Evidence map›Paper›PMID 40284953›Full record

Trial reportViruses2025

Bictegravir/Emtricitabine/Tenofovir Alafenamide in Adults with HIV/HBV Coinfection: An Open-Label, Single-Arm, Safety and Efficacy Switch Study.

Helena Kwakwa, Jacqueline Bran, Julia Ruff, Salma Sharaf, Hyunuk Seung, Sunny Choe, Joel V Chua

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

Trial report in Viruses, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

7 authors.

Helena KwakwaNewlands Health, Philadelphia, PA 19114, USA.
Jacqueline BranInstitute of Human Virology, University of Maryland School of Medicine, Baltimore, MD 21201, USA.
Julia RuffNewlands Health, Philadelphia, PA 19114, USA.
Salma SharafInstitute of Human Virology, University of Maryland School of Medicine, Baltimore, MD 21201, USA.
Hyunuk SeungDepartment of Practice, Sciences, and Health Outcomes Research, University of Maryland School of Pharmacy, Baltimore, MD 21201, USA.
Sunny ChoeGilead Sciences, Inc., Foster City, CA 94404, USA.
Joel V ChuaInstitute of Human Virology, University of Maryland School of Medicine, Baltimore, MD 21201, USA.ORCID 0000-0002-7579-4672

Funding

Gilead Sciences (United States) CO-US-380-5423
6 · The paper itself

Abstract

backgroundHIV and hepatitis B virus (HBV) coinfection has been associated with a higher risk of morbidity and mortality. HBV-active antiretroviral regimens have significantly improved the outcomes for coinfected people. Although bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) is safe and efficacious for the treatment of HIV, there are few randomized studies on the treatment of HIV/HBV coinfection.

methodsThis open-label switch study enrolled adults with HIV/HBV coinfection from two clinical centers. The participants were switched from their current antiretroviral regimen (regardless of viral suppression) to BIC/FTC/TAF, taken once daily for 48 weeks. The primary endpoints were the proportion of participants with HIV RNA < 50 copies/mL and HBV DNA < 29 IU/mL at Week 24.

resultsTwenty-eight participants were enrolled, with a median age of 51 years; the majority were Black (89%) and male (86%). At baseline, 71% (20/28) and 79% (22/28) were HIV- and HBV-suppressed, respectively, and 64% (18/28) exhibited suppression for both. At week 24, 89% (25/28) and 86% (24/28) were HIV- and HBV-suppressed, respectively, and 82% (23/28) exhibited suppression for both. The most common treatment-related adverse event was nausea (2/28). None of the participants discontinued the treatment due to an adverse event. No serious adverse events or hepatitis flares were observed.

conclusionBIC/FTC/TAF is a safe and suitable option for the treatment of HIV/HBV-coinfected patients.

Indexed as

Anti-HIV AgentsCoinfectionEmtricitabineHepatitis BHIV InfectionsTenofovirAdenineAdultAlanineAmidesAntiviral AgentsFemaleHepatitis B virusHeterocyclic Compounds, 3-RingHeterocyclic Compounds, 4 or More RingsHumansAdenineAlanineAmidesAnti-HIV AgentsAntiviral AgentsbictegravirEmtricitabineHeterocyclic Compounds, 3-RingHeterocyclic Compounds, 4 or More RingsPiperazinesPyridonesTenofovirtenofovir alafenamidebictegravirhepatitis BHIVHIV-HBV coinfectiontenofovir alafenamide

Identifiers

PMID40284953
PMCPMC12030933

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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 OpenQuestion graph.