Long‐acting cabotegravir and rilpivirine in people with HIV and obesity: Real‐world outcomes from the RELATIVITY cohort

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Abstract Introduction Long‐acting injectable cabotegravir and rilpivirine (LAI CAB + RPV) is a well‐established regimen for people with HIV (PWH) that offers high efficacy and tolerability. However, data are limited for obese individuals with a body mass index (BMI) ≥ 30 kg/m 2 , which may represent a potential risk factor for virologic failure (VF). Methods We conducted a multicentre, ambispective study (RELATIVITY cohort, Spain) of virologically suppressed PWH with BMI ≥ 30 kg/m 2 who switched to LAI CAB + RPV. This study characterized this population and evaluated the factors associated with virologic outcomes, tolerability and adherence using Kaplan–Meier analysis. Results Among the 3,203 individuals recruited in the RELATIVITY cohort, 57 were excluded due to detectable HIV RNA at the time of switching to LAI CAB+RPV, and 3,146 were finally included, all of whom had HIV RNA levels <50 copies/mL at baseline. BMI data were available for 2,736 participants, of whom 362 (11.5%) had a BMI ≥30 kg/m 2 and 2,374 had a BMI <30 kg/m 2 . Obese participants were older (median age 48 vs. 45 years) and included a higher proportion of women (21.9% vs. 13.7%). Comorbidities included dyslipidaemia (36.7%), hypertension (22.9%), diabetes (11.6%), chronic lung disease (6.4%), MASLD (5.5%) and coronary disease (3.3%). The main reasons for switching included quality‐of‐life improvement (49.2%), patient requests (35.4%), and therapy simplification (26%). VF was rare, occurring in 1.1% of obese individuals and 0.6% of non‐obese participants over a median follow‐up of 13.8 months ( p = 0.284). Emergent resistance mutations were detected in 2/4 VF in obese participants. The discontinuation rate was low across all study groups. Among participants with obesity, local adverse events accounted for 1.9% of discontinuations, systemic adverse events for 0.8%, and other causes for 3.9% of discontinuations. In this subgroup, 72.9% of injections were administered using a 38‐mm needle. Injection adherence was excellent, with 83.1% of participants with obesity achieving full (100%) coverage and an additional 16.3% maintaining 90–99.9% coverage. Conclusions In this real‐world cohort, LAI CAB + RPV was safe and effective in PWH with obesity, with comparable VF rates, tolerability, and adherence to participants without obesity. These findings support the use of LAI CAB + RPV across diverse PWH populations, including those with a BMI ≥ 30 kg/m 2 , and highlight its feasibility in PWH with multiple comorbidities.

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