Abstract
In 2022, 20 million women globally were living with HIV, yet they remain underrepresented in clinical trials, including those for antiretroviral treatments (ART). This study assesses the safety and efficacy of the long-acting cabotegravir-rilpivirine (CAB-RPV) regimen in a cohort of 54 women living with HIV (WLWH) over 24 weeks. A retrospective cohort study from the Sardinian HIV Network and Sicilian HIV Cohort (SHiNe-SHiC) included WLWH who switched to CAB-RPV. Primary objectives were achieving and maintaining HIV RNA levels <50 copies/mL at 24 weeks. Secondary objectives included treatment safety, durability, and reasons for discontinuation. Data on demographics, viro-immunological markers, lipid profiles, and treatment interruptions were analyzed. Of 54 WLWH, 46 reached 24 weeks. The median age was 50 years. A total of 71.8% transitioned from dolutegravir (DTG) regimens. Virological suppression was 97.8% at baseline and 95.5% at 24 weeks. Significant increases in the CD4/CD8 ratio (p = 0.0076) and decreases in serum creatinine levels (p = 0.0109) were observed. Cholesterol, triglycerides, ALT, and AST levels remained unchanged. The CAB-RPV regimen demonstrated significant virological and immunological efficacy and safety in women living with HIV over 24 weeks. Notably, the improvement in the CD4/CD8 ratio and the increase in the percentage of women achieving target not detected (TND) status highlight the regimen's effectiveness. These findings emphasize the importance of gender-focused research in HIV treatment and the need for equitable access to effective treatment options for women, which is crucial for global efforts to eliminate HIV.