at Week 48.
Conclusions: In addition to demonstrating CAB + RPV LA was non-inferior to CAR, the LA arm reported higher levels of treatment satisfaction, greater willingness to continue therapy, and increased acceptance of treatment. These results indicate monthly CAB + RPV LA may be an important treatment option for virologically suppressed PLHIV who want an alternative to daily oral therapy.