Efficacy and safety of dolutegravir plus lamivudine for patients with late presentation of HIV-1 infection: a retrospective real-world cohort study in Southwest China

Qing Wang¹Xiaoxin Xie²Yanhua Fu²Xiaoyan Yang²Lin Gan²Shujing Ma²Pengzhu Jiao¹Muli Wu¹Jun Li¹Hai Long^2*

• ¹School of Public Health, Guizhou Medical University, Guiyang, China
• ²Guiyang Public Health Clinical Center, Guiyang, China

Background: Evidence regarding the use of dolutegravir plus lamivudine (DTG + 3TC) among patients with HIV infection who present late remains limited. This study aimed to evaluate the effectiveness and safety of DTG + 3TC therapy in patients with late presentation in Southwest China. Methods: This single-center, retrospective cohort study included patients with late presentation who initiated DTG + 3TC antiretroviral therapy (ART) between January 2020 and July 2023 (N=176). Changes in immunologic and metabolic parameters as well as liver and kidney function, were assessed. The primary endpoint was the proportion of participants with HIV-1 RNA <50 copies/mL at week 48. Late presentation was defined as CD4 <350 cells/μL or the presence of AIDS-defining conditions. Results: At weeks 24 and 48, 83.0% (146/176) and 90.9% (160/176) of the patients achieved HIV-1 RNA levels <50 copies/mL, respectively. At week 48, the median CD4 count increased by 139.5 cells/μL (120.5–158.5), and the CD4/CD8 ratio increased by 0.2 (0.1–0.3) (P < 0.001). No patient discontinued treatment owing to adverse events during the observation period. Conclusion: DTG + 3TC demonstrated high virologic efficacy and good tolerability in patients with late presentation. However, the regimen may be associated with an increase in lipid levels and weight, highlighting the need for regular monitoring.