Clinical Outcomes and Perspectives of People With Human Immunodeficiency Virus Type 1 Twelve Months After Initiation of Long-acting Cabotegravir and Rilpivirine in an Observational Real-world US Study (BEYOND).

Background: Long-acting cabotegravir plus rilpivirine (CAB + RPV LA) administered monthly or every 2 months is recommended by treatment guidelines for maintenance of virologic suppression in people with human immunodeficiency virus type 1 (HIV-1). In clinical trials, CAB + RPV LA demonstrated noninferiority versus United States (US) Food and Drug Administration-approved daily oral therapy, and outcomes in real-world settings can supplement these results. We present month 12 results of BEYOND. Methods: BEYOND is an ongoing, 2-year, multicenter, prospective, observational real-world study of adults initiating CAB + RPV LA in the US. Key outcomes included reasons for initiating, virologic outcomes, adherence, and patient-reported outcomes related to treatment satisfaction and treatment challenges at baseline and month 12. Results: In total, 308 participants (median age, 45 years; 83% identified as male; 39% identified as Black) initiated CAB + RPV LA most commonly because of treatment fatigue, adherence anxiety with daily oral therapy, and/or convenience. Of participants with baseline viral load data, 97% (194/200) had a viral load <50 copies/mL for their most recent test reported at month 12. Mean treatment satisfaction scores increased significantly from baseline to month 12 and 97% (223/229) of participants preferred LA versus oral treatment at month 12. Proportions of participants reporting "always" or "often" experiencing challenges related to HIV-1 treatment (fear of disclosure, adherence anxiety, reminder of HIV-1 status, and feeling stigmatized) decreased from baseline to month 12. Conclusions: Month 12 results from the real-world BEYOND study support the effectiveness of CAB + RPV LA for maintenance of virologic suppression and as a preferred treatment option for people with HIV-1.