Abstract
Background
Confirming the efficacy of dolutegravir/lamivudine in clinical practice solidifies recommendations on its use.
Methods
Prospective cohort study (DUALING) in 24 human immunodeficiency virus (HIV) treatment centers in the Netherlands. HIV RNA–suppressed cases were on triple-drug antiretroviral regimens without prior virological failure or resistance and started dolutegravir/lamivudine. Cases were 1:2 matched to controls on triple-drug antiretroviral regimens by the use of dolutegravir-based regimens, age, sex, transmission route, CD4+ T-cell nadir, and HIV RNA zenith. The primary endpoint was the treatment failure rate in cases versus controls at 1 year by intention-to-treat and on-treatment analyses with 5% noninferiority margin.
Results
The 2040 participants were 680 cases and 1380 controls. Treatment failure in the 390 dolutegravir-based cases versus controls occurred in 8.72% and 12.50% (difference: −3.78% [95% confidence interval {CI}, −7.49% to .08%]) by intention-to-treat and 1.39% and 0.80% (difference: 0.59% [95% CI, –.80% to 1.98%]) by on-treatment analyses. The treatment failure risk in 290 non-dolutegravir-based cases was also noninferior to controls. Antiretroviral regimen modifications unrelated to virological failure explained the higher treatment failure rate by intention-to-treat. A shorter time on triple-drug antiretroviral therapy and being of non-Western origin was associated with treatment failure. Treatment failure, defined as 2 consecutive HIV RNA >50 copies/mL, occurred in 4 cases and 5 controls but without genotypic resistance detected. Viral blips occured comparable in cases and controls but cases gained more weight, especially when tenofovir-based regimens were discontinued.
Conclusions
In routine care, dolutegravir/lamivudine was noninferior to continuing triple-drug antiretroviral regimens after 1 year, supporting the use of dolutegravir/lamivudine in clinical practice.
Clinical Trials Registration
NCT04707326.
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Details
1 Section of Infectious Diseases, Department of Internal Medicine, and Department of Medical Microbiology and Infectious Diseases, Erasmus University Medical Center , Rotterdam , The Netherlands
2 Stichting HIV Monitoring , Amsterdam , The Netherlands
3 Department of Internal Medicine, Spaarne Gasthuis , Haarlem/Hoofddorp , The Netherlands
4 Department of Internal Medicine, Medisch Spectrum Twente , Enschede , The Netherlands
5 Department of Internal Medicine, Catharina Ziekenhuis Eindhoven , Eindhoven , The Netherlands
6 Department of Internal Medicine, Elisabeth Tweesteden Ziekenhuis , Tilburg , The Netherlands
7 Department of Internal Medicine, Haaglanden Medisch Centrum , The Hague , The Netherlands
8 Department of Internal Medicine, Rijnstate Ziekenhuis , Arnhem , The Netherlands
9 Department of Internal Medicine, Maasstadziekenhuis , Rotterdam , The Netherlands
10 Department of Internal Medicine, Admiraal de Ruyter Ziekenhuis , Vlissingen , The Netherlands
11 Department of Infectious Diseases, Leiden University Medical Center , Leiden , The Netherlands
12 Section of Infectious Diseases, Department of Internal Medicine, University of Groningen, University Medical Center Groningen , Groningen , The Netherlands
13 Department of Internal Medicine, Isala , Zwolle , The Netherlands
14 Infectious Diseases and Infection Prevention, Department of Internal Medicine and Department of Medical Microbiology, Maastricht University Medical Center , Maastricht , The Netherlands
15 Department of Internal Medicine, University Medical Center Utrecht , Utrecht , The Netherlands
16 Section of Infectious Diseases, Department of Internal Medicine, Radboud University Medical Center , Nijmegen , The Netherlands
17 Amsterdam Infection and Immunity Institute, Department of Infectious Diseases, Amsterdam University Medical Centers, University of Amsterdam , Amsterdam , The Netherlands
18 Department of Internal Medicine, Onze Lieve Vrouwe Gasthuis , Amsterdam , The Netherlands