Evidence map›Paper›PMID 39370144›Full record

Trial reportHIV medicine2025

Bictegravir/emtricitabine/tenofovir alafenamide in adults with HIV-1 and end-stage kidney disease on chronic haemodialysis.

Joseph J Eron, Moti Ramgopal, Olayemi Osiyemi, Mehri Mckellar, Jihad Slim, Edwin DeJesus, Priyanka Arora, Christiana Blair, Jason T Hindman, Aimee Wilkin

Registry-linked trialAbstract readMulticenter StudyClinical 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. It is linked to trial NCT02600819 (A Phase 3b Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of E/C/F/TAF Fixed Dose Combination), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

NCT02600819 phase3completednot on this map

A Phase 3b Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of E/C/F/TAF Fixed Dose Combination (FDC) in HIV-1 Infected Subjects on Chronic Hemodialysis

TypeinterventionalSponsorGilead SciencesRan2015 to 2019Enrolled55ConditionsHIV-1 InfectionArmsE/C/F/TAF, B/F/TAF
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Trial
  3. Article
  4. 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

10 authors.

Joseph J EronThe University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.ORCID https://orcid.org/0000-0002-4938-0644
Moti RamgopalMidway Research Center, Fort Pierce, Florida, USA.
Olayemi OsiyemiTriple O Research Institute P.A, West Palm Beach, Florida, USA.
Mehri MckellarDuke University Medical Center, Durham, North Carolina, USA.
Jihad SlimNew York Medical College, Valhalla, New York, USA.
Edwin DeJesusOrlando Immunology Center, Orlando, Florida, USA.
Priyanka AroraGilead Sciences, Inc., Foster City, California, USA.
Christiana BlairGilead Sciences, Inc., Foster City, California, USA.
Jason T HindmanGilead Sciences, Inc., Foster City, California, USA.
Aimee WilkinWake Forest University, Winston-Salem, North Carolina, USA.

Funding

Gilead Sciences
6 · The paper itself

Abstract

introductionTreatment for people with HIV-1 and end-stage kidney disease (ESKD) on haemodialysis (HD) has previously required complex dose-adjusted regimens, with limited data on the use of a single-tablet regimen in this population. Our aim was to assess the efficacy and safety of once-daily bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) and to evaluate the pharmacokinetics of bictegravir (BIC) in adults with HIV-1 and ESKD on HD.

methodsWe performed an open-label extension (OLE) of an open-label, multicentre, single-group phase 3b study (NCT02600819) of adults with ESKD on HD and HIV-1 with virological suppression. Participants switched to elvitegravir/cobicistat/F/TAF (E/C/F/TAF) 150/150/200/10 mg for 96 weeks, following which a subgroup of US participants entered an OLE phase in which they switched to B/F/TAF 50/200/25 mg for 48 weeks, returning for study visits at weeks 4 and 12, and every 12 weeks thereafter. Study assessments included virological response, safety and pharmacokinetic analysis of BIC.

resultsTen participants entered the OLE (median age, 55 years). Virological suppression (HIV-1 RNA <50 copies/mL) was maintained in all participants over 48 weeks of B/F/TAF treatment. B/F/TAF was well tolerated, with no treatment discontinuations. Mean BIC trough concentrations were lower than those previously reported for people with HIV-1 with normal kidney function, but remained four- to seven-fold higher than the established protein-adjusted 95% effective concentration against wild-type HIV-1.

conclusionThese findings support the use of the once-daily B/F/TAF single-tablet regimen for people with HIV-1 and ESKD on HD. This regimen offers a convenient treatment option for this population as it reduces the need for dose adjustment, eases pill burden and avoids potential drug-drug interactions associated with alternatives that may impact individuals on multiple medications or awaiting transplantation.

Indexed as

Anti-HIV AgentsEmtricitabineHeterocyclic Compounds, 4 or More RingsHIV InfectionsKidney Failure, ChronicTenofovirAdenineAdultAgedAlanineAmidesDrug CombinationsFemaleHeterocyclic Compounds, 3-RingHIV-1HumansAdenineAlanineAmidesAnti-HIV AgentsbictegravirDrug CombinationsEmtricitabineHeterocyclic Compounds, 3-RingHeterocyclic Compounds, 4 or More RingsPiperazinesPyridonesTenofovirtenofovir alafenamideB/F/TAFend‐stage kidney diseasehaemodialysisHIV‐1pharmacokineticssafety

Identifiers

PMID39370144
PMCPMC11786611

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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.