Objective: To describe Month (M) 24 outcomes following switch to cabotegravir plus rilpivirine long-acting (CAB+RPV LA) in the CARLOS study. Design: Non-interventional, 3-year, multicenter study. Methods: M24 effectiveness outcomes included virologic suppression (HIV-1 RNA <50 c/mL), non-response (HIV-1 RNA ≥50 c/mL), and protocol-defined virologic failure (PDVF; two consecutive HIV-1 RNA ≥200 c/mL, or a single HIV-1 RNA ≥200 c/mL followed by treatment discontinuation for any reason). Additional outcomes included dosing window adherence and patient-reported outcomes. Results: In total, 351 people living with HIV were included in the analysis at M24. Overall, 94% (n = 3464/3676) of CAB+RPV LA injections were administered before or within the ±7-day dosing window; 6% (n = 212/3676) occurred late. At M24, 77% (n = 272/351) of participants maintained virologic suppression, 20% (n = 70/351) discontinued or had no data in window with last observation carried forward <50 c/mL, 0.6% (n = 2/351) had a single HIV-1 RNA ≥50 c/mL, and 2% (n = 7/351) had PDVF. There was a low rate of discontinuation due to injection site reactions. A statistically significant increase in treatment satisfaction total score was observed from baseline to M24 (mean/maximum score standard deviation, 55.0/66 10.0) and 61.0/66 7.1, respectively; mean change, +6.0; p<0.001; n = 233), meeting the threshold for minimum clinically important difference. Conclusions: In this real-world study, CAB+RPV LA maintained high rates of virologic suppression, was well tolerated, and led to increased treatment satisfaction through 24 months following switch. These data reinforce the findings of the Phase 3/3b CAB+RPV LA program and support the continued use of CAB+RPV LA in routine clinical care.
Wyen et al. (Tue,) studied this question.