Evidence map›Paper›PMID 31905383›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2020

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.

Jean van Wyk, Faïza Ajana, Fiona Bisshop, Stéphane De Wit, Olayemi Osiyemi, Joaquín Portilla Sogorb, Jean-Pierre Routy, Christoph Wyen, Mounir Ait-Khaled, Maria Claudia Nascimento and 8 more

5 registry-linked trialsOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled TrialEquivalence Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 132 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
132citing papers in PubMed, 6 pooled it
4.3field-weighted citation impact, top 4% of its field
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.

NCT03446573 phase3completednot on this map

A Phase III, Randomized, Multicenter, Parallel-group, Non-inferiority Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Dolutegravir Plus Lamivudine in HIV-1 Infected Adults Who Are Virologically Suppressed

TypeinterventionalSponsorViiV HealthcareRan2018 to 2022Enrolled743ConditionsHIV InfectionsArmsDTG + 3TC, TAF based regimen (TBR)
NCT04638686 completednot on this map

Efficacy and Safety of Dolutegravir + Lamivudine in Antiretroviral Treatment-naive Adults With HIV-1 Infection in a Multicenter Real-life Cohort Study

TypeobservationalSponsorInstituto de Investigación Sanitaria de la Fundación Jiménez DíazRan2020 to 2022Enrolled185ConditionsHIV-1-infectionArmsDolutegravir 50 MG, Lamivudine 300 MG
NCT04867083 phase3unknown statusnot on this mapstarted 2021, after this paper: background citation

Randomized, Open-label and Multicentric Trial Evaluating the Non-inferiority of Antiretroviral Dual Therapy Taken 4 Consecutive Days Per Week Versus Antiretroviral Dual Therapy 7/7 Days Per Week in HIV-1 Infected Patients With Controlled Viral Load Under Antiretroviral Dual Therapy

TypeinterventionalSponsorANRS, Emerging Infectious DiseasesRan2021 to 2024Enrolled440ConditionsHIV InfectionsArmsARV bitherapie
NCT06393387 completednot on this mapstarted 2024, after this paper: background citation

Retrospective Review of DTG/3TC Versus BIC/F/TAF Across a Multi Clinic Infectious Disease Organization in Southeast United States (REVIVE Study)

TypeobservationalSponsorMidway Specialty Care CenterRan2024 to 2025Enrolled800ConditionsHiv, HIV-1-infection, HIV InfectionsArmsDTG/3TC versus BIC/F/TAF
NCT07138144 phase4recruitingnot on this mapstarted 2025, after this paper: background citation

Efficacy, Safety, and Tolerability of Switching to a Two-Drug Regimen With DTG/3TC Compared to Maintaining a Three-Drug Regimen With BIC/FTC/TAF or DTG/3TC/ABC in Virologically Suppressed PeopLe Living With HIV After 24 and 48 Weeks of Follow-Up

TypeinterventionalSponsorJosé Antonio Mata MarínRan2025 to 2026Enrolled156ConditionsHIV InfectionsArmsStandard Medical Therapy, dual therapy
3 · Its place in the literature

Who cites it

132 citing papers in PubMed, 6 syntheses or guidelines pooled it, 261 citations in OpenAlex.

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72 more citing papers are in PubMed but not listed here.

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

18 authors at 9 institutions in 8 countries.

