Evidence mapPaperPMID 40577173Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2026

A Randomized Trial to Compare Dolutegravir Plus Boosted Darunavir Versus Recommended Standard of Care Antiretroviral Regimens in People With HIV-1, Whose First-line Non-nucleoside Reverse Transcriptase Inhibitor Therapy Has Failed: Final 96-week Results of the D2EFT Study.

Phyo Pyae Nyein, Margaret Borok, Nnakelu Eriobu, Richard Kaplan, Nagalingeswaran Kumarasamy, Anchalee Avihingsanon, Marcelo H Losso, Iskandar Azwa, Muhammad Karyana, Sounkalo Dao and 17 more

Abstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase III
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Tenofovir, Interferon Pathways, and Mucosal Immunity: Implications for People Living With HIV.American journal of reproductive immunology (New York, N.Y. : 1989) · 2026
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

27 authors.

Phyo Pyae NyeinThe Kirby Institute, University of New South Wales, Sydney, Australia.ORCID 0009-0001-6470-8548
Margaret BorokDepartment of Internal Medicine, Faculty of Medicine and Health Sciences, University of Zimbabwe Clinical Research Centre, Harare, Zimbabwe.
Nnakelu EriobuInternational Research Center of Excellence (IRCE), Institute of Human Virology Nigeria, Abuja, Nigeria.
Richard KaplanDesmond Tutu Health Foundation, Cape Town, South Africa.
Nagalingeswaran KumarasamyChennai Antiviral Research and Treatment Clinical Research Site (CART CRS) Voluntary Health Services (VHS), Chennai, India.
Anchalee AvihingsanonHIV-NAT, Thai Red Cross AIDS and Infectious Disease Research Centre, and Center of Excellence in Tuberculosis, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.ORCID 0000-0003-3222-9611
Marcelo H LossoCICAL, Fundación IBIS, Buenos Aires, Argentina.
Iskandar AzwaInfectious Disease Unit, Department of Medicine and Centre of Excellence for Research in Infectious Diseases & AIDS (CERIA), Faculty of Medicine, Universiti Malaya, Kuala Lumpur, Malaysia.
Muhammad KaryanaINA-RESPOND, Jakarta, Indonesia.
Sounkalo DaoDepartment of Infectious and Tropical Diseases, Faculty of Medicine and Dentistry, University of Science, Technics and Technologies of Bamako, Mali.
Mohamed CisseCentre de traitement ambulatoire de Donka (Hospital de jour), Université Gamal Abdel Nasser de Conakry, Conakry, Guinea.ORCID 0000-0002-6859-8745
Jaime F Andrade VillanuevaHospital Civil de Guadalajara "Fray Antonio Alcalde", Guadalajara, Mexico.ORCID 0000-0003-1948-655X
Sergio LupoInstituto CAICI (Instituto Centralizado de Asistencia e Investigación Clinica Integral), Rosario, Argentina.
Sandra Wagner CardosoFiocruz-Instituto Nacional de Infectologia (INI), Rio de Janeiro, Brazil.
Evy YunihastutiCipto Mangunkusumo Hospital/Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia.ORCID 0000-0001-6650-0559
Yanri Wijayanti SubrontoDepartment of Internal Medicine/Centre of Tropical Medicine Study Program, Faculty of Medicine, Public Health, and Nursing Universitas Gadjah Mada/Dr. Sardjito General Hospital, Yogyakarta, Indonesia.
Munawaroh FitriahDepartment of Clinical Pathology, Faculty of Medicine, Universitas Airlangga/Dr. Soetomo General Academic Hospital, Surabaya, Indonesia.
Sudirman KatuDepartment of Internal Medicine, Faculty of Medicine, Universitas Hasanuddin/Division of Tropical and Infection Disease, Dr. Wahidin Sudirohusodo Hospital, Makassar, South Sulawesi, Indonesia.
Dannae BrownGlobal Medical Sciences, ViiV Healthcare, Abbotsford, New South Wales, Australia.
Emmanuelle PapotThe Kirby Institute, University of New South Wales, Sydney, Australia.
Jolie HutchinsonThe Kirby Institute, University of New South Wales, Sydney, Australia.
Anthony KelleherThe Kirby Institute, University of New South Wales, Sydney, Australia.
Josh HansonThe Kirby Institute, University of New South Wales, Sydney, Australia.ORCID 0000-0002-1423-3839
Nila J DharanThe Kirby Institute, University of New South Wales, Sydney, Australia.
Kathy PetoumenosThe Kirby Institute, University of New South Wales, Sydney, Australia.
Gail V MatthewsThe Kirby Institute, University of New South Wales, Sydney, Australia.ORCID 0000-0002-1048-6396
D2EFT Study Team

