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Journal of Medical Microbiology logo Journal of Medical Microbiology

Volume 74, Issue 1

Safety and efficacy of lamivudine/dolutegravir vs. bictegravir/emtricitabine/tenofovir alafenamide in antiretroviral-naive adults with HIV-1 infection in Shanghai, China: a single-centre retrospective study Open Access

Abstract

Lamivudine plus dolutegravir (3TC/DTG) and bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) regimens are commonly used as first-line treatments for people living with human immunodeficiency virus (HIV) (PLWH) worldwide.

There are limited comparative data on the antiviral activity and safety between these regimens in ART-naive PLWH, particularly in China, where the 3TC/DTG regimen was integrated into first-line therapy in 2021 and gained broader adoption after its inclusion in the National Health Insurance in 2022.

This study aims to provide real-world evidence comparing the 3TC/DTG regimen to the B/F/TAF regimen in ART-naive PLWH in China.

This retrospective study enrolled PLWH initiating ART with either 3TC/DTG or B/F/TAF in Shanghai from January 2020 to January 2023. Demographic characteristics and clinical information were collected and compared for each patient.

A total of 380 eligible, ART-naive PLWH were included, with 190 patients in the 3TC/DTG group and 190 patients in the B/F/TAF group. Following the initiation of ART, most patients (94.1 and 89.3% for 3TC/DTG and B/F/TAF groups, respectively) achieved viral suppression (<50 copies of HIV RNA per millilitre) at week 24. The CD4 cell count significantly increased from a baseline of 301.3±185.8 cells per microlitre to 479.5±229.3 cells per microlitre at week 36 for the 3TC/DTG group and from 289.2±188.8 cells per microlitre at baseline to 487.8±234.2 cells per microlitre at week 36 for the B/F/TAF group. Both groups experienced an increase in blood lipid levels after initiating ART, with higher levels of high-density lipoprotein cholesterol (HDL-C) observed in the 3TC/DTG group compared with the B/F/TAF group. Renal and hepatic function indicators remained stable in both groups.

3TC/DTG demonstrates similar antiviral efficacy to B/F/TAF and does not significantly impact liver and kidney functions. Patients receiving 3TC/DTG showed higher plasma HDL-C levels compared with those on B/F/TAF, which confer long-term clinical benefits in reducing cardiovascular risk.

  • Received:
  • Accepted:
  • Published Online:
Keyword(s): antiretroviral therapy , bictegravir , dual therapy , efficacy , HIV-1 and safety
Funding
This study was supported by the:
  • Shanghai Municipal Health Commission (Award shslczdzk01102)
    • Principle Award Recipient: JunyangYang
  • Shanghai Science and Technology Development Foundation (Award 20MC1920100)
    • Principle Award Recipient: JunyangYang
© 2025 The Authors
  • This is an open-access article distributed under the terms of the Creative Commons Attribution License. This article was made open access via a Publish and Read agreement between the Microbiology Society and the corresponding author’s institution.
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2025-01-07
2025-01-13
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References

