Evidence map›Paper›PMID 39930490›Full record

Trial reportVirology journal2025

Outcomes of switching from protease inhibitor-based antiretroviral therapy to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in virologically suppressed adults with nucleos(t)ide analogue resistance- a phase IV randomised, open-label study (PIBIK study).

Collins Iwuji, Laura Waters, Ana Milinkovic, Chloe Orkin, Julie Fox, Frank Post, Nicky Perry, Chloe Bruce, Natalie Dailey, Ye To and 3 more

Abstract readRandomized Controlled TrialClinical Trial, Phase IV
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Virology journal, 2025. 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
–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

3 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
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

13 authors.

Collins IwujiDepartment of Global Health and Infection, Brighton and Sussex Medical School, University of Sussex, Falmer, Brighton, UK. c.iwuji@bsms.ac.uk.
Laura WatersThe Mortimer Market Centre, Central and Northwest London NHS Foundation Trust, London, UK.
Ana MilinkovicChelsea and Westminster Hospital NHS Foundation Trust, London, UK.
Chloe OrkinBlizard Institute, Faculty of Medicine and Dentistry, Queen Mary University of London, London, UK.
Julie FoxGuy's and St Thomas' NHS Foundation Trust, London, UK.
Frank PostKing's College Hospital NHS Foundation Trust, London, UK.
Nicky PerryUniversity Hospitals Sussex NHS Foundation Trust, London, UK.
Chloe BruceBrighton & Sussex Clinical Trials Unit, University of Sussex, Brighton, UK.
Natalie DaileyBrighton & Sussex Clinical Trials Unit, University of Sussex, Brighton, UK.
Ye ToBrighton & Sussex Clinical Trials Unit, University of Sussex, Brighton, UK.
Stephen BremnerBrighton & Sussex Clinical Trials Unit, University of Sussex, Brighton, UK.
Duncan ChurchillUniversity Hospitals Sussex NHS Foundation Trust, London, UK.
Anna Maria GerettiDepartment of Systems Medicine, University of Rome Tor Vergata, Rome, Italy.

Funding

Gilead Sciences IN-UK-380-5352
6 · The paper itself

Abstract

backgroundThere are limited data on how historical nucleoside reverse transcriptase inhibitor (NRTI) resistance-associated mutations (RAMs) other than M184V/I, affect the activity of B/F/TAF. We evaluated the outcomes of switching virologically suppressed (HIV-1 RNA < 50 copies/mL) individuals harbouring major RAMs from boosted protease inhibitor (bPI)-based therapy to B/F/TAF.

methodsParticipants had various historical genotypic patterns including M184V/I, ≤2 thymidine analogue mutations (TAMs), and other NRTI RAMs (NAMs), and no integrase resistance. Baseline RAMs were explored by retrospective sequencing of cellular HIV-1 DNA. Participants were randomised (1:1) to switching to B/F/TAF either immediately or after 24 weeks. The primary outcome was the proportion of participants maintaining virological suppression (pure virologic response) at week-24; secondary outcomes were proportion of participants with virological suppression at week-48, pre-specified safety measures, and treatment-emergent resistance.

resultsHistorically, 21/72 (29.2%) participants had M184V/I, 5 (6.9%) M184V/I + 1 NAM, 31 (43.1%) 1 TAM ± M184V/I ± 1 NAM, and 15 (20.8%) 2 TAMs ± M184V/I ± 1 NAM. At week-24, proportions maintaining virological suppression were 33/33 (100%) on B/F/TAF vs. 38/39 (97.4%) on bPI (difference 2.6%; 95% CI -2.4%, 7.5%). Drug-related adverse events (AEs) were reported in 10/33 (30.3%) vs. 1/39 (2.6%), respectively. The immediate switch arm had improved lipid parameters but increased HbA1c and weight. Virological suppression was maintained at week-48. There were six discontinuations; four on B/F/TAF were drug-related and the two on bPI were not drug-related.

conclusionsHistorical NRTI resistance did not compromise the effectiveness of B/F/TAF in virologically suppressed adults. 12% experienced treatment-limiting AEs after switching. REGISTRATION: EudraCT no: 2018-004732-30.

Indexed as

AdenineAnti-HIV AgentsDrug Resistance, ViralEmtricitabineHeterocyclic Compounds, 4 or More RingsHIV-1HIV InfectionsHIV Protease InhibitorsTenofovirAdultAlanineAmidesAntiretroviral Therapy, Highly ActiveDrug SubstitutionFemaleGenotypeAdenineAlanineAmidesAnti-HIV AgentsbictegravirEmtricitabineHeterocyclic Compounds, 3-RingHeterocyclic Compounds, 4 or More RingsHIV Protease InhibitorsPiperazinesPyridonesTenofovirtenofovir alafenamideArchiveBictegravirBoosted protease inhibitorDrug resistanceHIVIntegrase strand transfer inhibitorSwitchTenofovir alafenamide

Identifiers

PMID39930490
PMCPMC11808997

What Socratic 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 Socratic graph.