Evidence map›Paper›PMID 33964099›Full record

ArticleHIV medicine2021

Tolerability of four-drug antiretroviral combination therapy in primary HIV-1 infection.

J E Burns, W Stöhr, S Kinloch-De Loes, J Fox, A Clarke, M Nelson, J Thornhill, A Babiker, J Frater, S L Pett and 1 more

Open access · hybridAbstract read
In one paragraph

Article in HIV medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.3field-weighted citation impact, top 43% 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

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Review
  2. In vitro model to simulate multiple drugs with distinct elimination half-lives.International journal of antimicrobial agents · 2023
    Article
  3. 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

11 authors at 8 institutions in 1 country.

J E BurnsCentre for Clinical Research in Infection and Sexual Health, Institute for Global Health, University College London, London, UK.ORCID 0000-0003-3282-4998
W StöhrMedical Research Council Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK.
S Kinloch-De LoesDepartment of Infection and Immunity, Royal Free Hospital, London, UK.
J FoxDepartment of Genitourinary Medicine and Infectious Diseases, Guys and St, Thomas' NHS Trust, London, UK.
A ClarkeElton John Centre, Brighton, UK.
M NelsonDepartment of HIV Medicine, Chelsea and Westminster Hospital, Imperial College London, London, UK.
J ThornhillDepartment of Infectious Disease, Imperial College London, London, UK.
A BabikerMedical Research Council Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK.
J FraterNuffield Department of Medicine, Oxford University, Oxford, UK.
S L PettCentre for Clinical Research in Infection and Sexual Health, Institute for Global Health, University College London, London, UK.
S FidlerDepartment of Infectious Disease, Imperial College London, London, UK.
MRC Clinical Trials Unit at UCL · GBNIHR Imperial Biomedical Research Centre · GBBrighton and Sussex Medical School · GBChelsea and Westminster Hospital · GBGuy's Hospital · GBThe Royal Free Hospital · GBUniversity College London · GBUniversity of Oxford · GB

Funding

Medical Research Council MR/L00528X/1Medical Research Council MR/L006588/1Medical Research Council MR/N001265/1Medical Research Council MR/P011233/1
6 · The paper itself

Abstract

objectivesRapid initiation of antiretroviral therapy (ART) is important for individuals with high baseline viral loads, such as in primary HIV-1 infection (PHI). Four-drug regimens are sometimes considered; however, data are lacking on tolerability. We aimed to evaluate the tolerability of four-drug regimens used in the Research in Viral Eradication of HIV-1 Reservoirs (RIVER) study.

methodsAt enrolment, ART-naïve adult participants or those newly commenced on ART were initiated or intensified to four-drug regimens within 4 weeks of PHI. Rapid start was defined as pre-confirmation or ≤ 7 days of confirmed diagnosis. Primary and secondary outcomes were patient-reported adherence measured by 7-day recall and regimen switches between enrolment and randomization, respectively.

resultsOverall, 54 men were included: 72.2% were of white ethnicity, with a median age of 32 years old, 42.6% had a viral load of ≥ 100 000 HIV-1 RNA copies/mL, and in 92.6% sex with men was the mode of acquisition of HIV-1. Twenty (37%) started a four-drug regimen and 34 (63%) were intensified. Rapid ART initiation occurred in 28%, 100% started in ≤ 4 weeks. By weeks 4, 12, and 24, 37.0%, 69.0%, and 94.0% were undetectable (viral load < 50 copies/mL), respectively. Adherence rates of 100% at weeks 4, 12, 22 and 24 were reported in 88.9%, 87.0%, 82.4% and 94.1% of participants, respectively. Five individuals switched to three drugs, four changed their regimen constituents, and two switched post-randomization.

conclusionsOverall, four-drug regimens were well tolerated and had high levels of adherence. Whilst their benefit over three-drug regimens is lacking, our findings should provide reassurance if a temporarily intensified regimen is clinically indicated to help facilitate treatment.

Indexed as

Anti-HIV AgentsHIV-1HIV InfectionsAdultAnti-Retroviral AgentsDrug Therapy, CombinationHumansMaleViral LoadAnti-HIV AgentsAnti-Retroviral Agentsadherenceantiretroviral therapyprimary HIV-1 infectiontolerability

Identifiers

PMID33964099
PMCPMC8612356
OpenAlexW3159473083

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.