Evidence map›Paper›PMID 38312459›Full record

ArticleTransgender health2024

Gender Affirming Hormones Do Not Affect the Exposure and Efficacy of F/TDF or F/TAF for HIV Preexposure Prophylaxis: A Subgroup Analysis from the DISCOVER Trial.

Michelle S Cespedes, Moupali Das, Jenna Yager, Maria Prins, Ivanka Krznaric, Jan de Jong, Deqing Xiao, Yongwu Shao, Pamela Wong, Alexander Kintu and 6 more

Registry-linked trialOpen access · greenAbstract read
In one paragraph

Article in Transgender health, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02842086 (A Phase 3, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.2field-weighted citation impact, top 20% of its field
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.

NCT02842086 phase3active not recruitingnot on this map

A Phase 3, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex With Men and Are At Risk of HIV-1 Infection

TypeinterventionalSponsorGilead SciencesRan2016 to 2026Enrolled5,399ConditionsPre-Exposure Prophylaxis of HIV-1 InfectionArmsF/TAF, F/TDF, F/TAF Placebo, F/TDF Placebo
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 13 citations in OpenAlex.

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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

16 authors at 8 institutions in 3 countries.

Michelle S CespedesDivision of Infectious Disease, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Moupali DasGilead Sciences, Foster City, California, USA.ORCID https://orcid.org/0000-0001-5034-8185
Jenna YagerGilead Sciences, Foster City, California, USA.
Maria PrinsDepartment of Infectious Diseases, Amsterdam Institute for Infection and Immunity, Amsterdam University Medical Centers (UMC), University of Amsterdam, Amsterdam, The Netherlands.
Ivanka KrznaricZentrum für Infektiologie Berlin Prenzlauer Berg, Berlin, Germany.
Jan de JongGilead Sciences, Foster City, California, USA.ORCID https://orcid.org/0000-0003-3247-7981
Deqing XiaoGilead Sciences, Foster City, California, USA.ORCID https://orcid.org/0000-0003-2315-8567
Yongwu ShaoGilead Sciences, Foster City, California, USA.
Pamela WongGilead Sciences, Foster City, California, USA.
Alexander KintuGilead Sciences, Foster City, California, USA.
Christoph CarterGilead Sciences, Foster City, California, USA.
Elske HoornenborgDepartment of Infectious Diseases, Public Health Service of Amsterdam, Amsterdam, The Netherlands.
Peter RuaneRuane Clinical Research Group, Inc., Los Angeles, California, USA.
John PhoenixHuntridge Family Clinic, Las Vegas, Nevada, USA.
Islam YounisGilead Sciences, Foster City, California, USA.
Jason HalperinCrescent Care, New Orleans, Louisiana, USA.
Gilead Sciences (United States) · USAmsterdam University Medical Centers · NLClinical Research Center of Nevada · USGGD Amsterdam · NLIcahn School of Medicine at Mount Sinai · USLouisiana State University Health Sciences Center New Orleans · USRuane Medical · USZentrum für Pathologie und Zytodiagnostik · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: Transgender women are disproportionately affected by HIV and are underutilizing preexposure prophylaxis (PrEP). The lower uptake of PrEP by transgender women may be, in part, owing to the perception that taking PrEP may lower the efficacy of gender-affirming hormone therapy (GAHT) or to provider concerns that GAHT may lower the efficacy of PrEP. Methods: DISCOVER was a randomized, double-blind, noninferiority trial comparing emtricitabine (FTC, F) and tenofovir alafenamide (F/TAF) versus emtricitabine and tenofovir disoproxil fumarate (F/TDF) as PrEP among transgender women and cisgender men who have sex with men (MSM). This nested substudy of the DISCOVER trial compared the exposure of the active intracellular metabolites of FTC and tenofovir (TFV), FTC triphosphate (FTC-TP) and TFV diphosphate (TFV-DP), in peripheral blood mononuclear cells (PBMC) among transgender women receiving GAHT versus MSM within the F/TAF and F/TDF groups. Results: Our results demonstrate that TFV-DP and FTC-TP levels in PBMC were comparable between transgender women on GAHT and MSM receiving F/TAF, and between transgender women on GAHT and MSM receiving F/TDF. TFV-DP concentrations remained above the EC Conclusions: These findings are consistent with the clinical pharmacology of GAHT, FTC, TDF, and TAF reported in previous studies, and support the continued use of F/TAF and F/TDF for PrEP in transgender women. Clinicaltrials.gov registration number: NCT02842086.

Indexed as

DISCOVER trialdrug–drug interactiongender affirming hormonespreexposure prophylaxistransgender women

Identifiers

PMID38312459
PMCPMC10835152
OpenAlexW4296777441

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.