Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Multicenter Study
. 2025 Mar 3;80(3):682-691.
doi: 10.1093/jac/dkae456.

Long-term effectiveness and tolerability of dolutegravir/lamivudine in treatment-naive people with HIV: an analysis of a multicentre cohort at 96 weeks

Collaborators, Affiliations
Multicenter Study

Long-term effectiveness and tolerability of dolutegravir/lamivudine in treatment-naive people with HIV: an analysis of a multicentre cohort at 96 weeks

Inés Suárez-García et al. J Antimicrob Chemother. .

Abstract

Objectives: To evaluate the long-term effectiveness, persistence and tolerability of dolutegravir (DTG)/lamivudine (3TC), compared with the most frequently prescribed first-line treatment regimens, among antiretroviral-naive people with HIV from CoRIS, a multicentre cohort in Spain, in 2018-23.

Methods: We used multivariable regression models to compare viral suppression (VS) (HIV RNA viral load <50 copies/mL), change in CD4 cell counts, persistence and treatment discontinuations due to adverse events (AEs), at 96 (±24) weeks after treatment initiation.

Results: Of 2359 participants, DTG/3TC was prescribed in 472 (20.0%), bictegravir/tenofovir alafenamide (TAF)/emtricitabine (FTC) in 1134 (48.1%), DTG + tenofovir disoproxil fumarate/FTC in 300 (12.7%), DTG/abacavir/3TC in 273 (11.6%) and darunavir/cobicistat/TAF/FTC in 180 (7.6%). At 96 weeks from treatment initiation, 94.0% of participants initiating with DTG/3TC achieved VS, and the mean increase in CD4 cell counts was 295.5 cells/μL (95% CI: 269.9-321.1). During the first 96 weeks after DTG/3TC initiation, 9.8% and 1.3% discontinued their initial regimen, overall and due to AEs, respectively. In multivariable analyses, we did not find significant differences in VS or increase in CD4 cell counts among participants initiating with DTG/3TC compared with other regimens. Initiating ART with a regimen other than DTG/3TC was associated with a higher risk of treatment discontinuation, overall and due to AEs.

Conclusions: Among treatment-naive people with HIV from this large multicentre cohort, DTG/3TC had similar effectiveness and better persistence and tolerability than those of the most frequently prescribed first-line regimens at 96 weeks.

PubMed Disclaimer

Figures

Figure 1.
Figure 1.
Cumulative incidence curve of treatment discontinuation during the first 96 weeks after ART initiation according to first-line antiretroviral regimen, CoRIS cohort, 2018–23. sHR, sub-distribution hazard ratio. *Adjusted for sex, age at ART initiation, transmission category, educational level, country of origin, CD4 cell count and VL within 6 months previous to ART initiation, presence of HCV antibodies, presence of HBV surface antigen and previous AIDS diagnosis at ART initiation.

References

    1. Cahn P, Madero JS, Arribas JR et al. Dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naive adults with HIV-1 infection (GEMINI-1 and GEMINI-2): week 48 results from two multicentre, double-blind, randomised, non-inferiority, phase 3 trials. Lancet 2019; 393: 143–55. 10.1016/S0140-6736(18)32462-0. - DOI - PubMed
    1. Rolle CP, Berhe M, Singh T et al. Dolutegravir/lamivudine as a first-line regimen in a test-and-treat setting for newly diagnosed people living with HIV. AIDS 2021; 35: 1957–65. 10.1097/QAD.0000000000002979 - DOI - PMC - PubMed
    1. European AIDS Clinical Society . EACS guidelines version 12.0. October 2023. 2023. https://www.eacsociety.org/media/guidelines-12.0.pdf.
    1. Panel on Antiretroviral Guidelines for Adults and Adolescents. Department of Health and Human Sciences . Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV. 2024. https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/ad....
    1. División Panel de expertos de GeSIDA y División de control de VIH I, Hepatitis virales y, Tuberculosis. Plan Nacional sobre el SIDA . Documento de consenso de GeSIDA/Plan Nacional sobre el Sida respecto al tratamiento antirretroviral en adultos infectados por el virus de la inmunodeficiencia humana (Actualización enero 2022). 2022. https://gesida-seimc.org/wp-content/uploads/2023/01/GuiaGeSIDAPlanNacion....

Publication types

MeSH terms