Effectiveness and Persistence of Long-Acting Injectable Cabotegravir and Rilpivirine in Migrant Individuals Living With HIV in Spain: Substudy of the RELATIVITY Cohort

Abstract

INTRODUCTION: Migrants living with HIV often face high mobility, vulnerability and limited baseline information on HIV-1 genotype or treatment history. We aimed to assess the effectiveness and persistence of long-acting injectable cabotegravir and rilpivirine (LAI CAB+RPV) among migrants in Spain. METHODS: This multicentre cohort study across 58 Spanish hospitals included virologically suppressed adults switching to CAB+RPV LAI before January 2025. Data collection started in June 2023. Baseline characteristics and outcomes were compared by migrant status, and multivariate Cox proportional hazards regression models were fitted to assess factors associated with virological failure (VF) and discontinuation. Propensity score matching (PSM) by gender, age, known genotype and prior VF was employed to control for confounding. RESULTS: Of 3135 participants, 951 (30.3%) were migrants, predominantly from Latin America. Median follow-up was 13.8 months (interquartile range 8.91-19.1). VF occurred in 0.9% of migrants versus 0.5% of Spanish-born individuals (odds ratio 1.89, 95% confidence interval [CI] 0.69-5.03; p = 0.22). In adjusted models, migrant status showed a non-significant trend towards higher VF (adjusted hazard ratio [aHR] 2.16, 95% CI 0.89-5.22; p = 0.079). At 12 months, 95.8% of migrants (461/481) persisted on LAI CAB+RPV treatment versus 98.3% of Spanish-born individuals (1348/1372) (p = 0.005). Discontinuation due to any adverse event was more frequent in migrants (3.3% vs. 1.8%). Migrant status was significantly associated with discontinuation due to both local (aHR 2.63, 95% CI 1.33-5.26; p = 0.005) and systemic adverse events (aHR 3.33, 95% CI 1.45-7.69, p = 0.005). In the PSM cohort (n = 932 per group), migrant status was independently associated with increased risk of VF (aHR 3.51, 95% CI 0.95-12.98, p = 0.045) and discontinuation due to systemic adverse events (aHR 2.88, 95% CI 1.01-8.17, p = 0.047). CONCLUSIONS: Nearly one-third of participants switching to LAI CAB+RPV were migrants. While VF was rare overall, migrants had a significantly higher risk of treatment discontinuation, partly driven by adverse events. These findings highlight the need for closer monitoring and tailored strategies to optimize persistence with LAI regimens in migrant populations.