Efficacy and protective effects of urinary biomarkers among people with HIV with early or mild renal injury taking Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF): a real world study in China

Objective Our study aimed to investigate efficacy and safety of BIC/FTC/TAF among people with HIV(PWH) with early renal or mild injury after 48-week initiation. Methods A retrospective study conducted to evaluate the efficacy and safety of BIC/FTC/TAF in 278 ART-naïve and 44 ART-experienced PWH who received treatment at Beijing Ditan Hospital from January 2022 to December 2023.. Results 99.6% ART-naïve and 100% ART-experienced PWHs achieved virologically suppressed 48-week of initiation, including 7 ART-experienced PWHs presented NNRTI and 3TC resistance. UP/C, ACR and Urine biomarkers, including UPQ, UMA, α1-MG and β2-MG, were significantly improved after initiation, in which UP/C in ART-naive and -experienced PWH were decreased from 2.97(IQR:1.43 ~ 3.48) to 1.74(IQR:0.80 ~ 1.93) (p < 0.001) and 4.33(IQR:2.31 ~ 5.72) to 1.42 (IQR:0.78 ~ 1.37) (p < 0.001), respectively, the prevalence of CKD A2 (3 ≤ ACR ≤ 30mg/mmol) decreased from 2.6% to 0, the UPQ decreased from 21.66(IQR:10.50 ~ 22.65) mg/dl at baseline to 12.78(IQR:5.80 ~ 14.20)mg/dl at 48-week(p < 0.001), UMA from 44.77 (IQR:14.85 ~ 44.08)mg/L to 24.81(IQR:7.00 ~ 23.00)mg/L(p < 0.001), α1-MG from 16.04(0 ~ 19.43)mg/L to 9.91(0 ~ 13.50)mg/L (p < 0.001), and β2-MG from 1.26 (0.39 ~ 1.26)mg/L to 0.50(0.18 ~ 0.58)mg/L (p < 0.001), respectively. serum creatinine and eGFR presented significantly increased and reduced at 24-week, respectively, and kept stable at 48-week of initiation. Lipid panel also indicated significantly increased at 24-week and maintained stable levels at 48-week of initiation among ART-naive PWHs, while among ART-experienced PWH switching from EVG/c/FTC/TAF, lipid panel showed downward trend. Conclusion BIC/FTC/TAF demonstrated good efficacy and safety in ART-naive and -experienced PWH with early or mild renal injury, and the urinary biomarkers were significantly improved after receiving BIC/FTC/TAF, which indicated its renal protective effect.