Evidence map›Paper›PMID 33587500›Full record

Trial reportJournal of acquired immune deficiency syndromes (1999)2021

Brief Report: Improvement in Metabolic Health Parameters at Week 48 After Switching From a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen to the 2-Drug Regimen of Dolutegravir/Lamivudine: The TANGO Study.

Jean van Wyk, Mounir Ait-Khaled, Jesus Santos, Stefan Scholten, Michael Wohlfeiler, Faïza Ajana, Bryn Jones, Maria-Claudia Nascimento, Allan R Tenorio, Don E Smith and 2 more

Open access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of acquired immune deficiency syndromes (1999), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
6.3field-weighted citation impact, top 3% 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.

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

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 30 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Article
  6. Article
  7. Review
  8. Article
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  11. Article
  12. Trajectories of CD4Viruses · 2022
    Observational
  13. Article
  14. Review
  15. Cell cycle (Georgetown, Tex.)
    Article
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

12 authors at 6 institutions in 5 countries.

Jean van WykViiV Healthcare, Brentford, United Kingdom.
Mounir Ait-KhaledViiV Healthcare, Brentford, United Kingdom.
Jesus SantosInfectious Diseases Unit, Hospital Virgen de la Victoria, Málaga, Spain.
Stefan ScholtenPraxis Hohenstaufenring, Cologne, Germany.
Michael WohlfeilerAIDS Healthcare Foundation, Miami Beach, FL.
Faïza AjanaInfectious Diseases, Centre Hospitalier de Tourcoing, Tourcoing, France.
Bryn JonesViiV Healthcare, Brentford, United Kingdom.
Maria-Claudia NascimentoViiV Healthcare, Brentford, United Kingdom.
Allan R TenorioViiV Healthcare, Research Triangle Park, NC.
Don E SmithAlbion Centre, Sydney, Australia; and.
Jonathan WrightStatistics, GlaxoSmithKline, Stockley Park, United Kingdom.
Brian WynneViiV Healthcare, Research Triangle Park, NC.
ViiV Healthcare (United Kingdom) · GBTriangle · USAIDS Healthcare Foundation · USAlbion Centre · AUCentre Hospitalier de Tourcoing · FRHospital Clínico Universitario Virgen de la Victoria · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn TANGO, switching to dolutegravir/lamivudine was noninferior at 48 weeks to continuing 3-/4-drug tenofovir alafenamide-based regimens in virologically suppressed individuals with HIV-1. Antiretroviral agents have been associated with weight gain and metabolic complications.

settingOne hundred thirty-four centers; 10 countries.

methodsWe assessed weight; fasting lipids, glucose, and insulin; and prevalence of insulin resistance and metabolic syndrome at baseline and week 48 in TANGO participant subgroups by boosting agent use in baseline regimens (boosted and unboosted).

resultsIn each treatment group, 74% of participants used boosted regimens at baseline. In boosted and unboosted subgroups, weight and fasting glucose changes at week 48 were small and similar between treatment groups. Overall and in the boosted subgroup, greater decreases from baseline were observed with dolutegravir/lamivudine in fasting total cholesterol (P < 0.001), low-density lipoprotein cholesterol (P < 0.001), triglycerides (P < 0.001), total cholesterol/high-density lipoprotein cholesterol ratio (overall, P = 0.017; boosted, P = 0.007), and insulin (boosted, P = 0.005). Prevalence of HOMA-IR ≥2 was significantly lower at week 48 with dolutegravir/lamivudine overall [adjusted odds ratio (aOR), 0.59; 95% confidence interval (CI), 0.40 to 0.87; P = 0.008] and in the boosted subgroup [aOR, 0.56; 95% CI, 0.36 to 0.88; P = 0.012] but not in the unboosted subgroup [aOR, 0.70; 95% CI, 0.31 to 1.58; P = 0.396]. Prevalence of metabolic syndrome at week 48 was low and consistent between treatment groups overall, with differences trending to favor dolutegravir/lamivudine in the unboosted subgroup [aOR, 0.41; 95% CI, 0.15 to 1.09; P = 0.075].

conclusionGenerally, switching from 3-/4-drug tenofovir alafenamide-based regimens to dolutegravir/lamivudine improved metabolic parameters, particularly when switching from boosted regimens. Because of smaller sample size in the unboosted subgroup, results warrant further investigation.

Indexed as

AdultAlanineAnti-HIV AgentsAntiretroviral Therapy, Highly ActiveBlood GlucoseDolutegravirDrug Therapy, CombinationHeterocyclic Compounds, 3-RingHIV-1HIV InfectionsHumansInsulin ResistanceLamivudineLipidsMetabolic SyndromeOxazinesAlanineAnti-HIV AgentsBlood GlucoseDolutegravirHeterocyclic Compounds, 3-RingLamivudineLipidsOxazinesPiperazinesPyridonesTenofovirtenofovir alafenamide

Identifiers

PMID33587500
PMCPMC8126488
OpenAlexW3132740932

What OpenQuestion 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 OpenQuestion graph.