Evidence map›Paper›PMID 41313173›Full record

ArticleAntimicrobial agents and chemotherapy2026

The effect of antacid and mineral supplements on bictegravir pharmacokinetics: results from a Phase 1, open-label, drug-drug interaction study.

Priyanka Arora, Jason T Hindman, Steve West, John Ling, Ramesh Palaparthy, Dhananjay D Marathe

2 registry-linked trialsAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in Antimicrobial agents and chemotherapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT05502341 phase2 / phase3active not recruitingnot on this map

An Operationally Seamless Phase 2/3 Randomized, Open-label, Multicenter, Active-Controlled Study to Evaluate the Safety and Efficacy of Bictegravir/Lenacapavir Versus Stable Baseline Regimen in Virologically Suppressed People With HIV-1 on Stable Complex Treatment Regimens

TypeinterventionalSponsorGilead SciencesRan2022 to 2028Enrolled689ConditionsHIV-1-infectionArmsBictegravir, Lenacapavir, BIC/LEN FDC, Stable Baseline Regimen
NCT06333808 phase3active not recruitingnot on this map

Phase 3 Double-blind Multicenter Randomized Active-Controlled Study to Evaluate the Safety and Efficacy of Bictegravir/Lenacapavir Versus Biktarvy® (Bictegravir/Emtricitabine/Tenofovir Alafenamide) in Virologically Suppressed People With HIV-1

TypeinterventionalSponsorGilead SciencesRan2024 to 2029Enrolled577ConditionsHIV-1-infectionArmsBictegravir, Lenacapavir, B/F/TAF, Placebo to match B/F/TAF, Placebo to match BIC/LEN
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. 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

6 authors.

Priyanka AroraGilead Sciences, Inc., Foster City, California, USA.ORCID 0009-0003-8894-892X
Jason T HindmanGilead Sciences, Inc., Foster City, California, USA.ORCID 0000-0003-1513-3423
Steve WestGilead Sciences, Inc., Foster City, California, USA.
John LingGilead Sciences, Inc., Foster City, California, USA.
Ramesh PalaparthyGilead Sciences, Inc., Foster City, California, USA.
Dhananjay D MaratheGilead Sciences, Inc., Foster City, California, USA.ORCID 0000-0003-0238-2252

Funding

Gilead Sciences, Inc.
6 · The paper itself

Abstract

The mechanism of action of integrase strand transfer inhibitors involves binding to magnesium ions in the active site of the HIV integrase enzyme, making them susceptible to chelation-type drug-drug interactions with metal cation-containing medications. This study evaluated the potential of metal cation-containing antacids and mineral supplements to impact bictegravir (BIC) exposure and assessed alternative approaches for combined use. This was an open-label, single-dose, Phase 1 study in adult participants without HIV. The pharmacokinetics and safety of BIC (administered as part of a single-tablet combination with emtricitabine [F] and tenofovir alafenamide [TAF; B/F/TAF]) were assessed when co-administered with maximum-strength aluminum/magnesium-containing antacid (referred to as "aluminum/magnesium-containing antacid"), calcium carbonate, or ferrous fumarate under fasted and fed conditions, and administered 2 hours before or after the antacid. Pharmacokinetic parameters were compared using analysis of variance to calculate geometric least-squares mean ratios and 90% confidence intervals. Forty-two participants were enrolled. BIC exposure (area under the plasma concentration-time curve extrapolated to infinity) was reduced by 79%, 33%, and 63%, respectively, when co-administered with aluminum/magnesium-containing antacid, calcium carbonate, and ferrous fumarate under fasted conditions. Co-administration of B/F/TAF with calcium carbonate or ferrous fumarate with a meal and administration of B/F/TAF 2 hours before the antacid reduced the impact of the interactions. B/F/TAF was well tolerated alone or in combination with metal cation-containing medications. Co-administration of BIC and calcium/iron-containing supplements with a meal and administration of BIC 2 hours or more before aluminum/magnesium-containing antacids are some of the effective strategies to mitigate chelation effects on BIC exposure.This study was registered at NCT05502341/NCT06333808.

Indexed as

AntacidsHeterocyclic Compounds, 4 or More RingsHIV Integrase InhibitorsMineralsAdenineAdultAlanineAmidesAnti-HIV AgentsDietary SupplementsDrug InteractionsEmtricitabineFemaleHeterocyclic Compounds, 3-RingHumansMaleAdenineAlanineAmidesAntacidsAnti-HIV AgentsbictegravirEmtricitabineHeterocyclic Compounds, 3-RingHeterocyclic Compounds, 4 or More RingsHIV Integrase InhibitorsMineralsPiperazinesPyridonesTenofovirtenofovir alafenamidebictegravirdrug–drug interactionshuman immunodeficiency virusintegrase strand transfer inhibitormetal cationspharmacokinetics

Identifiers

PMID41313173
PMCPMC12777568

What OpenQuestion holds

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LicenceCC BY
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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.