Clinical Efficacy and Safety of BIC/TAF/FTC in Elderly HIV‐Infected Individuals in Southwest China: A Retrospective Observation Study

TL;DR

This study shows that BIC/TAF/FTC is effective and safe for elderly HIV patients in China, helping control the virus and improve immune function.

Contribution

The study provides real-world evidence of BIC/TAF/FTC's efficacy and safety in elderly HIV patients with comorbidities and heavy drug use.

Findings

93.1% of ART-naïve and 92.9% of ART-experienced patients achieved viral suppression after 48 weeks.

CD4 cell counts and CD4/CD8 ratios significantly increased in both groups.

Adverse events were reported in 11.7% of ART-naïve and 4.3% of ART-experienced patients.

Abstract

Long‐term outcome data from real‐world studies of the bictegravir emtricitabine tenofovir alafenamide fumarate (B/F/TAF) regimen in the treatment of elderly patients with HIV/AIDS are still limited. This study evaluated the real‐world effectiveness and safety of B/F/TAF in elderly HIV‐infected individuals in southwest China.

This was an observational, single‐center, retrospective study that enrolled antiretroviral therapy (ART)‐naïve (n = 149) and ART‐experienced (n = 143) patients with HIV infection between January 2021 and April 2024. The main endpoint was the viral suppression rate of HIV RNA < 50 copies/ml at 48 weeks, and change in CD4 cell count, CD4/CD8 ratio, body weight, blood lipid and safety were secondary endpoints.

The proportions of ART‐naïve and ART‐experienced HIV‐infected cases with VL < 50 copies/mL at 48 weeks were 93.1% and 92.9%, respectively. CD4 cell counts and CD4/CD8 ratios increased significantly from baseline at 48 weeks (p < 0.001). In the treatment‐naive group, ALT, AST, eGFR, and Glu decreased significantly from baseline at 48 weeks, while body weight, Scr, TC, HDL, and LDL increased significantly. Among patients previously administered ART, eGFR increased significantly from baseline at 48 weeks, while AST, LDL, and Scr decreased significantly; other indicators showed no significant changes from baseline. The incidence rates of adverse events were 11.7% and 4.3% in treatment‐naïve and treatment‐experienced, respectively.

For elderly HIV/AIDS patients, B/F/TAF is a safe option to achieve and maintain virological suppression and immune recovery. In terms of lipid metabolism, the metabolic effects of BIC/FTC/TAF in the treated patients are not significant, and the effects in untreated patients require longer follow‐up.

This study aims to statistically analyze the clinical effectiveness and safety of BIC/FTC/TAF in elderly HIV/AIDS patients in real‐world settings, providing clinical data to optimize ART regimens for this population. We believe that our research has made a great contribution to the literature, because we found that the BIC/FTC/TAF showed good virological efficacy in elderly patients with many comorbidities and heavy drug burden.

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