Evidence map›Paper›PMID 38978403›Full record

Trial reportJournal of the International AIDS Society2024

Blood pressure increases are associated with weight gain and not antiretroviral regimen or kidney function: a secondary analysis from the ADVANCE trial in South Africa.

Jennifer Manne-Goehler, June Fabian, Simiso Sokhela, Godspower Akpomiemie, Nicholas Rahim, Samanta Tresha Lalla-Edward, Alana T Brennan, Mark J Siedner, Andrew Hill, Willem Daniel Francois Venter

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of the International AIDS Society, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03122262 (WRHI 060), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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.

NCT03122262 phase3completednot on this map

WRHI 060 (ADVANCE): A Randomised, Phase 3 Non-inferiority Study of DTG + TAF + FTC Compared With DTG + TDF + FTC and EFV + TDF + FTC in Patients Infected With HIV-1 Starting First-line Antiretroviral Therapy - Extension to 192 Weeks

TypeinterventionalSponsorProfessor Francois VenterRan2017 to 2022Enrolled1,110ConditionsHIV-1 InfectionArmsDolutegravir, Tenofovir Alafenamide, Truvada, Atripla
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Article
  2. High levels of elevated blood pressure among pregnant and postpartum women with HIV, regardless of dolutegravir initiation.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026
    Article
  3. Article
  4. Article
  5. Incident Hypertension with Antiretroviral Therapy in the OPERA Cohort.Journal of the International Association of Providers of AIDS Care
    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

10 authors.

Jennifer Manne-Goehler *Medical Practice Evaluation Center, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.ORCID https://orcid.org/0000-0001-9295-0035
June Fabian *Wits Donald Gordon Medical Centre, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Simiso SokhelaWits Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Godspower AkpomiemieWits Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Nicholas RahimMedical Practice Evaluation Center, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Samanta Tresha Lalla-EdwardWits Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Alana T BrennanDepartment of Global Health, Boston University School of Public Health, Boston, Massachusetts, USA.ORCID https://orcid.org/0000-0002-7746-0668
Mark J SiednerMedical Practice Evaluation Center, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Andrew HillUniversity of Liverpool, Liverpool, UK.
Willem Daniel Francois VenterWits Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.

Funding

NIDDK NIH HHS K01 DK116929NIDDK NIH HHS K01DK116929NIDDK NIH HHS K23125162NIDDK NIH HHS K23 DK125162SA MRC, UNITAID, USAID, ViiV Healthcare
6 · The paper itself

Abstract

introductionRecent evidence has raised questions about whether newer HIV treatment regimens, including dolutegravir (DTG) and tenofovir alafenamide (TAF), are associated with increases in blood pressure (BP).

methodsWe assessed changes in BP by treatment regimen and evaluated the relative contribution of kidney function and weight gain to these changes among participants in the ADVANCE phase-3 trial clinical trial in South Africa (study dates: January 2017-February 2022). Our primary outcome of interest was a change in systolic BP (SBP) at 96 and 192 weeks, among those not receiving antihypertensive medication. The secondary outcome was treatment-emergent hypertension at these same time points, defined as BP ≥140/90 mmHg on two occasions, or initiation of antihypertensive medication after week 4 among individuals without hypertension at enrolment. We used linear regression to evaluate the relationship between change in estimated glomerular filtration rate (eGFR) and change in SBP; and Poisson regression to evaluate the relationship between change in eGFR and treatment-emergent hypertension at each time point. All models were adjusted for age, sex, treatment group and change in body mass index (BMI).

resultsOver 96 weeks, the average changes in SBP were 1.7 mmHg (95% CI: 0.0-3.4), -0.5 mmHg (95% CI: -2.2 to 1.7) and -2.1 mmHg (95% CI: -3.8 to 0.4) in the TAF/emtricitabine (FTC)/DTG, tenofovir disoproxil fumarate (TDF)/FTC/DTG and TDF/FTC/efavirenz (EFV) groups, respectively. This difference was significant for the TAF/FTC/DTG compared to the TDF/FTC/EFV group (p = 0.002). Over 96 weeks, 18.2% (95% CI: 13.4-22.9), 15.4% (95% CI: 11.0-19.9) and 13.3% (95% CI: 8.9-17.6) of participants developed treatment-emergent hypertension, respectively. In adjusted models, there was no significant relationship between change in eGFR and either outcome. Change in BMI was significantly associated with an increase in SBP, while age was associated with an increased risk of treatment-emergent hypertension. Adjustment for BMI also mitigated the unadjusted relationship between HIV treatment regimen and SBP where present.

conclusionsIn the ADVANCE cohort, weight gain and age accounted for increases in BP and risk of treatment-emergent hypertension. HIV treatment programmes may need to integrate the management of obesity and hypertension into routine care. CLINICAL TRIAL NUMBER: NCT03122262.

Indexed as

Blood PressureHIV InfectionsHypertensionTenofovirWeight GainAdultAlanineAnti-HIV AgentsDolutegravirFemaleGlomerular Filtration RateHeterocyclic Compounds, 3-RingHumansMaleMiddle AgedOxazinesAlanineAnti-HIV AgentsDolutegravirHeterocyclic Compounds, 3-RingOxazinesPiperazinesPyridonesTenofovirtenofovir alafenamidedolutegravirHIVhypertensionkidney functionobesitytenofovir alafenamide

Identifiers

PMID38978403
PMCPMC11231445

What Socratic 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 Socratic graph.