ArticleOpen forum infectious diseases2020
Efficacy and Safety of Switching to Dolutegravir With Boosted Darunavir in Virologically Suppressed Adults With HIV-1: A Randomized, Open-Label, Multicenter, Phase 3, Noninferiority Trial: The DUALIS Study.
Article in Open forum infectious diseases, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.
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Who cites it
17 citing papers in PubMed, 30 citations in OpenAlex.
- Efficacy and Safety of Dolutegravir Plus Emtricitabine vs Combined Antiretroviral Therapy for the Maintenance of HIV Suppression: Results Through Week 144 of the SIMPL'HIV Trial.Open forum infectious diseases · 2024Trial
- Virologic outcomes of switching to boosted darunavir plus dolutegravir with respect to history of drug resistance.AIDS research and therapy · 2021Trial
- Real-world clinical and laboratory changes after switching to two-drug regimen in HIV-suppressed individuals: 48 weeks and beyond.HIV medicine · 2026Article
- Occult hepatitis B and risk of reactivation following switch to non-hepatitis B virus-active antiretroviral therapy in people with HIV.AIDS (London, England) · 2026Review
- Tenofovir, Interferon Pathways, and Mucosal Immunity: Implications for People Living With HIV.American journal of reproductive immunology (New York, N.Y. : 1989) · 2026Review
- Risk of clinical events in virologically suppressed people with HIV switching to a two-drug regimen vs. remaining on a three-drug regimen: a target trial emulation.EClinicalMedicine · 2025Article
- Safe Switch to an Oral Two-Drug Regimen Based on Dolutegravir in People With Vertically Acquired HIV-1: An Observational Multicenter Study.Health science reports · 2025Article
- Health Economics Evaluation of Bictegravir/Emtricitabine/Tenofovir for a First-Line Treatment of HIV-1 Infection in China.ClinicoEconomics and outcomes research : CEOR · 2025Article
- Prevalence of Emergent Dolutegravir Resistance Mutations in People Living with HIV: A Rapid Scoping Review.Viruses · 2024Article
- Simultaneous pharmacokinetic modeling of unbound and total darunavir with ritonavir in adolescents: a substudy of the SMILE trial.Antimicrobial agents and chemotherapy · 2024Article
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- Article
- Two-drug regimens for HIV treatment.The lancet. HIV · 2022Review
- Real-world effectiveness and durability of dual antiretroviral therapy in HIV-infected patients.European journal of hospital pharmacy : science and practice · 2022Article
- Antiretroviral Refill Histories as a Predictor of Future Human Immunodeficiency Virus Viremia.Open forum infectious diseases · 2022Article
- Reply: Beyond Viral Suppression.Open forum infectious diseases · 2021Article
- Beyond Viral Suppression.Open forum infectious diseases · 2021Article
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Authors and funding
22 authors at 10 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDolutegravir (DTG) and boosted darunavir (bDRV) are potent antiretrovirals with a high resistance barrier and might be valuable switch options for people with HIV (PWH).
methodsDUALIS, a randomized, open-label, phase 3b, noninferiority clinical trial, compared the switch to DTG + bDRV (2DR) with continuation of 2 nucleoside reverse transcriptase inhibitors (2NRTI) + bDRV (3DR). PWH with HIV RNA <50 copies/mL taking 2NRTI + bDRV (3DR) for ≥24 weeks (1 accepted blip <200 copies/mL) were randomized to either switch to DTG 50 mg + DRV 800 mg (boosted with 100 mg of ritonavir) or continue taking 3DR. The primary end point (PE) was the proportion of HIV RNA <50 copies/mL at week (W) 48. Change in NRTI backbone was not classified as failure. The estimated sample size for PE analysis was 292; the noninferiority margin was ≤-10.0%.
resultsIn total, 263 subjects were randomized and treated (2DR n = 131, 3DR n = 132; 90.1% male; 89.7% Caucasian; median age [interquartile range], 48 [39-54] years). At W48, 86.3% (n = 113/131) of the 2DR subject and 87.9% (n = 116/132) of the 3DR subjects had HIV RNA <50 copies/mL; the difference between arms was -1.6% (95.48% CI, based on the adjusted alpha level accounting for the interim analysis at W24, -9.9% to +6.7%; discontinuations due to adverse events: 2DR, 4.6% [n = 6]; 3DR, 0.8% [n = 1]). Kaplan-Meier estimates of confirmed HIV RNA ≥50 copies/mL at W48 were 1.6% (n = 2) in the 2DR and 3.1% (n = 4) in the 3DR group. Development of treatment-emergent resistance was not observed.
conclusionsSwitching to DTG + bDRV was noninferior to continuing 3DR in subjects already treated with bDRV.
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