Evidence map›Paper›PMID 30315206›Full record

Trial reportScientific reports2018

Daily HIV pre-exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate-emtricitabine reduced Streptococcus and increased Erysipelotrichaceae in rectal microbiota.

Michael P Dubé, Sung Yong Park, Heather Ross, Tanzy M T Love, Sheldon R Morris, Ha Youn Lee

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Scientific reports, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06005298 (Alcohol Misuse, Gut Microbial Dysbiosis and PrEP Care Continuum), which is not on this map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
2.0field-weighted citation impact, top 13% 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.

NCT06005298 narecruitingnot on this mapstarted 2023, after this paper: background citation

Alcohol Misuse, Gut Microbial Dysbiosis and PrEP Care Continuum: Application and Efficacy of SBIRT Intervention (SEAL)

TypeinterventionalSponsorShirish S BarveRan2023 to 2027Enrolled120ConditionsAlcohol Use Disorder, Risk Behavior, Health, Dysbiosis, HIV InfectionsArmsScreening, Brief Intervention, Referral to Treatment (SBIRT)
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 32 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Review
  9. Article
  10. Article
  11. Osteoporosis and HIV Infection.Calcified tissue international · 2022
    Review
  12. Article
  13. Review
  14. Microbiome Studies in Non-human Primates.Current HIV/AIDS reports · 2021
    Review
  15. Article
  16. Antimicrobial agents and chemotherapy · 2020
    Article
  17. Article
  18. Article
  19. Article
  20. 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

6 authors at 3 institutions in 1 country.

Michael P DubéDepartment of Medicine and Division of Infectious Diseases, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.
Sung Yong ParkDepartment of Molecular Microbiology and Immunology, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.
Heather RossDepartment of Molecular Microbiology and Immunology, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.
Tanzy M T LoveDepartment of Biostatistics and Computational Biology, School of Medicine and Dentistry, University of Rochester, Rochester, NY, USA.
Sheldon R MorrisUniversity of California San Diego Antiviral Research Center, San Diego, CA, USA.
Ha Youn LeeDepartment of Molecular Microbiology and Immunology, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA. hayoun@usc.edu.
University of Southern California · USUniversity of California, San Diego · USUniversity of Rochester · US

Funding

HIV Incidence Assay via Deep Sequencing and Statistical TestsR01AI095066 · NIAID · UNIVERSITY OF SOUTHERN CALIFORNIA · PI LEE, HA YOUN · 2011 to 2025
$8.4M
Simulator for Primary HIV Replication and EvolutionR01AI083115 · NIAID · UNIVERSITY OF SOUTHERN CALIFORNIA · PI LEE, HA YOUN · 2009 to 2017
$3.9M
Division of Intramural Research, National Institute of Allergy and Infectious Diseases (Division of Intramural Research of the NIAID) R01-AI083115NIAID NIH HHS R01 AI083115NIAID NIH HHS R01 AI095066
6 · The paper itself

Abstract

Daily PrEP is highly effective at preventing HIV-1 acquisition, but risks of long-term tenofovir disoproxil fumarate plus emtricitabine (TDF-FTC) include renal decline and bone mineral density decrease in addition to initial gastrointestinal side effects. We investigated the impact of TDF-FTC on the enteric microbiome using rectal swabs collected from healthy MSM before PrEP initiation and after 48 to 72 weeks of adherent PrEP use. The V4 region of the 16S ribosomal RNA gene sequencing showed that Streptococcus was significantly reduced from 12.0% to 1.2% (p = 0.036) and Erysipelotrichaceae family was significantly increased from 0.79% to 3.3% (p = 0.028) after 48-72 weeks of daily PrEP. Catenibacterium mitsuokai, Holdemanella biformis and Turicibacter sanguinis were increased within the Erysipelotrichaceae family and Streptococcus agalactiae, Streptococcus oralis, Streptococcus mitis were reduced. These changes were not associated with host factors including PrEP duration, age, race, tenofovir diphosphate blood level, any drug use and drug abuse, suggesting that the observed microbiome shifts were likely induced by daily PrEP use. Long-term PrEP resulted in increases of Catenibacterium mitsuokai and Holdemanella biformis, which have been associated with gut microbiome dysbiosis. Our observations can aid in characterizing PrEP's side effects, which is likely to improve PrEP adherence, and thus HIV-1 prevention.

Indexed as

Pre-Exposure ProphylaxisAdultBiodiversityDrug Administration ScheduleEmtricitabineErysipelothrixFemaleHIV-1HumansMicrobiotaMiddle AgedRectumSpecies SpecificityStreptococcusTenofovirEmtricitabineTenofovir

Identifiers

PMID30315206
PMCPMC6185988
OpenAlexW2895832102

What OpenQuestion holds

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LicenceCC BY
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.