Evidence map›Paper›PMID 42106326›Full record

ArticleNature communications2026

Pharmacological markers of HIV prevention for oral pre-exposure prophylaxis in men who have sex with men.

Sara Iannuzzi, Malin Müller, Yifan Yu, Lanxin Zhang, Craig W Hendrix, Robert R Bies, Max von Kleist

Erratum issuedAbstract read
In one paragraph

Article in Nature communications, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. 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.

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

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors.

Sara IannuzziProjektgruppen, Robert-Koch Institute Berlin, Berlin, Germany.
Malin MüllerProjektgruppen, Robert-Koch Institute Berlin, Berlin, Germany.ORCID http://orcid.org/0009-0004-3372-6008
Yifan YuDivision of Pharmacokinetics, Pharmacodynamics and Systems Pharmacology, School of Pharmacy and Pharmaceutical Sciences, University at Buffalo, Buffalo, NY, USA.
Lanxin ZhangProjektgruppen, Robert-Koch Institute Berlin, Berlin, Germany.
Craig W HendrixDepartment of Medicine (Clinical Pharmacology) and Pharmacology and Molecular Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA.ORCID http://orcid.org/0000-0002-5696-8665
Robert R BiesDivision of Pharmacokinetics, Pharmacodynamics and Systems Pharmacology, School of Pharmacy and Pharmaceutical Sciences, University at Buffalo, Buffalo, NY, USA.
Max von KleistProjektgruppen, Robert-Koch Institute Berlin, Berlin, Germany. max.kleist@fu-berlin.de.ORCID http://orcid.org/0000-0001-6587-6394

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The human immunodeficiency virus (HIV) infected approximately 1.1 million individuals in 2024. There is no effective vaccine or cure, and funding cuts in resource-limited settings threaten treatment access. Cost-effective and widely available prevention strategies, such as oral emtricitabine/tenofovir disoproxil fumarate pre-exposure prophylaxis (FTC/TDF-PrEP), are therefore essential. Current PrEP guidelines differ between cisgender women and men who have sex with men (MSM), based on mechanistic differences in tissue-level pharmacokinetics (PK) at vaginal vs. colorectal exposure sites. To test these mechanistic hypothesis, we use data from major FTC/TDF-PrEP trials to establish PrEP efficacy when used in MSM. We independently predict efficacy utilizing different PK-matrices in a mechanistic model, simulate each clinical trial informed by adherence data and compare the predictions with clinical efficacy estimates. With this combined approach, two of the five trials (HPTN 083, DISCOVER) yield sufficient statistical power to conclude that rectal tissue pharmacokinetics do not predict PrEP efficacy in MSM. In contrast, PBMC-based predictions agree with clinical PrEP efficacy and support the suitability of on-demand use of oral PrEP in MSM. When combining our findings with recent results on suitable pharmacokinetic markers in women, our work suggests that adherence requirements for cisgender women and MSM may not differ.

Indexed as

Anti-HIV AgentsBiomarkers, PharmacologicalHIV InfectionsHomosexuality, MalePre-Exposure ProphylaxisAdministration, OralAdultEmtricitabineEmtricitabine, Tenofovir Disoproxil Fumarate Drug CombinationFemaleHumansMaleRectumTenofovirAnti-HIV AgentsBiomarkers, PharmacologicalEmtricitabineEmtricitabine, Tenofovir Disoproxil Fumarate Drug CombinationTenofovir

Identifiers

PMID42106326
PMCPMC13157487

What OpenQuestion holds

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Registered trials

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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.