Evidence map›Paper›PMID 39286902›Full record

Trial reportHIV medicine2025

DORA: 48-week weight and metabolic changes in Black women with HIV, in a phase IIIb switch study from dolutegravir- or efavirenz- to doravirine-based first-line antiretroviral therapy.

Joana Woods, Simiso Sokhela, Godspower Akpomiemie, Bronwyn Bosch, Karlien Möller, Esther Bhaskar, Chelsea Kruger, Ncomeka Manentsa, Noxolo Tom, Philadelphia Macholo and 4 more

Abstract readClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in HIV medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the 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.

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

5 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Article
  4. Review
  5. 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

14 authors.

Joana WoodsWits Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.ORCID https://orcid.org/0000-0003-3507-3800
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.
Bronwyn BoschWits Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Karlien MöllerWits Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Esther BhaskarWits Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Chelsea KrugerWits Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Ncomeka ManentsaWits Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Noxolo TomWits Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Philadelphia MacholoWits 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.
Andrew HillDepartment of Pharmacology and Therapeutics, University of Liverpool, Liverpool, UK.
Michelle MoorhouseWits Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Willem D F VenterWits Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.ORCID https://orcid.org/0000-0002-4157-732X

Funding

MSD Sharp and Dohme
6 · The paper itself

Abstract

objectivesTreatment-related weight gain and metabolic complications with antiretroviral integrase-based regimens, especially among Black women, suggest the need for alternative options.

methodsWe conducted a 48-week, open-label, single-arm, single-centre, phase IIIb switch study to evaluate the tolerability, safety and efficacy of switching from stable efavirenz- or dolutegravir-based antiretroviral therapy to doravirine/lamivudine/tenofovir disoproxil fumarate in Black women.

resultsThe 101 participants enrolled (median age 35 years; interquartile range 31-40) were on efavirenz (n = 46; mean duration on therapy 1.7 years) or dolutegravir-based (n = 55; mean duration 1.5 years) antiretrovirals at screening. Retention at 48 weeks was 92/101 participants, and viral suppression was >90% throughout the study, with a single case of doravirine resistance (106 M, V108I and H221Y mutations). The mean weight percentage change at week 48 was 4.7% (95% confidence interval [CI] 3.0-6.5; p < 0.001), and the adjusted mean change was 2.7 kg (95% CI 1.50-3.98; p < 0.001); for efavirenz, the percentage change was 5.0% (95% CI 2.9-7.1; p < 0.001), and the adjusted weight gain was 3.5 kg (95% CI 1.93-5.13); for dolutegravir, the percentage change was 4.5% (95% CI 1.8-7.3; p < 0.001), and the adjusted weight gain was 2.1 kg (95% CI 0.26-3.90). Statistically significant decreases in lipid panel percent mean to week 48 included: total cholesterol -8.4% (95% CI -11.3 to -5.5; p < 0.001), triglycerides -10.4% (95% CI -16.4 to -4.4; p < 0.001) and high-density lipoprotein -14.8% (95% CI -18.5 to -11.2%; p < 0.001), with minor differences when disaggregating the mean percent change in lipids between previous efavirenz/dolutegravir regimens. Adverse events due to doravirine were few and mild.

conclusionsOur findings suggest that a switch to doravirine from efavirenz or dolutegravir is safe and effective in Black women, with significant improvement in lipid profiles, but does not arrest progressive weight gain.

Indexed as

Anti-HIV AgentsBenzoxazinesHeterocyclic Compounds, 3-RingHIV InfectionsPyridonesTriazolesWeight GainAdultAlkynesBlack or African AmericanCyclopropanesDolutegravirFemaleHumansLamivudineOxazinesAlkynesAnti-HIV AgentsBenzoxazinesCyclopropanesDolutegravirdoravirineefavirenzHeterocyclic Compounds, 3-RingLamivudineOxazinesPiperazinesPyridonesTenofovirTriazolesantiretroviralblackdoravirinefemalemetabolic

Identifiers

PMID39286902
PMCPMC11725414

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

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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.