Evidence map›Paper›PMID 39556192›Full record

Trial reportThe Journal of antimicrobial chemotherapy2025

Efficacy of bictegravir/emtricitabine/tenofovir alafenamide versus dolutegravir-based three-drug regimens in people with HIV with varying adherence to antiretroviral therapy.

Kristen Andreatta, Paul E Sax, David Wohl, Michelle L D'Antoni, Hui Liu, Jason T Hindman, Christian Callebaut

5 registry-linked trialsAbstract readClinical Trial, Phase IIIComparative StudyEquivalence Trial
In one paragraph

Trial report in The Journal of antimicrobial chemotherapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
–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.

NCT02603120 phase3completednot on this map

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching From a Regimen of Dolutegravir and ABC/3TC, or a Fixed Dose Combination (FDC) of ABC/DTG/3TC to a FDC of GS-9883/F/TAF in HIV-1 Infected Subjects Who Are Virologically Suppressed

TypeinterventionalSponsorGilead SciencesRan2015 to 2019Enrolled567ConditionsHIV-1 InfectionArmsABC/DTG/3TC, B/F/TAF, ABC/DTG/3TC Placebo, B/F/TAF Placebo
NCT02607930 phase3completednot on this map

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9883/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

TypeinterventionalSponsorGilead SciencesRan2015 to 2021Enrolled631ConditionsHIV-1 InfectionArmsABC/DTG/3TC, B/F/TAF, ABC/DTG/3TC Placebo, B/F/TAF Placebo
NCT02607956 phase3completednot on this map

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9883/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

TypeinterventionalSponsorGilead SciencesRan2015 to 2021Enrolled657ConditionsHIV-1 InfectionArmsDTG, F/TAF, B/F/TAF, DTG Placebo, F/TAF Placebo
NCT03110380 phase3completednot on this map

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching From a Regimen of Dolutegravir and Either Emtricitabine/Tenofovir Alafenamide or Emtricitabine/Tenofovir Disoproxil Fumarate to a Fixed Dose Combination of Bictegravir/ Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Subjects Who Are Virologically Suppressed

TypeinterventionalSponsorGilead SciencesRan2017 to 2021Enrolled567ConditionsHIV-1-infectionArmsB/F/TAF, F/TAF, DTG, DTG Placebo, F/TAF Placebo
NCT03547908 phase3completednot on this map

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naïve, HIV-1 and Hepatitis B Co-Infected Adults

TypeinterventionalSponsorGilead SciencesRan2018 to 2024Enrolled244ConditionsHIV-1/HBV Co-InfectionArmsB/F/TAF, Placebo to match DTG, Placebo to match F/TDF, DTG, F/TDF
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Observational
  3. Article
  4. Article
  5. Article
  6. Review
  7. HIV Treatment Paradigm Shifts over the Past 40 Years.Jugan geon-gang gwa jilbyeong · 2025
    Review
  8. Observational
  9. 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

7 authors.

Kristen AndreattaClinical Virology, Gilead Sciences, Inc., Foster City, CA, USA.
Paul E SaxDivision of Infectious Diseases, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
David WohlDivision of Infectious Diseases, University of North Carolina, Chapel Hill, NC, USA.
Michelle L D'AntoniClinical Virology, Gilead Sciences, Inc., Foster City, CA, USA.
Hui LiuBiostatistics Virology, Gilead Sciences, Inc., Foster City, CA, USA.
Jason T HindmanClinical Development, Gilead Sciences, Inc., Foster City, CA, USA.
Christian CallebautClinical Virology, Gilead Sciences, Inc., Foster City, CA, USA.

Funding

Gilead Sciences, Inc
6 · The paper itself

Abstract

objectiveFive Phase 3 bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) clinical studies demonstrated that the efficacy of B/F/TAF was non-inferior to dolutegravir (DTG) + 2 NRTIs. We retrospectively assessed drug adherence and effect on virologic outcomes.

methodsStudies (NCT02607930, NCT02607956, NCT03547908, NCT02603120 and NCT03110380) were double-blind, placebo-controlled and enrolled treatment-naïve or virologically suppressed adults. Adherence was calculated by pill count from returned pill bottles; virologic outcome was assessed by last on-treatment HIV-1 RNA.

resultsAltogether, 2622 participants (B/F/TAF: n = 1306; DTG + 2 NRTIs: n = 1316) were categorized as having high (≥95%), intermediate (≥85% to <95%) or low (<85%) adherence. Through Week 48, low adherence was observed in 46 (3.5%) participants in the B/F/TAF group (78% median adherence) and 69 (5.2%) in the DTG + 2 NRTI group (80% median adherence). Overall, 1287 (98.5%) participants in the B/F/TAF group and 1292 (98.2%) in the DTG + 2 NRTI group had virologic suppression (VS; HIV-1 RNA < 50 copies/mL) through Week 48. VS in participants with low adherence versus high or intermediate adherence was similar in the B/F/TAF group, but lower in the DTG + 2 NRTI group (P ≤ 0.002). Similar results were observed at Weeks 96 and 144. Two participants (<95% adherence) in the DTG + 2 NRTI group receiving DTG and abacavir/lamivudine developed M184V; there was no treatment-emergent resistance to B/F/TAF.

conclusionsParticipants with suboptimal (<85%) adherence to B/F/TAF maintained high levels of VS, whereas suboptimal DTG + 2 NRTI adherence was associated with lower VS.

Indexed as

AdenineAlanineAmidesAnti-HIV AgentsEmtricitabineHeterocyclic Compounds, 3-RingHIV-1HIV InfectionsMedication AdherenceOxazinesPiperazinesPyridonesTenofovirAdultAntiretroviral Therapy, Highly ActiveDolutegravirAdenineAlanineAmidesAnti-HIV AgentsbictegravirDolutegravirDrug CombinationsEmtricitabineHeterocyclic Compounds, 3-RingHeterocyclic Compounds, 4 or More RingsOxazinesPiperazinesPyridonesRNA, ViralTenofovirtenofovir alafenamide

Identifiers

PMID39556192
PMCPMC11695908

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.