Abstract Background: Long-term outcome data from real-world studies on drug implementation CBictegravir emtricitabine tenofovir alafenamide fumarate(BIC/TAF/FTC) regimen in the treatment of elderly patients with HIV/AIDS data are still limited. This study evaluated the real-world effectiveness and safety of BIC/TAF/FTC in people living with HIV (PLHIV) in Southwestern China. Methods: This was an observational, single-center, retrospective study that enrolled antiretroviral therapy (ART)-naïve (n = 149) and ART-experienced patients with HIV (n = 143) between January 2021 and April 2024. Analysis of virological efficacy and safety, the main end point is the viral suppression rate of HIV RNA < 50 copies/ml at 48 weeks, and the change of CD4 cell count, CD4/CD8 ratio, body weight, blood lipid and safety are secondary results. Results: The proportion of treatment-naïve and ART-experienced PLHIV with a VL <50 copies/mL at 48 weeks was 90.6% and 92.9%, respectively. The CD4 count increased significantly by 102.0cells/μL(P＜0.001) and 51.0cells/μL(P＜0.001), in the ART-naïve and ART-experienced patients, respectively. During the follow-up of 149 ARTnaïve and 143ART-experienced patients using BIC/FTC/TAF, The estimated incidence of drug-related adverse events was 9.4% and 5.6%, respectively. however, these events did not lead to drug withdrawal. Conclusions: BIC/TAF/FTC can achieve better antiviral efficacy and immune recovery in newly treated and treated patients. However, in terms of safety, BIC/TAF/FTC has an impact on blood lipids in elderly patients. It is suggested that elderly patients who use this scheme should closely detect the changes of their lipid profiles. Keywords: Efficacy and safety; Bictegravir/emtricitabine/tenofovir alafenamide fumarate; Elderly patients with HIV/AIDS.

Introduction Co-infection with tuberculosis (TB) is the leading cause of death in individuals infected with human immunodeficiency virus (HIV)-1. Dolutegravir and lamivudine (DTG+3TC) has recently been recommended as the preferred first-line regimen for the treatment of new and treatment-experienced HIV-infected patients. The primary objective of this study was to determine the efficacy and safety of DTG 50 mg + 3TC 300 mg in HIV-positive antiretroviral therapy (ART)-naïve patients with TB who were receiving a rifampicin- or rifabutin-based treatment regimen, and to characterize viral suppression rates at week 48. Methods A single-center retrospective observational case series, spanning January 1, 2021 to March 1, 2023, was conducted in Guiyang Public Health Treatment Center. The outcomes of interest were successful TB treatment, viral load suppression, and immunological and biochemical indexes. Results All PWH had at least 48 weeks of follow-up, and all TB treatments were successful. A total of seven PWH (100%) achieved viral suppression (VL <50 copies/mL) from a baseline VL greater than 500,000 copies/mL. Among the PWH who started DTG+3TC after the initiation of the rifabutin-based anti-TB regimen, all achieved viral suppression by week 24, except for the non-suppressed PWH. CD4+ T-cell counts were greatly improved after antiretroviral treatment. The CD4+/CD8+ ratio increased by 0.38 (P < 0.001). Serum creatinine, total cholesterol, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol levels significantly increased (P = 0.054, P = 0.015, P < 0.001, and P < 0.05, respectively). There were no significant changes in body weight, alanine aminotransferase, aspartate aminotransferase, chronic kidney disease epidemiology collaboration-based serum creatinine, or triglyceride levels from baseline to week 48 (P > 0.05). No serious adverse events were observed. Conclusion This case series preliminarily validated the efficacy of DTG+3TC when combined with rifabutin-based anti-TB regimens in patients with TB and HIV.