Effectiveness, Sex Differences, and Patient Experience in Real-World Use of Long-Acting Cabotegravir and Rilpivirine: Results from a Prospective Study.

INTRODUCTION

Long-acting intramuscular cabotegravir plus rilpivirine (LA-CAB/RPV) administered every 2 months (Q2M) has been available in Spain since January 2023 as a switch strategy for HIV treatment. We evaluated characteristics, effectiveness, tolerability, and acceptance, including patient-reported outcomes, stratified by sex in people with HIV switching to LA-CAB/RPV.

METHODS

Observational, prospective, cohort study in Hospital Clínic of Barcelona, Spain. Participant characteristics according to sex at birth and treatment effectiveness [HIV-RNA < 50 copies/mL by on treatment (OT), modified intention-to-treat (mITT), and intention to-treat (ITT) analyses] were evaluated. Self-administered electronic questionnaires were collected.

RESULTS

From February 2023 to February 2025, 57/741 (8%) women and 684/741 (92%) men started LA-CAB/RPV, compared to 816/5901 (14%) women that continued with other antiretroviral therapy (ART) (p < 0.001) in our cohort. Women were older, had longer time since HIV diagnosis and on ART, lower nadir CD4, and were more frequently Spanish-born than men. Effectiveness by OT, mITT, and ITT in the 461 participants (29 women and 432 men) who reached week 52 of follow-up was 96%, 83%, and 83% and 99%, 92%, and 89%, respectively, without significant differences. There were 8 (1.7%) confirmed virological failures and 40 (9%) discontinuations with no significant differences by sex. Acceptance, tolerability of injections, and HIV medication burden globally improved during follow-up. Women reported more medication burden and disclosure worries than men.

CONCLUSIONS

Compared to our general cohort, proportionally fewer women than men switched to LA-CAB/RPV. Effectiveness, adherence, tolerability, and acceptance were high without significant differences by sex. In this study, women expressed more frequent disclosure issues and showed significantly different baseline characteristics compared to men, highlighting the importance of sex-disaggregated data analysis. These results should be confirmed in larger studies.