Evidence map›Paper›PMID 35079789›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2022

Efficacy and Safety of Switching to Dolutegravir/Lamivudine Versus Continuing a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With Human Immunodeficiency Virus Type 1: Results Through Week 144 From the Phase 3, Noninferiority TANGO Randomized Trial.

Olayemi Osiyemi, Stéphane De Wit, Faïza Ajana, Fiona Bisshop, Joaquín Portilla, Jean Pierre Routy, Christoph Wyen, Mounir Ait-Khaled, Peter Leone, Keith A Pappa and 7 more

Registry-linked trialOpen access · hybridAbstract readRandomized 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, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07678268 (Effectiveness and Safety of Darunavir/Cobicistat Plus Lamivudine Compared With Darunavir/Cobicistat Plus Tenofovir Alafenamide/Emtricitabine in Virologically Suppressed People Living With HIV at 24 and 48 Weeks of Follow-up), which is not on this map. Cited by 75 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
75citing papers in PubMed, 4 pooled it
12.1field-weighted citation impact, top 1% 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.

NCT07678268 phase4recruitingnot on this mapstarted 2025, after this paper: background citation

Effectiveness and Safety of Darunavir/Cobicistat Plus Lamivudine Compared With Darunavir/Cobicistat Plus Tenofovir Alafenamide/Emtricitabine in Virologically Suppressed People Living With HIV at 24 and 48 Weeks of Follow-up

TypeinterventionalSponsorInstituto Mexicano del Seguro SocialRan2025 to 2026Enrolled78ConditionsHIV Infection, Antiretroviral Therapy, Lentivirus InfectionsArmsDual therapy: darunavir/cobicistat + lamivudine, Triple therapy: darunavir/cobicistat plus tenofovir alafenamide/emtricitabine
3 · Its place in the literature

Who cites it

75 citing papers in PubMed, 4 syntheses or guidelines pooled it, 128 citations in OpenAlex.

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15 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

17 authors at 10 institutions in 9 countries.

Olayemi OsiyemiTriple O Research Institute PA, West Palm Beach, Florida, USA.
Stéphane De WitCHU Saint-Pierre, Université Libre de Bruxelles, Brussels, Belgium.
Faïza AjanaCentre Hospitalier de Tourcoing, Tourcoing, France.
Fiona BisshopHoldsworth House Medical Brisbane, Queensland, Australia.
Joaquín PortillaHospital 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.
Peter LeoneViiV Healthcare, Research Triangle Park, North Carolina, USA.
Keith A PappaViiV Healthcare, Research Triangle Park, North Carolina, USA.
Ruolan WangViiV Healthcare, Research Triangle Park, North Carolina, USA.
Jonathan WrightGlaxoSmithKline, Brentford, United Kingdom.
Nisha GeorgeGlaxoSmithKline, Bangalore, India.
Brian WynneViiV Healthcare, Research Triangle Park, North Carolina, USA.
Michael AboudViiV Healthcare, Brentford, United Kingdom.
Jean van WykViiV Healthcare, Brentford, United Kingdom.
Kimberly Y SmithViiV Healthcare, Research Triangle Park, North Carolina, USA.
ViiV Healthcare (United Kingdom) · GBCentre Hospitalier de Tourcoing · FRCentre Hospitalier Universitaire de Saint-Pierre · BEFriedrich-Ebert-Stiftung e.V. · DEGlaxoSmithKline (India) · INGlaxoSmithKline (United Kingdom) · GBHospital General Universitario de Alicante Doctor Balmis · ESMcGill University Health Centre · CATriple O Medical Services · USWesley Research Institute · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSwitching to dolutegravir/lamivudine (DTG/3TC) was noninferior to continuing tenofovir alafenamide (TAF)-based regimens for maintaining virologic suppression at week 48 of the TANGO study. Here we present week 144 outcomes (efficacy, safety, weight, and biomarkers).

methodsTANGO is a randomized (1:1, stratified by baseline third agent class), open-label, noninferiority phase 3 study. Virologically suppressed (>6 months) adults with human immunodeficiency virus type 1 (HIV-1) switched to once-daily DTG/3TC or continued TAF-based regimens.

resultsA total of 741 participants received study treatment (DTG/3TC, n = 369; TAF-based regimen, n = 372). At week 144, the proportion of participants with an HIV-1 RNA level ≥50 copies/mL (primary end point, Snapshot; intention-to-treat-exposed population) after switching to DTG/3TC was 0.3% (1 of 369) versus 1.3% (5 of 372) for those continuing TAF-based regimens, demonstrating noninferiority (adjusted treatment difference, -1.1 [95% confidence interval, -2.4 to .2), with DTG/3TC favored in the per-protocol analysis (adjusted treatment difference, -1.1 [-2.3 to -.0]; P = .04). Few participants met confirmed virologic withdrawal criteria (none in the DTG/3TC and 3 in the TAF-based regimen group), with no resistance observed. Drug-related adverse events were more frequent with DTG/3TC (15%; leading to discontinuation in 4%) than TAF-based regimens (5%; leading to discontinuation in 1%) through week 144, but rates were comparable after week 48 (4%; leading to discontinuation in 1% in both groups). Changes from baseline in lipid values generally favored DTG/3TC; no clinical impact on renal function and comparable changes in inflammatory and bone biomarkers across groups were observed.

conclusionsSwitching to DTG/3TC demonstrated noninferior and durable efficacy compared with continuing TAF-based regimens in treatment-experienced adults with HIV-1, with good safety and tolerability, and no resistance through 144 weeks.

Indexed as

Anti-HIV AgentsHIV-1HIV InfectionsAdenineAdultAlanineDolutegravirHeterocyclic Compounds, 3-RingHumansLamivudineLipidsOxazinesPiperazinesPyridonesRNATenofovirAdenineAlanineAnti-HIV AgentsDolutegravirHeterocyclic Compounds, 3-RingLamivudineLipidsOxazinesPiperazinesPyridonesRNATenofovirtenofovir alafenamide2-drug regimendolutegravir/lamivudinedurableintegrase strand transfer inhibitortreatment-experienced

Identifiers

PMID35079789
PMCPMC9639798
OpenAlexW4207018194

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.