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배경 Cabotegravir (CAB) and rilpivirine (RPV) is the first guideline-recommended complete long-acting (LA) regimen for the maintenance of HIV-1 virologic suppression. In Phase 3 studies, oral CAB+RPV given once daily was utilized as an oral lead-in (OLI) for ≥4 weeks prior to initiating LA dosing to assess in- dividual safety and tolerability. The FLAIR extension phase demonstrated that initiating CAB+RPV direct-to-injection (DTI) had comparable safety, tolerability, efficacy, and pharmacokinetics compared with initiating with an OLI, offering a practical treatment simplification strategy. This post hoc analysis com- pares the safety of CAB+RPV during the OLI to LA administration periods across the Phase 3 program. 방법 Week 48 data from participants naive to CAB+RPV in the FLAIR, ATLAS, and ATLAS-2M studies were pooled. Safety outcomes were summarized separately during OLI and LA periods for those randomized at baseline to CAB+RPV, and also for those switching from oral comparator to CAB+RPV (either via DTI or OLI) during the FLAIR extension phase (Week 100-Week 124). 결과 1245 participants were in cluded in the pooled population; 918 and 327 received CAB+RPV LA Q4W and Q8W following an OLI, respectively. Further, 232 FLAIR extension-switch participants received CAB+RPV LA Q4W, either DTI (n=111) or following an OLI (n=121). The OLI period was well tolerated, with few Grade 3/4 AEs (1%, n=15/1245), serious AEs (<1%, n=9/1245), or AEs leading to withdrawal (<1%, n=10/1245); after continuing to LA therapy, AE rates were comparable between participants electing to receive OLI or DTI (Figure). No drug hypersensitivity reactions or other serious AEs occurred during the 4-week OLI that prohibited transition to LA therapy. 결론 A 4-week OLI of CAB+RPV was well tolerated in >1200 participants across the Phase 3 program. The safety profile of CAB+RPV LA dosing was similar regardless of whether participants received OLI or proceeded DTI, supporting optional CAB+RPV DTI as a simplification strategy. Data included in this abstract have been previously presented in full at the 18th European AIDS Conference; October 27-30, 2021; Virtual & London, UK; Poster PE2/75. [ABSTRACT FROM AUTHOR]