Background
This study aimed to focus on sex-based characteristics, patient reported outcomes (PROs) and effectiveness in people with HIV switching to long-acting cabotegravir-rilpivirine (LA-CAB/RPV) administered Q2M in Hospital Clínic of Barcelona, Spain.
Methods
People starting LA-CAB/RPV were invited to participate in an observational, prospective study approved by the local Ethical Committee. Clinical information was routinely collected, PROs were self-administered through electronic questionnaires. Participant characteristics, treatment effectiveness [HIV-RNA <50 copies/mL by on treatment (OT), modified intention-to-treat (mITT), and intention to-treat (ITT)], and PROs were analyzed focusing on sex-at-birth based differences.
Results
From 2Feb2023 to 2Jul2024, 611 participants of 6477 in active follow up (9%) started LA-CAB/RPV, and 587 accepted to participate, 547 (93%) men and 40 (7%) women at birth, compared to 4862 (84%) men and 909 (16%) women that continued with other ART (p < 0.001). Women were older, had longer time since HIV diagnosis, longer time on ART, had higher last-CD4 count but lower nadir-CD4, and were more frequently Spanish-born than men both in LA-CAB/RPV group (Table) and in general cohort (not shown). Women had more previous virological failures but no differences in number of historical mutations. Effectiveness by OT, mITT and ITT in the 373 participants on LA-CAB/RPV who reached week28 of follow up was 100%, 92%, and 90% in women and 97%, 93%, and 90% in men without significant differences. Injections were administered on time in 96% (men) and 97% (women). There were 5 (1%) confirmed virological failures, all in men, and all but one with low level viremia (VL <200 cp/mL). No significant differences in reason for switching to LA-CAB/RPV nor in treatment acceptance (ACCEPT questionnaire) were observed between men and women. No differences in life satisfaction and HIV medication relationship domains of HIV/AIDS-Targeted Quality of Life (HAT-QoL) questionnaire were noted, nonetheless women expressed more frequent disclosure issues than men (p <0.001). No relevant differences were observed in injection site reactions nor in Perception of Injection questionnaire.
Conclusions
Compared to our general cohort, proportionally less women than men switched to LA-CAB/RPV. Baseline characteristics could partially explain this difference, although we cannot exclude prescription biases or other barriers.