Efficacy and Renal Safety of Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) Among People Living With HIV With Early or Mild Renal Injury: A Real World Retrospective Study in China

Renal dysfunction is common in people living with HIV because of HIV infection and/or adverse effects of some antiretroviral therapy (ART) regimens. Our study aimed to investigate the efficacy and safety of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) among people living with HIV (PLWH) with early or mild renal injury after 48 weeks of treatment initiation. We enrolled 266 ART-naïve and 39 ART-experienced PLWH who received care at Beijing Ditan Hospital from January 2022 through December 2023. All participants presented with early or mild renal injury at baseline. After 48 weeks of BIC/FTC/TAF treatment, 99.6% of ART-naïve and 100% of ART-experienced participants achieved viral suppression. Serum creatinine levels increased, and the estimated glomerular filtration rate decreased significantly at week 24, with both parameters remaining stable at week 48. Urinary protein/creatinine, urine albumin/creatinine and specific urinary proteins (including urinary protein quantification, urinary microalbumin, α1-microglobulin and β2-microglobulin) significantly decreased after 48 weeks of treatment (all P <0.001). The proportion of patients with chronic kidney disease at the A2 stage decreased from 2.6% to 0. Blood lipid profiles increased significantly at week 24 and remained stable through week 48 in ART-naïve PLWH. In conclusion, BIC/FTC/TAF was associated with stable renal function and reduced proteinuria in ART-naïve and ART-experienced PLWH with early or mild renal injury. Nevertheless, a single-arm observational design precludes causal attribution of the observed improvements in renal biomarkers to the direct effects of the BIC/FTC/TAF regimen alone. Larger, longer-term, controlled studies are warranted to validate our findings.