  1. Cao W, Hsieh E, Li T. Optimizing treatment for adults with HIV/AIDS in China: successes over two decades and remaining challenges. Curr HIV/AIDS Rep 2020; 17:26–34 [View Article] [PubMed]
     [Google Scholar]
  2. Lucas S, Nelson AM. HIV and the spectrum of human disease. J Pathol 2015; 235:229–241 [View Article] [PubMed]
     [Google Scholar]
  3. Biały M, Czarnecki M, Inglot M. Impact of combination antiretroviral treatment on liver metabolic health in HIV-infected persons. Viruses 2023; 15:2432 [View Article] [PubMed]
     [Google Scholar]
  4. Suleman M, Khan SU, Hussain T, Khan MU, Shamsul Hassan S et al. Cardiovascular challenges in the era of antiretroviral therapy for AIDS/ HIV: a comprehensive review of research advancements, pathophysiological insights, and future directions. Curr Probl Cardiol 2024; 49:102353 [View Article] [PubMed]
     [Google Scholar]
  5. Yang J, Chen J, Ji Y, Tang Q, Zhang R et al. Lipid profile and renal safety of tenofovir disoproxil fumarate-based anti-retroviral therapy in HIV-infected Chinese patients. Int J Infect Dis 2019; 83:64–71 [View Article] [PubMed]
     [Google Scholar]
  6. Hui X, Gan X, Li Q, Sun W. Dolutegravir plus lamivudine as initial therapy for HIV-1 infected and ARV-naïve patients in West China, 24-weeks results of a preliminary real-world study. Curr HIV Res 2022; 20:222–227 [View Article] [PubMed]
     [Google Scholar]
  7. Li J, Chen D, Wen Z, Du Y, Huang Z et al. Real-world efficacy and safety of dolutegravir plus lamivudine versus tenofovir plus lamivudine and efavirenz in ART-naïve HIV-1-infected adults. Medicine 2022; 101:e31100 [View Article]
     [Google Scholar]
  8. Wei Y, Li J, Xu R, Wen L, Deng Y et al. Efficacy and safety profiles of dolutegravir plus lamivudine vs . bictegravir/emtricitabine/tenofovir alafenamide in therapy-naïve adults with HIV-1. Chin Med J 2023; 136:2677–2685 [View Article] [PubMed]
     [Google Scholar]
  9. Guidelines for the use of antiretroviral agents in adults and adolescents with HIV; 2024 https://clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-adolescent-arv/whats-new accessed 7 May 2024
  10. EACS guidelines version 12.0; 2023 https://www.eacsociety.org/media/guidelines-12.0.pdf accessed 7 May 2024
  11. Waters L, Winston A, Reeves I, Boffito M, Churchill D et al. BHIVA guidelines on antiretroviral treatment for adults living with HIV-1 2022. HIV Med 2022; 23 Suppl 5:3–115 [View Article] [PubMed]
     [Google Scholar]
  12. Acquired Immunodeficiency Syndrome and Hepatitis C Professional Group SoID, Chinese Medical Association, Chinese Center for Disease Control and Prevention Chinese Guidelines for Diagnosis and Treatment of Human Immunodeficiency Virus Infection/Acquired Immunodeficiency Syndrome (2021 edn) Medical Journal of Peking Union Medical College Hospital; 2021 pp 203–226
     [Google Scholar]
  13. Ma Y-C, Zuo L, Chen J-H, Luo Q, Yu X-Q et al. Modified glomerular filtration rate estimating equation for Chinese patients with chronic kidney disease. J Am Soc Nephrol 2006; 17:2937–2944 [View Article] [PubMed]
     [Google Scholar]
  14. Patel R, Evitt L, Mariolis I, Di Giambenedetto S, d’Arminio Monforte A et al. HIV treatment with the two-drug regimen dolutegravir plus lamivudine in real-world clinical practice: a systematic literature review. Infect Dis Ther 2021; 10:2051–2070 [View Article] [PubMed]
     [Google Scholar]
  15. Radford M, Parks DC, Ferrante S, Punekar Y. Comparative efficacy and safety and dolutegravir and lamivudine in treatment naive HIV patients. AIDS 2019; 33:1739–1749 [View Article] [PubMed]
     [Google Scholar]
  16. Yang X, Fu Y, Xie X, Gan L, Song C et al. Real-world implementation of dolutegravir plus lamivudine in people living with HIV in Southwest China. Expert Rev Anti-infect Ther 2022; 20:1501–1508 [View Article]
     [Google Scholar]
  17. Llibre JM, Brites C, Cheng C-Y, Osiyemi O, Galera C et al. Efficacy and safety of switching to the 2-drug regimen dolutegravir/lamivudine versus continuing a 3- or 4-drug regimen for maintaining virologic suppression in adults living with human immunodeficiency virus 1 (HIV-1): week 48 results from the phase 3, noninferiority SALSA randomized trial. Clin Infect Dis 2023; 76:720–729 [View Article] [PubMed]
     [Google Scholar]
  18. van Wyk J, Ajana F, Bisshop F, De Wit S, Osiyemi O et al. Efficacy and safety of switching to dolutegravir/lamivudine fixed-dose 2-drug regimen vs continuing a tenofovir alafenamide-based 3- or 4-drug regimen for maintenance of virologic suppression in adults living with human immunodeficiency virus type 1: phase 3, randomized, noninferiority TANGO study. Clin Infect Dis 2020; 71:1920–1929 [View Article] [PubMed]
