Abstract Background Females with HIV (FWH) are underrepresented in HIV trials. Pooled data from 5 trials at 48 weeks demonstrated the virological efficacy and safety of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF). We evaluated the safety and efficacy of B/F/TAF in a cohort of 99 FWH, in a real-life setting, at 48 and 96 weeks from the switch. Methods We conducted a multicentric cohort study that included all experienced FWH starting B/F/TAF treatment in the Shine&Shic cohort across six Infectious Disease Centers in Italy. We collected demographic, epidemiological, clinical, and laboratory data at the time of the switch and at 48 and 96 weeks. Informed consent was obtained from all participants. Data were reported as numbers (%), or using median and interquartile range (IQR), as appropriate. We assessed differences between baseline, 48 weeks, and 96 weeks using the Mann-Whitney test. A p-value of less than 0.05 was considered significant. Results We included 99 females with HIV (FWH) in the study, with a median age of 51.9 years (IQR 43.1-57.8) and a duration of HIV infection of 15.1 years (IQR 5.1-24.7). During follow-up, we observed an increase in the percentage of FWH with an undetectable viral load (Figure 1). We noted a significant increase in CD4 cells/mL and in CD4/CD8 ratio at 48 and 96 weeks and no differences in CD8 cell counts (Table 2). Of importance, we observed a significant reductions in total cholesterol and low-density lipoprotein (LDL) at both 48 and 96 weeks. No significant changes were observed in transaminase levels, glucose levels, high-density lipoprotein (HDL), or triglycerides (Table 2). Regarding safety, there was a significant increase in creatinine at 48 and 96 weeks. We registered 9 interruptions of B/F/TAF: 3 due to loss to follow-up, 1 death, 1 switch to long-acting treatment, 1 due to adverse events, and in 3 cases, due to patient’s choice. Conclusion The number of FWH on B/F/TAF under virological suppression increased at 48 and 96 weeks. Furthermore, CD4 T-cell and CD4/CD8 ratio also augmented, underlining an amelioration of the immunological and inflammatory profile. Of note, LDL cholesterol levels significantly decreased overtime. B/F/TAF is virologically and immunologically effective in FWH, in a real-life setting, at 96 weeks from the switch. Disclosures All Authors: No reported disclosures
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