Temporal trends and clinical outcomes of antiretroviral therapy initiation and regimens in treatment-naive people with HIV: A real-world study at a tertiary specialist hospital in Beijing, China

Abstract Background: The World Health Organization and international treatment guidelines recommend rapid initiation of antiretroviral therapy (ART) for all treatment-naive (TN) people living with human immunodeficiency virus (HIV) (PLWH). However, data on temporal trends and clinical outcomes of ART initiation and regimen selection among TN PLWH remain limited in China. This study is designed to evaluate the real-world effectiveness of contemporary treatment strategies within the Chinese context. Methods: We conducted a retrospective study of 1460 TN PLWH who initiated ART between January 2021 and December 2023 at Beijing Ditan Hospital. Data on sex, age, initiation time, ART regimens, CD4 counts, and HIV viral load were collected. Initiation time was categorized based on the time from diagnosis to ART initiation: same-day initiation (0 days), rapid initiation (1 – 7 days), regular initiation (8 – 30 days), and delayed initiation (> 30 days). The main endpoint was the rate of PLWH with virological suppression (HIV-1 RNA < 40 copies/mL) during the study period. Additionally, the durability of ART regimens and the CD4 T-cell count recovery were also evaluated. Factors associated with regimen durability were assessed using univariate and multivariate Cox proportional hazards models. Generalized Estimating Equations (GEE) were used to identify factors associated with virological suppression among TN PLWH. Results: From 2021 to 2023, the proportion of patients with same-day initiation and that of patients with rapid initiation significantly increased, rising from 8.4% (55/656) to 14.0% (69/493) and from 49.5% (325/656) to 57.6% (284/493), respectively ( P < 0.001). Furthermore, 32.9% (46/140) and 36.3% (269/741) of PLWH who underwent same-day and rapid initiation, respectively, chose initial regimens containing two nucleoside reverse transcriptase inhibitors plus a non-nucleoside reverse transcriptase inhibitor. A representative regimen was efavirenz, lamivudine, and tenofovir disoproxil fumarate (EFV+3TC+TDF). All patients achieved a viral suppression rate of over 95.0% at the 24- and 36-month follow-up visits. In TN PLWH who adhered to initial regimens, GEE analysis of virological suppression factors showed both bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) and dolutegravir/lamivudine (DTG/3TC) were non-inferior to EFV+3TC+TDF (odds ratio [OR] = 1.34, 95% confidence interval [CI]: 0.75 – 2.39, P = 0.318; OR = 1.92, 95% CI: 0.54 – 6.80, P = 0.311, respectively). Moreover, BIC/FTC/TAF and DTG/3TC were associated with a lower likelihood of regimen switching, with hazard ratios of 0.35 ( P < 0.001) and 0.39 ( P = 0.004). Besides, BIC/FTC/TAF achieved CD4 T cell counts above 350 cells/μL significantly earlier ( P = 0.015). Conclusion: Our findings revealed the positive trend in rapid initiation in China and several challenges in clinical practice. More targeted interventions are needed to promote the use of BIC/FTC/TAF and DTG/3TC, enhance the accessibility, and ultimately improve health outcomes for PLWH.