Jean van WykViiV Healthcare, Brentford, United Kingdom.
Faïza AjanaCentre Hospitalier de Tourcoing, Tourcoing, France.
Fiona BisshopHoldsworth House Medical Brisbane, Queensland, Australia.
Stéphane De WitCHU Saint-Pierre, Université Libre de Bruxelles, Brussels, Belgium.
Olayemi OsiyemiTriple O Research Institute PA, West Palm Beach, Florida, USA.
Joaquín Portilla SogorbHospital General Universitario de Alicante, Alicante, Spain.
Jean-Pierre RoutyMcGill University Health Centre, Montreal, Quebec, Canada.
Christoph WyenPraxis am Ebertplatz, Cologne, Germany.
Mounir Ait-KhaledViiV Healthcare, Brentford, United Kingdom.
Maria Claudia NascimentoViiV Healthcare, Brentford, United Kingdom.
Keith A PappaViiV Healthcare, Research Triangle Park, North Carolina, USA.
Ruolan WangViiV Healthcare, Research Triangle Park, North Carolina, USA.
Jonathan WrightGlaxoSmithKline, Stockley Park, United Kingdom.
Allan R TenorioViiV Healthcare, Research Triangle Park, North Carolina, USA.
Brian WynneViiV Healthcare, Research Triangle Park, North Carolina, USA.
Michael AboudViiV Healthcare, Brentford, United Kingdom.
Martin J GartlandViiV Healthcare, Research Triangle Park, North Carolina, USA.
Kimberly Y SmithViiV Healthcare, Research Triangle Park, North Carolina, USA.
ViiV Healthcare (United Kingdom) · GBCentre Hospitalier de Tourcoing · FRFriedrich-Ebert-Stiftung e.V. · DEGlaxoSmithKline (United Kingdom) · GBHospital General Universitario de Alicante Doctor Balmis · ESMcGill University Health Centre · CATriple O Medical Services · USUniversité Libre de Bruxelles · BEWesley Research Institute · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe 2-drug regimen dolutegravir (DTG) + lamivudine (3TC) is indicated for treatment-naive adults with human immunodeficiency virus type 1 (HIV-1). We present efficacy and safety of switching to DTG/3TC in virologically suppressed individuals.

methodsTANGO is an open-label, multicenter, phase 3 study that randomized adults (1:1, stratified by baseline third agent class) with HIV-1 RNA <50 copies/mL to switch to once-daily fixed-dose DTG/3TC or remain on a tenofovir alafenamide (TAF)-based regimen. The primary end point was proportion of participants with HIV-1 RNA ≥50 copies/mL at week 48 (US Food and Drug Administration Snapshot algorithm) in the intention-to-treat-exposed population (4% noninferiority margin).

results743 adults were enrolled; 741 received ≥1 dose of study drug (DTG/3TC, N = 369; TAF-based regimen, N = 372). At week 48, proportion of participants with HIV-1 RNA ≥50 copies/mL receiving DTG/3TC was 0.3% (1/369) vs 0.5% (2/372) with a TAF-based regimen (adjusted treatment difference [95% confidence interval], -0.3 [-1.2 to .7]), meeting noninferiority criteria. No participants receiving DTG/3TC and 1 receiving a TAF-based regimen met confirmed virologic withdrawal criteria, with no emergent resistance at failure. Drug-related grade ≥2 adverse events and withdrawals due to adverse events occurred in 17 (4.6%) and 13 (3.5%) participants with DTG/3TC and 3 (0.8%) and 2 (0.5%) with a TAF-based regimen, respectively.

conclusionsDTG/3TC was noninferior in maintaining virologic suppression vs a TAF-based regimen at week 48, with no virologic failure or emergent resistance reported with DTG/3TC, supporting it as a simplification strategy for virologically suppressed people with HIV-1. CLINICAL TRIALS REGISTRATION: NCT03446573.

Indexed as

Anti-HIV AgentsHIV-1HIV InfectionsPharmaceutical PreparationsAdenineAdultAlanineDolutegravirHeterocyclic Compounds, 3-RingHumansLamivudineOxazinesPiperazinesPyridonesTenofovirTreatment OutcomeAdenineAlanineAnti-HIV AgentsDolutegravirHeterocyclic Compounds, 3-RingLamivudineOxazinesPharmaceutical PreparationsPiperazinesPyridonesTenofovirtenofovir alafenamide2-drug regimenintegrase strand transfer inhibitornucleoside reverse transcriptase inhibitorsimplificationvirologic suppression

Identifiers

PMID31905383
PMCPMC7643745
OpenAlexW3000709627

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

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 OpenQuestion graph.