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Background/Objective <p>Despite global gains with dolutegravir (DTG), comparative real-world data from sub-Saharan Africa remain valuable. We compared virological, immunological and tolerability outcomes among ART-naïve adults initiating tenofovir/lamivudine/dolutegravir (TLD) versus tenofovir/lamivudine/efavirenz (TLE) at Tikur Anbessa Specialized Hospital, Addis Ababa, Ethiopia.</p> Methods <p>We performed a hospital-based retrospective comparative study of adults (≥ 15 years) who started first-line TLD or TLE between 1 August 2022 and 25 February 2024 and had ≥ 6 months follow-up with baseline and follow-up CD4 and/or viral-load data. Primary outcome was viral suppression (HIV-1 RNA &lt; 50 copies/mL) at ~ 24/48 weeks; secondary outcome was change in CD4 count. Multivariable logistic and linear regression adjusted for age, sex, baseline CD4 and adherence.</p> Results <p>Among 250 patients (125 TLD, 125 TLE), baseline sociodemographic and clinical characteristics were comparable (mean CD4 308 vs. 311 cells/µL). In bivariate analysis, TLD showed higher odds of viral suppression (COR = 1.78; 95% CI 1.05–3.02; <i>p</i> = 0.033), but after adjustment, there was no statistically significant difference in viral suppression between TLD and TLE (AOR = 1.68; 95% CI 0.91–3.12). Good adherence strongly predicted suppression (AOR = 9.10; 95% CI 3.30–25.10; <i>p</i> &lt; 0.001). Mean CD4 gain was greater with TLD (adjusted B = 40.32 cells/µL; 95% CI 14.76–65.88; <i>p</i> = 0.002). Adverse drug reactions occurred less frequently with TLD (7.2%) than with TLE (17.6%) (χ² = 6.24; <i>p</i> = 0.013).</p> Conclusion <p>In this routine-care Ethiopian cohort, TLD and TLE achieved comparable adjusted virological suppression, but TLD produced larger CD4 gains and fewer adverse events. Strengthening adherence support and earlier ART initiation remain central to optimizing outcomes.</p>

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Virological and Immunological Outcomes of TLD and TLE Regimens as First-Line Therapy in Antiretroviral-Naive Adults: A Retrospective Cohort Study

  • 期刊论文

  • 发表日期：

    2026年2月16日

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  • Biruk T. Mengistie,
  • Kewser S. Yassin,
  • Rahwa A. Kinfe,
  • Ruth S. Belachew,
  • Abel A. Gelan,
  • Caleb M. Hailemariam,
  • Rebecca Haile Tesfay,
  • Chernet T. Mengistie,
  • Mikiyas G. Teferi,
  • Zenebwork Y. Gubai

摘要

Background/Objective

Despite global gains with dolutegravir (DTG), comparative real-world data from sub-Saharan Africa remain valuable. We compared virological, immunological and tolerability outcomes among ART-naïve adults initiating tenofovir/lamivudine/dolutegravir (TLD) versus tenofovir/lamivudine/efavirenz (TLE) at Tikur Anbessa Specialized Hospital, Addis Ababa, Ethiopia.

Methods

We performed a hospital-based retrospective comparative study of adults (≥ 15 years) who started first-line TLD or TLE between 1 August 2022 and 25 February 2024 and had ≥ 6 months follow-up with baseline and follow-up CD4 and/or viral-load data. Primary outcome was viral suppression (HIV-1 RNA < 50 copies/mL) at ~ 24/48 weeks; secondary outcome was change in CD4 count. Multivariable logistic and linear regression adjusted for age, sex, baseline CD4 and adherence.

Results

Among 250 patients (125 TLD, 125 TLE), baseline sociodemographic and clinical characteristics were comparable (mean CD4 308 vs. 311 cells/µL). In bivariate analysis, TLD showed higher odds of viral suppression (COR = 1.78; 95% CI 1.05–3.02; p = 0.033), but after adjustment, there was no statistically significant difference in viral suppression between TLD and TLE (AOR = 1.68; 95% CI 0.91–3.12). Good adherence strongly predicted suppression (AOR = 9.10; 95% CI 3.30–25.10; p < 0.001). Mean CD4 gain was greater with TLD (adjusted B = 40.32 cells/µL; 95% CI 14.76–65.88; p = 0.002). Adverse drug reactions occurred less frequently with TLD (7.2%) than with TLE (17.6%) (χ² = 6.24; p = 0.013).

Conclusion

In this routine-care Ethiopian cohort, TLD and TLE achieved comparable adjusted virological suppression, but TLD produced larger CD4 gains and fewer adverse events. Strengthening adherence support and earlier ART initiation remain central to optimizing outcomes.