Use of long-acting cabotegravir and rilpivirine in people living with HIV: A prospective observational cohort study.

OBJECTIVES

Cabotegravir and rilpivirine long-acting (CAB+RPV LA) is a novel switch strategy for people living with HIV. Our aim was to identify factors associated with therapeutic failure (TF) and virological failure (VF).

METHODS

We conducted a single-centre prospective cohort study. We reviewed all people living with HIV who initiated CAB+RPV LA between 14 February 2023 and 6 May 2025 in the hospital. Reasons for treatment discontinuation (VF, toxicity, poor adherence, death, pregnancy, transfer to another centre or oral bridging) were analysed, as well as virological effectiveness and the emergence of resistance mutations. Safety, adherence and overall regimen durability were also evaluated. The proportion of patients with HIV-RNA < 50 copies/mL at months 1, 7 and 13 was analysed using intention-to-treat (ITT) and on-treatment (OT) approaches.

RESULTS

CAB+RPV LA was administered to 35% of the hospital's cohort (151/429). Of the 151 patients, 80% were male, with a median age of 40 years. A total of 116 patients reached 13 months of treatment. After a median follow-up of 18.8 months (interquartile range [IQR]: 11-23.7), 28 (18.5%) patients discontinued treatment, 3 (2%) of them due to VF (one with resistance mutations to both rilpivirine and cabotegravir). The proportions of patients with HIV-RNA < 50 copies/mL at months 1, 7 and 13 were 96%, 91% and 85% (ITT) and 96%, 95% and 93% (OT), respectively. Reasons for discontinuation included VF (2%), adverse events (4%), poor adherence (3%), transfer to another hospital (5%), oral bridging (4%) and difficulty attending appointments (1%). The modified therapeutic failure rate (excluding oral bridging and transfers) was 7.42 (95% confidence interval [CI]: 4.3-12.0) per 100 person-years.

CONCLUSIONS

CAB+RPV LA appears to be an effective, safe and durable option for a switch strategy.