# Real-world experience of Dolutegravir/Lamivudine for rapid initiation of antiretroviral therapy among treatment-naïve HIV-1-infected adults in China: a multicenter retrospective study

## TL;DR

This study shows that starting HIV treatment with Dolutegravir/Lamivudine quickly after diagnosis is as effective and safe as starting later.

## Contribution

The study provides real-world evidence supporting rapid initiation of Dolutegravir/Lamivudine in treatment-naïve HIV patients.

## Key findings

- Rapid ART initiation with DTG/3TC showed similar virological suppression rates compared to non-rapid initiation.
- CD4 count increases were comparable between rapid and non-rapid groups after 48 weeks.
- No significant differences in liver, renal, or lipid function changes were observed between groups.

## Abstract

Experience with Dolutegravir/Lamivudine (DTG/3TC) for rapid initiation of antiretroviral therapy (ART) in newly diagnosed people living with HIV (PLWH) remains scarce. We conducted a study to evaluate the effectiveness and safety of DTG/3TC for rapid ART.

This retrospective, real-world study was conducted among treatment-naïve PLWH at three centers in Beijing, Nanjing, and Qingdao. Participants were stratified into the rapid group (≤7 days) and the non-rapid group (>7 days) based on the time from HIV diagnosis to ART initiation. The primary endpoint was the rate of virological suppression (VS) at week 48, which was assessed using both intention-to-treat (ITT) and per-protocol (PP) analyses in accordance with the Food and Drug Administration (FDA) Snapshot algorithm.

A total of 145 participants were enrolled between February 2022 and October 2023 (57 in the rapid group and 88 in the non-rapid group). The median time for the two groups to ART initiation was 4.0 (3.0, 5.0) and 17.0 (12.3, 25.5) days, respectively (P < 0.001). No significant baseline differences were observed between the two groups. ITT analysis showed that the 48-week VS rates were 93.0% [95% confidence interval (CI): 86.1%–99.8%] in the rapid group and 90.9% (95% CI: 84.8%–97.0%) in the non-rapid group (P = 0.765). Multivariable logistic regression analysis, adjusted for age, baseline CD4 counts, baseline VL, and treatment initiation pattern, confirmed that rapid ART was not significantly associated with VS at week 48 [adjusted odds ratio (OR) = 1.100, 95% CI: 0.291–4.164, P = 0.888]. Subgroup analyses further demonstrated consistent results: no significant differences in VS rates were detected across subgroups (all P > 0.05). The median increases in CD4 counts from baseline at week 48 were 232 and 243 cells/μL in the rapid and non-rapid groups, respectively (P = 0.951). Throughout the 48-week follow-up period, changes in liver function, renal function, and lipid levels from baseline did not differ significantly between the two groups.

Our study provides clinical evidence supporting the effectiveness and safety of DTG/3TC for rapid ART in treatment-naïve PLWH, with outcomes comparable to those of non-rapid initiation.