Evidence map›Paper›PMID 38529213›Full record

ArticleOpen forum infectious diseases2024

Final 192-Week Efficacy and Safety Results of the ADVANCE Trial, Comparing 3 First-line Antiretroviral Regimens.

Simiso Sokhela, Willem D F Venter, Bronwyn Bosch, Joana Woods, Kaitlyn McCann, Godspower Akpomiemie, Nomathemba Chandiwana, Nkuli Mashabane, Angela Tembo, Bryony Simmons and 16 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Open forum infectious diseases, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06602622 (Change in Body Weight and BMI in PWH Virologically Suppressed Who Maintain a Second-generation INSTI Regimen Compared to Those Who Switch to DOR/3TC/TDF At 48 Weeks), which is not on this map. Cited by 24 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 1 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.

NCT06602622 phase4recruitingnot on this map

Change in Body Weight and BMI in PWH Virologically Suppressed Who Maintain a Second-generation INSTI Regimen Compared to Those Who Switch to DOR/3TC/TDF At 48 Weeks

TypeinterventionalSponsorInstituto Mexicano del Seguro SocialRan2024 to 2025Enrolled108ConditionsHIV, HIV Associate Weight Loss, HIV-1 Infection, Integrase Inhibitors, HIVArmsIntegrase inhibitor, Doravirine + tenofovir DF + lamivudine
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 1 synthesis or guideline pooled it, 31 citations in OpenAlex.

  1. Pooled it
  2. Hypertension in a Randomized Trial of Dolutegravir- Versus Efavirenz-Based Antiretroviral Therapy in Pregnant and Postpartum Women with HIV.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026
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  19. Short and Long-term Body Weight Change Following the Switch to or the Addition of Integrase Inhibitors in Persons With HIV Differs by Sex.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
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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

26 authors at 8 institutions in 4 countries.

Simiso SokhelaWits Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.ORCID https://orcid.org/0000-0002-2707-1533
Willem D F VenterWits Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.ORCID https://orcid.org/0000-0002-4157-732X
Bronwyn BoschWits Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Joana WoodsWits Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Kaitlyn McCannSchool of Public Health, Imperial College London, London, UK.
Godspower AkpomiemieWits Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Nomathemba ChandiwanaWits Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Nkuli MashabaneWits Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Angela TemboWits Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Bryony SimmonsLSE Health, London School of Economics and Political Science, Imperial College London, London, UK.
Samanta Lalla-EdwardWits Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Mark J SiednerAfrica Health Research Institute, KwaZulu-Natal, South Africa.
Phumla SinxadiDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.
Lucas HermansWits Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Lee FairlieWits RHI, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Alinda VosWits Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Elaine AbramsMailman School of Public Health and Department of Pediatrics, Vagelos College of Physicians and Surgeons, ICAP at Columbia University, Columbia University, New York, New York, USA.
Jennifer M Manne-GoehlerDivision of Infectious Diseases, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Michelle MoorhouseViiV Healthcare, Johannesburg, South Africa.
Polly ClaydenHIV i-Base, London, UK.
Shane NorrisSouth African Medical Research Council, Developmental Pathways for Health Research Unit, Department of Pediatrics, University of the Witwatersrand, Johannesburg, South Africa.
Ambar QaviSchool of Public Health, Imperial College London, London, UK.
Matthew ChersichMedical Microbiology, University Medical Center Utrecht, Utrecht, the Netherlands.
Masebole MasenyaMedical Microbiology, University Medical Center Utrecht, Utrecht, the Netherlands.
Natasha ArulappanWits Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Andrew HillDepartment of Translational Medicine, Liverpool University, Liverpool, UK.
University of the Witwatersrand · ZAImperial College London · GBSouth African Medical Research Council · ZAUniversity Medical Center Utrecht · NLBrigham and Women's Hospital · USColumbia University · USHarvard University · USUniversity of Liverpool · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: ADVANCE compared 3 World Health Organization-recommended first-line regimens in participants with HIV who were antiretroviral naive. Methods: This randomized, open-label, noninferiority trial enrolled participants living with HIV with no antiretroviral exposure in the previous 6 months to 1 of the following arms: tenofovir alafenamide (TAF) / emtricitabine (FTC) + dolutegravir (DTG) (2 tablets), tenofovir disoproxil fumarate (TDF) / FTC + DTG (2 tablets), or a fixed-dose combination of TDF / FTC / efavirenz (EFV) (1 tablet). We report the final safety and efficacy data up to 192 weeks. Results: Repeat consent from the original 351 participants randomized to each arm was obtained from 230 participants (66%) in the TAF/FTC + DTG arm, 209 (60%) in the TDF/FTC + DTG arm, and 183 (52%) in the TDF/FTC/EFV arm. At 192 weeks, 213 (61%) of the original 351 participants in the TAF/FTC + DTG arm, 195 (56%) in the TDF/FTC + DTG arm, and 172 (49%) in the TDF/FTC/EFV arm had confirmed RNA <50 copies/mL, with low virologic failure in all groups and no significant integrase inhibitor mutations in any arm. Mean weight gain was 8.9 kg (SD, 7.1) in the TAF/FTC + DTG arm, 5.9 kg (SD, 7.1) in the TDF/FTC + DTG arm, and 3.2 kg (SD, 8.1) in the TDF/FTC/EFV arm at 192 weeks from baseline and was greatest among women, those taking TAF, and those with lower baseline CD4 counts. The weight trajectory slowed after week 96. There were few clinical events and minor laboratory changes and differences among arms after 96 weeks. There were no significant differences in treatment-emergent hypertension or pregnancy outcomes by arm. Conclusions: High viral suppression was seen across arms, with no resistance to DTG. Weight gain continued but slowed after 96 weeks, with few clinical events or laboratory changes.

Indexed as

dolutegravirobesityresistancesuppressiontenofovir

Identifiers

PMID38529213
PMCPMC10962246
OpenAlexW4391211869

What OpenQuestion holds

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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.