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
. 2023 Jun 1;78(6):1423-1432.
doi: 10.1093/jac/dkad102.

Effectiveness and tolerability of dolutegravir/lamivudine for the treatment of HIV-1 infection in clinical practice

Inés Suárez-García  1   2   3 , Belén Alejos  4 , Victoria Hernando  2   5 , Laura Viñuela  6   7 , Mar Vera García  8 , David Rial-Crestelo  2   9 , María Jesús Pérez Elías  2   10 , Helena Albendín Iglesias  11   12 , Joaquim Peraire  2   13   14 , Juan Tiraboschi  15 , Asunción Díaz  2   5 , Santiago Moreno  2   10 , Inma Jarrín  2   16 ; Cohort of the Spanish HIV/AIDS Research Network (CoRIS)
Collaborators, Affiliations

Effectiveness and tolerability of dolutegravir/lamivudine for the treatment of HIV-1 infection in clinical practice

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

Abstract

Objectives: To assess the effectiveness and tolerability of dolutegravir (DTG)/lamivudine (3TC) among treatment-naive and virologically suppressed treatment-experienced individuals in the multicentre cohort of the Spanish HIV/AIDS Research Network (CoRIS) during the years 2018-2021.

Methods: We used multivariable regression models to compare viral suppression (VS) [HIV RNA viral load (VL) <50 copies/mL] and the change in CD4 cell counts at 24 and 48 (±12) weeks after initiation with dolutegravir/lamivudine or other first-line ART regimens.

Results: We included 2160 treatment-naive subjects, among whom 401 (18.6%) started with dolutegravir/lamivudine. The remaining subjects started bictegravir (BIC)/emtricitabine (FTC)/tenofovir alafenamide (TAF) (n = 949, 43.9%), DTG + FTC/tenofovir disoproxil fumarate (TDF) (n = 282, 13.1%), DTG/3TC/abacavir (ABC) (n = 255, 11.8%), darunavir (DRV)/cobicistat(COBI)/FTC/TAF (n = 147, 6.8%) and elvitegravir (EVG)/COBI/FTC/TAF (n = 126, 5.8%). At 24 and 48 weeks after starting dolutegravir/lamivudine, 91.4% and 93.8% of the subjects, respectively, achieved VS. The probability of achieving VS with dolutegravir/lamivudine was not significantly different compared with any other regimen at 24 or 48 weeks, with the exception of a lower chance of achieving VS at 24 weeks for DRV/COBI/FTC/TAF (adjusted OR: 0.47; 95% CI: 0.30-0.74) compared with dolutegravir/lamivudine.For the analysis of treatment-experienced virally suppressed subjects we included 1456 individuals who switched to dolutegravir/lamivudine, among whom 97.4% and 95.5% maintained VS at 24 and 48 weeks, respectively. During the first 48 weeks after dolutegravir/lamivudine initiation, 1.0% of treatment-naive and 1.5% of treatment-experienced subjects discontinued dolutegravir/lamivudine due to an adverse event.

Conclusions: In this large multicentre cohort, effectiveness and tolerability of dolutegravir/lamivudine were high among treatment-naive and treatment-experienced subjects.

PubMed Disclaimer

Figures

Figure 1.
Figure 1.
First-line antiretroviral regimens prescribed in antiretroviral-naive individuals from the CoRIS cohort, 2018–2021. DTG + FTC/TDF, dolutegravir + emtricitabine/tenofovir disoproxil fumarate; EVG/COBI/FTC/TAF, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide; DRV/COBI/FTC/TAF, darunavir/cobicistat/emtricitabine/tenofovir alafenamide; DTG/3TC/ABC, dolutegravir/lamivudine/abacavir; BIC/FTC/TAF, bictegravir/emtricitabine/tenofovir alafenamide; DTG/3TC, dolutegravir/lamivudine.
Figure 2.
Figure 2.
Sociodemographic and clinical characteristics of individuals at ART initiation according to first-line antiretroviral regimen, CoRIS cohort, 2018–2021. p-value ** 0.046 0.041 0.007 0.002 <0.001 <0.001p-value * 0.018 0.040 <0.001 0.455 <0.001 <0.001 P values* for the comparison between DTG/3TC vs 3DR-InSTI (three-drug regimen including integrase inhibitor: BIC/FTC/TAF, DTG/3TC/ABC, EVG/COBI/FTC/TAF and DTG + FTC/TDF). P values** for the global comparison according to initial regimen. DTG/3TC, dolutegravir/lamivudine; 3DR-InSTI, three-drug regimen including integrase inhibitor (BIC/FTC/TAF, DTG/3TC/ABC, EVG/COBI/FTC/TAF and DTG + FTC/TDF); BIC/FTC/TAF, bictegravir/emtricitabine/tenofovir alafenamide; DTG/3TC/ABC, dolutegravir/lamivudine/abacavir; DRV/COBI/FTC/TAF, darunavir/cobicistat/emtricitabine/tenofovir alafenamide; EVG/COBI/FTC/TAF, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide; DTG + FTC/TDF, dolutegravir + emtricitabine/tenofovir disoproxil fumarate.
Figure 3.
Figure 3.
Adjusted comparison of viral suppression and change in CD4 cell counts at 24 and 48 weeks from ART initiation by first-line antiretroviral regimen, ITT analyses, CoRIS cohort, 2018–2021. Adjusted for sex, age at ART initiation, transmission category, educational level, country of origin, CD4 cell count and viral load within the 6 months previous to ART initiation, presence of hepatitis C virus antibodies, presence of hepatitis B virus surface antigen, and AIDS diagnosis at initiation of ART. Note: Subjects were not randomized to these treatments because they were prescribed in routine clinical practice. DTG/3TC, dolutegravir/lamivudine; 3DR-InSTI, three-drug regimen including integrase inhibitor (BIC/FTC/TAF, DTG/3TC/ABC, EVG/COBI/FTC/TAF and DTG + FTC/TDF); BIC/FTC/TAF, bictegravir/emtricitabine/tenofovir alafenamide; DTG/3TC/ABC, dolutegravir/lamivudine/abacavir; DRV/COBI/FTC/TAF, darunavir/cobicistat/emtricitabine/tenofovir alafenamide; EVG/COBI/FTC/TAF, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide; DTG + FTC/TDF, dolutegravir + emtricitabine/tenofovir disoproxil fumarate.
See this image and copyright information in PMC

References

    1. Cahn P, Madero JS, Arribas JRet 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 Tet 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. Llibre JM, Brites C, Cheng CYet 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 HIV-1: week 48 results from the phase 3, non-inferiority SALSA randomized trial. Clin Infect Dis 2022; 76: 720–9. 10.1093/cid/ciac130 - DOI - PMC - PubMed
    1. van Wyk J, Ajana F, Bisshop Fet 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: 1920–9. 10.1093/cid/ciz1243 - DOI - PMC - PubMed
    1. Kennedy-Martin T, Curtis S, Faries Det al. . A literature review on the representativeness of randomized controlled trial samples and implications for the external validity of trial results. Trials 2015; 16: 495. 10.1186/s13063-015-1023-4 - DOI - PMC - PubMed

Publication types

MeSH terms