     [Google Scholar]
  19. Crespo-Bermejo C, de Arellano ER, Lara-Aguilar V, Valle-Millares D, Gómez-Lus ML et al. Persistent low-Level viremia in persons living with HIV undertreatment: an unresolved status. Virulence 2021; 12:2919–2931 [View Article] [PubMed]
     [Google Scholar]
  20. Wirden M, Todesco E, Valantin M-A, Lambert-Niclot S, Simon A et al. Low-level HIV-1 viraemia in patients on HAART: risk factors and management in clinical practice. J Antimicrob Chemother 2015; 70:2347–2353 [View Article] [PubMed]
     [Google Scholar]
  21. Gandhi RT, Zheng L, Bosch RJ, Chan ES, Margolis DM et al. The effect of raltegravir intensification on low-level residual viremia in HIV-infected patients on antiretroviral therapy: a randomized controlled trial. PLoS Med 2010; 7:e1000321 [View Article] [PubMed]
     [Google Scholar]
  22. McMahon D, Jones J, Wiegand A, Gange SJ, Kearney M et al. Short-course raltegravir intensification does not reduce persistent low-level viremia in patients with HIV-1 suppression during receipt of combination antiretroviral therapy. Clin Infect Dis 2010; 50:912–919 [View Article] [PubMed]
     [Google Scholar]
  23. Saumoy M, Sanchez-Quesada JL, Ordoñez-Llanos J, Podzamczer D. Do all integrase strand transfer inhibitors have the same lipid profile? Review of randomised controlled trials in naïve and switch scenarios in HIV-infected patients. J Clin Med 2021; 10:3456 [View Article] [PubMed]
     [Google Scholar]
  24. Sax PE, Arribas JR, Orkin C, Lazzarin A, Pozniak A et al. Bictegravir/emtricitabine/tenofovir alafenamide as initial treatment for HIV-1: five-year follow-up from two randomized trials. eClinicalMedicine 2023; 59:101991 [View Article]
     [Google Scholar]
  25. Rohatgi A, Khera A, Berry JD, Givens EG, Ayers CR et al. HDL cholesterol efflux capacity and incident cardiovascular events. N Engl J Med 2014; 371:2383–2393 [View Article] [PubMed]
     [Google Scholar]
  26. Xiang AS, Kingwell BA. Rethinking good cholesterol: a clinicians’ guide to understanding HDL. Lancet Diabet Endocrinol 2019; 7:575–582 [View Article]
     [Google Scholar]
  27. Navab M, Reddy ST, Van Lenten BJ, Fogelman AM. HDL and cardiovascular disease: atherogenic and atheroprotective mechanisms. Nat Rev Cardiol 2011; 8:222–232 [View Article] [PubMed]
     [Google Scholar]
  28. Franczyk B, Rysz J, Ławiński J, Rysz-Górzyńska M, Gluba-Brzózka A. Is a high HDL-cholesterol level always beneficial?. Biomedicines 2021; 9:1083 [View Article] [PubMed]
     [Google Scholar]
  29. Ben-Aicha S, Badimon L, Vilahur G. Advances in HDL: much more than lipid transporters. Int J Mol Sci 2020; 21:732 [View Article] [PubMed]
     [Google Scholar]
  30. Hall AM, Hendry BM, Nitsch D, Connolly JO. Tenofovir-associated kidney toxicity in HIV-infected patients: a review of the evidence. Am J Kidney Dis 2011; 57:773–780 [View Article] [PubMed]
     [Google Scholar]
  31. Lindeman TA, Duggan JM, Sahloff EG. Evaluation of serum creatinine changes with integrase inhibitor use in human immunodeficiency virus-1 infected adults. Open Forum Infect Dis 2016; 3:ofw053 [View Article] [PubMed]
     [Google Scholar]
  32. Mondesert E, Reynes J, Makinson A, Bargnoux A-S, Plawecki M et al. Cystatin C in addition to creatinine for better assessment of glomerular renal function decline in people with HIV receiving antiretroviral therapy. AIDS 2023; 37:447–454 [View Article] [PubMed]
     [Google Scholar]
  33. Hou J, Nast CC. Changing concepts of HIV infection and renal disease. Curr Opin Nephrol Hypertens 2018; 27:144–152 [View Article] [PubMed]
     [Google Scholar]
  34. Bosch B, Akpomiemie G, Chandiwana N, Sokhela S, Hill A et al. Weight and metabolic changes after switching from tenofovir alafenamide/emtricitabine (FTC)+dolutegravir (DTG), tenofovir disoproxil fumarate (TDF)/FTC + DTG, and TDF/FTC/efavirenz to TDF/lamivudine/DTG. Clin Infect Dis 2023; 76:1492–1495 [View Article]
     [Google Scholar]
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Safety and efficacy of lamivudine/dolutegravir vs. bictegravir/emtricitabine/tenofovir alafenamide in antiretroviral-naive adults with HIV-1 infection in Shanghai, China: a single-centre retrospective study
J. Med. Microbiol. 74, 001949 (2025); https://doi.org/10.1099/jmm.0.001949
/content/journal/jmm/10.1099/jmm.0.001949
/content/journal/jmm/10.1099/jmm.0.001949
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