CABO-CHANCE study: A real-life world study of Cabotegravir plus Rilpivirine long-acting intramuscular in ART-experienced people with HIV.

Abstract

BACKGROUND: This study of people with HIV (PWH) receiving CAB + RPV LAI evaluated its effectiveness, safety, and impact on inflammatory markers, body fat/lean mass distributions, quality of life, sleep, health satisfaction, and stigma experience over 1 y. METHODS: A prospective, longitudinal, multicentre study was conducted in 15 hospitals and enrolled between June 2023 and January 2024. It included virologically suppressed PWH (HIV-1 RNA <50 c/mL for ?6 months) switched from oral antiretroviral therapy to CAB + RPV LAI. Anthropometrics, CD4/CD8 counts, viral load, creatinine clearance, lipid levels, and inflammatory markers were recorded at baseline and 12, 28, 52 weeks. Patient-reported outcomes were gathered using the WHOQOL-HIV-BREF, HIV stigma scale for use in Spain, Pittsburgh Sleep Quality Index, and questionnaires on health satisfaction and adverse events. A subpopulation underwent to whole-body dual energy X-ray absorptiometer (DEXA). RESULTS: Among 269 PWH (mean age 45.6 y; 89.2% male), 240 completed 52-week follow-up, 14 (5.2%) were lost to follow-up, six (2.2%) withdrew consent, 5 (1.9%) were discontinued for adverse events, and one (0.4%) had virological failure (week 12). Snapshot effectiveness was 88.8% (intention-to-treat) and 97.5% (per-protocol). No oral bridging was required. CD4/CD8 ratio (P = 0.0001) and creatinine clearance (P = 0.0001) increased, d-dimer decreased at week 12 (P = 0.001), and BMI modestly increased (P = 0.046). No changes in total/regional fat or lean mass by DEXA (n = 56). Stigma (P = 0.029) and adverse events (P = 0.001) improved. CONCLUSIONS: In this real-world cohort, CAB + RPV LAI was highly effective and safe, was associated with a possible favourable immunologic response, a transient reduction in inflammation, and reduced perceived stigma over 1 y.