Cabotegravir+rilpivirine long-acting every 2 months in a real-world setting: 24-month outcomes in people with HIV-1.

OBJECTIVE

To describe Month (M) 24 outcomes following switch to cabotegravir plus rilpivirine long-acting (CAB+RPV LA) in the CARLOS study.

DESIGN

A noninterventional, 3-year, multicenter study.

METHODS

M24 effectiveness outcomes included virologic suppression (HIV-1 RNA <50 c/ml), nonresponse (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 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.

CONCLUSION

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.