Comparative efficacy and safety of dolutegravir/lamivudine versus ainuovirine-based triple therapy in people living with HIV: a real-world cohort study

<title>Abstract</title> <p> Background Optimizing antiretroviral therapy (ART) requires balancing virological efficacy with long-term safety. Evidence comparing two-drug regimens with emerging non-nucleoside reverse transcriptase inhibitor (NNRTI)-based triple regimens in real-world settings remains limited. Methods We conducted a retrospective cohort study including 216 people living with HIV (PLWH) who received either dolutegravir/lamivudine (DTG/3TC) or ainuovirine/lamivudine/tenofovir disoproxil fumarate (ANV/3TC/TDF) at Zhenjiang Third People’s Hospital between January 2019 and January 2026. Participants were followed for at least 12 months. Virological suppression, immunological recovery (CD4⁺ T-cell count and CD4 ⁺ /CD8 ⁺ ratio), and safety outcomes including hepatic, renal, metabolic parameters, body weight, and body mass index (BMI) were assessed. Results At 12 months, virological suppression rates were comparable between the DTG/3TC and ANV/3TC/TDF groups (94.45% vs. 84.45%, P = 0.24). Both regimens resulted in significant immunological improvement, with no between-group differences at study endpoint. The DTG/3TC group showed higher levels of serum creatinine and lipid parameters, including low-density lipoprotein cholesterol(LDL-C), total cholesterol(TC), and non-high-density lipoprotein Cholesterol(non-HDL-C), whereas high-density lipoprotein cholesterol(HDL-C) was also significantly elevated. No significant differences were observed in liver function, body weight, or BMI. Conclusions DTG/3TC and ANV/3TC/TDF demonstrated comparable virological efficacy and similar hepatic safety profiles. However, differences in renal biomarkers and lipid metabolism were observed. These findings highlight the importance of individualized ART selection based on metabolic and renal risk profiles. </p>