Evidence map›Paper›PMID 31692269›Full record

ArticleJournal of the International AIDS Society2019

Transgender women on oral HIV pre-exposure prophylaxis have significantly lower tenofovir and emtricitabine concentrations when also taking oestrogen when compared to cisgender men.

Eugenie Shieh, Mark A Marzinke, Edward J Fuchs, Allyson Hamlin, Rahul Bakshi, Wutyi Aung, Jennifer Breakey, Tonia Poteat, Todd Brown, Namandjé N Bumpus and 1 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of the International AIDS Society, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 49 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
49citing 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.

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

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

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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

11 authors.

Eugenie ShiehDepartment of Medicine (Clinical Pharmacology), Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Mark A MarzinkeDepartment of Medicine (Clinical Pharmacology), Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Edward J FuchsDepartment of Medicine (Clinical Pharmacology), Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Allyson HamlinDepartment of Medicine (Clinical Pharmacology), Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Rahul BakshiDepartment of Medicine (Clinical Pharmacology), Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Wutyi AungDepartment of Medicine (Clinical Pharmacology), Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Jennifer BreakeyDepartment of Medicine (Clinical Pharmacology), Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Tonia PoteatDepartment of Social Medicine, University of North Carolina Chapel Hill, Chapel Hill, North Carolina, USA.
Todd BrownDepartment of Medicine (Endocrinology), Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Namandjé N BumpusDepartment of Medicine (Clinical Pharmacology), Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Craig W HendrixDepartment of Medicine (Clinical Pharmacology), Johns Hopkins University School of Medicine, Baltimore, MD, USA.ORCID 0000-0002-5696-8665

Funding

Vaccine Response and Immunotherapeutics SWGP30AI094189 · NIAID · JOHNS HOPKINS UNIVERSITY · PI Richard E. Chaisson · 2012 to 2026
$67.0M
Institute for Clinical and Translational ResearchUL1TR001079 · NCATS · JOHNS HOPKINS UNIVERSITY · PI FORD, DANIEL ERNEST · 2013 to 2017
$60.1M
JOHNS HOPKINS CENTER FOR AIDS RESEARCHP30AI042855 · NIAID · JOHNS HOPKINS UNIVERSITY · PI BARTLETT, JOHN G · 2000 to 2005
$7.7M
Clinical Pharmacology Training ProgramT32GM066691 · NIGMS · JOHNS HOPKINS UNIVERSITY · PI Matthew Michael Ippolito · 2003 to 2026
$6.4M
Training Program for Scientists Conducting Research to Reduce HIV Health DisparitR25MH067127 · NIMH · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Emily A Arnold, Torsten Brian Neilands · 2003 to 2026
$5.4M
Minority Populations Prevention Researcher TrainingR25HD045810 · NICHD · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI NEILANDS, TORSTEN BRIAN · 2003 to 2018
$4.3M
NCATS NIH HHS UL1 TR001079NIAID NIH HHS P30 AI042855NIAID NIH HHS P30 AI094189NICHD NIH HHS R25 HD045810NIGMS NIH HHS T32 GM066691NIMH NIH HHS R25 MH067127
6 · The paper itself

Abstract

introductionOral HIV Pre-Exposure Prophylaxis (PrEP) with tenofovir (TFV) disoproxil fumarate (TDF)/emtricitabine (FTC) is highly effective. Transgender women (TGW) have increased HIV risk, but have been underrepresented in trials. For TGW on oestrogens for gender-affirming hormone treatment (GAHT), TDF/FTC-oestrogen interactions may negatively affect HIV prevention or gender-affirming goals. Our aim was to evaluate any pharmacokinetic drug-drug interaction between GAHT and TDF/FTC.

methodsWe performed a pharmacokinetic study, in an urban outpatient setting in 2016 to 2018, of the effects of GAHT on TFV, FTC and the active forms TFV diphosphate (TFV-DP) and FTC triphosphate (FTC-TP) in eight TGW and eight cisgender men (CGM). At screening, participants were HIV negative. TGW were to maintain their GAHT regimens and have plasma oestradiol concentrations >100 pg/mL. Under direct observation, participants took oral TDF/FTC daily for seven days. At the last dose, blood was collected pre-dose, one, two, four, six, eight and twenty-four hours, and colon biopsies were collected at 24 hours to measure drug concentration. TGW versus CGM concentration comparisons used non-parametric tests. Blood and colon tissue were also obtained to assess kinase expression.

resultsPlasma TFV and FTC C

conclusionsGAHT modestly reduces both TFV and FTC plasma concentrations. In TGW taking GAHT, it is unknown if this reduction will impact the HIV protective efficacy of a daily PrEP regimen. However, the combination of an on demand (2 + 1 + 1) PrEP regimen and GAHT may result in concentrations too low for reliable prevention of HIV infection.

Indexed as

Pre-Exposure ProphylaxisTransgender PersonsAdultAnti-HIV AgentsDrug InteractionsEmtricitabineEstrogensFemaleHIV InfectionsHumansMaleMiddle AgedTenofovirYoung AdultAnti-HIV AgentsEmtricitabineEstrogensTenofovirdrug-drug interactionemtricitabinegender-affirming hormonal treatmentHIV pre-exposure prophylaxistenofovirtransgender women

Identifiers

PMID31692269
PMCPMC6832671

What OpenQuestion holds

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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 OpenQuestion graph.