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Introduction <p>Dolutegravir (DTG) plus lamivudine (3TC) is one of the preferred treatment regimens for HIV, yet evidence remains limited for people living with HIV (PLWH) with high baseline viral load. This study aims to evaluate the effectiveness of DTG/3TC in treatment-naive PLWH with baseline viral load &gt; 500,000&#xa0;copies/mL in China.</p> Methods <p>In this real-world multicenter cohort study, PLWH with baseline viral load (VL) &gt; 500,000&#xa0;copies/mL who initiated DTG/3TC were recruited across 18 clinical sites in China. Matched participants from the same sites with lower baseline VL were also included as a control group. Participants were followed for 48&#xa0;weeks. The primary endpoint was virological suppression (HIV-1 RNA &lt; 50&#xa0;copies/mL) at week&#xa0;48 using the US Food and Drug Administration snapshot algorithm.</p> Results <p>Of the 375 PLWH enrolled, 150 were classified into the high VL group and 225 into the low VL group. Baseline median HIV-1 RNA was 5.99 and 5.07&#xa0;log<sub>10</sub>&#xa0;copies/mL, respectively. At week&#xa0;48, virologic suppression was achieved in 88.0% (95%&#xa0;CI 82.8–93.2%) of the high VL group and 92.0% (95%&#xa0;CI 87.9–96.2%) of the low VL group (<i>P</i> = 0.233); 7.5% and 4.0% of participants in the high and low VL groups had plasma HIV-1 RNA ≥ 50&#xa0;copies/mL, respectively. Median CD4 increases from baseline to week&#xa0;48 were 153.5 and 147.0&#xa0;cells/μL in the high and low VL groups, respectively (<i>P</i> = 0.408). Safety profiles were comparable, with one grade&#xa0;3 adverse event in each group.</p> Conclusions <p>DTG/3TC showed favorable virological and safety outcomes in treatment-naive PLWH with baseline HIV-1 RNA &gt; 500,000&#xa0;copies/mL, suggesting that it may be a viable option for PLWH with high baseline viral load.</p> Trial Registration <p>Chinese Clinical Trial Registry: ChiCTR2300074854.</p>

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Real-World Multicenter Study on the Effectiveness of Dolutegravir Plus Lamivudine in Treatment-Naive People Living with HIV with Baseline HIV-1 RNA > 500,000 Copies/mL

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  • 发表日期：

    2026年6月19日

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  • Bichen Xue,
  • Rui Jiang,
  • Yanyun Dou,
  • Jinglan Lai,
  • Wei Zou,
  • Yingjie Fang,
  • Weiguang Feng,
  • Fuyan Sun,
  • Chunhui Yan,
  • Tao Guo,
  • Jian Ao,
  • Ke Hong,
  • Yuhong Xiong,
  • Qi Chen,
  • Chunhua Xu,
  • Guangyong Xu,
  • Xiaoshui Lu,
  • Yuanyuan He,
  • Yirong Shi,
  • Xiaoyan Yang,
  • Yahong Chen,
  • Jiuyun Luo,
  • Baofang Yang,
  • Yanhua Fu,
  • Fang Zhao,
  • Jin Li,
  • Jun Chen

摘要

Introduction

Dolutegravir (DTG) plus lamivudine (3TC) is one of the preferred treatment regimens for HIV, yet evidence remains limited for people living with HIV (PLWH) with high baseline viral load. This study aims to evaluate the effectiveness of DTG/3TC in treatment-naive PLWH with baseline viral load > 500,000 copies/mL in China.

Methods

In this real-world multicenter cohort study, PLWH with baseline viral load (VL) > 500,000 copies/mL who initiated DTG/3TC were recruited across 18 clinical sites in China. Matched participants from the same sites with lower baseline VL were also included as a control group. Participants were followed for 48 weeks. The primary endpoint was virological suppression (HIV-1 RNA < 50 copies/mL) at week 48 using the US Food and Drug Administration snapshot algorithm.

Results

Of the 375 PLWH enrolled, 150 were classified into the high VL group and 225 into the low VL group. Baseline median HIV-1 RNA was 5.99 and 5.07 log10 copies/mL, respectively. At week 48, virologic suppression was achieved in 88.0% (95% CI 82.8–93.2%) of the high VL group and 92.0% (95% CI 87.9–96.2%) of the low VL group (P = 0.233); 7.5% and 4.0% of participants in the high and low VL groups had plasma HIV-1 RNA ≥ 50 copies/mL, respectively. Median CD4 increases from baseline to week 48 were 153.5 and 147.0 cells/μL in the high and low VL groups, respectively (P = 0.408). Safety profiles were comparable, with one grade 3 adverse event in each group.

Conclusions

DTG/3TC showed favorable virological and safety outcomes in treatment-naive PLWH with baseline HIV-1 RNA > 500,000 copies/mL, suggesting that it may be a viable option for PLWH with high baseline viral load.

Trial Registration

Chinese Clinical Trial Registry: ChiCTR2300074854.