Funding

Janssen PharmaceuticaNational Health and Medical Research Council, Australia APP1104610National Institute of Allergy and Infectious DiseasesNIH HHS 18Q065NIH HHS 19Q120UNITAID 2016-09-UNSWViiV Healthcare
6 · The paper itself

Abstract

backgroundLonger-term outcome data following second-line antiretroviral therapy initiation in resource-limited settings is limited, especially in regions where genotypic resistance is inaccessible. This analysis evaluated extended efficacy and tolerability data from the D2EFT study.

methodsD2EFT is a completed, multicenter, phase IIIB/IV, randomized, open-label trial in 14 low- and middle-income countries. People with human immunodeficiency virus (HIV) who had failed first-line non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimens were switched to 1 of ritonavir-boosted darunavir plus 2 nucleoside reverse transcriptase inhibitors (DRV/r + 2NRTIs), ritonavir-boosted darunavir plus dolutegravir (DTG + DRV/r), or dolutegravir with tenofovir disoproxil fumarate plus either lamivudine or emtricitabine (DTG + TDF/XTC), with or without pre-switch genotyping. Here we report virological suppression at 96 weeks, defined as HIV RNA <50 copies/mL in a modified intention-to-treat population.

resultsBetween November 2017 and January 2022, 1190 participants were screened, 828 were randomized, and 826 were included in the analysis. At week 96, the proportions of participants with HIV RNA <50 copies/mL were 191/251 (76.1%) in DRV/r + 2NRTIs, 215/251 (85.7%) in DTG + DRV/r, and 231/283 (81.6%) in DTG + TDF/XTC. The treatment differences (95% confidence intervals [CIs]) in proportions achieving virological suppression were 9.6% (2.7, 16.4) in DTG + DRV/r and 9.0% (1.4, 16.6) in DTG + TDF/XTC, compared to DRV/r + 2NRTIs. Intermediate or high-level dolutegravir resistance was identified in 3/27 (13%) of virological failures in individuals taking DTG + TDF/XTC but in no one taking DTG + DRV/r. No darunavir resistance was observed.

conclusionsAfter 96 weeks of follow-up, DTG + DRV/r and DTG + TDF/XTC demonstrated virological superiority over DRV/r + 2NRTIs after first-line NNRTI-failure. However, emerging dolutegravir resistance, which was observed only in individuals taking DTG + TDF/XTC, requires ongoing global surveillance.

Indexed as

Anti-HIV AgentsDarunavirHeterocyclic Compounds, 3-RingHIV-1HIV InfectionsAdultAntiretroviral Therapy, Highly ActiveDrug Therapy, CombinationFemaleHumansMaleMiddle AgedOxazinesPiperazinesPyridonesReverse Transcriptase InhibitorsAnti-HIV AgentsDarunavirHeterocyclic Compounds, 3-RingOxazinesPiperazinesPyridonesReverse Transcriptase Inhibitorsantiretroviral therapydeveloping countriesdolutegravirRCTsecond-line

Identifiers

PMID40577173
PMCPMC13375576

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.