Evidence map›Paper›PMID 24637511›Full record

ArticlePloS one2014

Daily oral emtricitabine/tenofovir preexposure prophylaxis and herpes simplex virus type 2 among men who have sex with men.

Julia L Marcus, David V Glidden, Vanessa McMahan, Javier R Lama, Kenneth H Mayer, Albert Y Liu, Orlando Montoya-Herrera, Martin Casapia, Brenda Hoagland, Robert M Grant

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 3 pooled it
2.4field-weighted citation impact, top 12% 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.

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

17 citing papers in PubMed, 3 syntheses or guidelines pooled it, 31 citations in OpenAlex.

  1. Sexually Transmitted Infections Treatment Guidelines, 2021.MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2021
    Guideline
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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

10 authors at 9 institutions in 4 countries.

Julia L MarcusGladstone Institute of Virology and Immunology, San Francisco, California, United States or America; University of California, Berkeley, California, United States of America.
David V GliddenUniversity of California San Francisco, San Francisco, California, United States of America.
Vanessa McMahanGladstone Institute of Virology and Immunology, San Francisco, California, United States or America.
Javier R LamaAsociación Civil Impacta Salud y Educación, Lima, Peru.
Kenneth H MayerFenway Institute, Fenway Health, Boston, Massachusetts, United States of America; Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States of America.
Albert Y LiuBridge HIV, San Francisco Department of Public Health, San Francisco, California, United States of America.
Orlando Montoya-HerreraFundación Ecuatoriana Equidad, Guayaquil, Guayas, Ecuador.
Martin CasapiaAsociación Civil Selva Amazónica, Iquitos, Peru.
Brenda HoaglandInstituto de Pesquisa Clínica Evandro Chagas, Fundação Oswaldo Cruz, Rio de Janeiro, Brazil.
Robert M GrantGladstone Institute of Virology and Immunology, San Francisco, California, United States or America; University of California San Francisco, San Francisco, California, United States of America.
Gladstone Institutes · USAsociación Civil Impacta Salud y Educación · PEAsociación para la Conservación de la Cuenca Amazónica · PEFenway Health · USFundação Oswaldo Cruz · BRInstituto Ecuatoriano de Enfermedades Digestivas · ECSan Francisco Department of Public Health · USUniversity of California, Berkeley · USUniversity of California, San Francisco · US

Funding

Virology CoreP30AI027763 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI STEVEN Grant DEEKS · 1988 to 2026
$93.6M
Chemoprophylaxis for HIV Prevention in Men SupplementU01AI064002 · NIAID · J. DAVID GLADSTONE INSTITUTES · PI GRANT, ROBERT M. · 2005 to 2011
$41.3M
NIAID NIH HHS P30 AI027763NIAID NIH HHS U01 AI064002NIAID NIH HHS U01 AI64002
6 · The paper itself

Abstract

backgroundIn addition to protecting against HIV acquisition, antiretroviral preexposure prophylaxis (PrEP) using topical 1% tenofovir gel reduced Herpes simplex virus type 2 (HSV-2) acquisition by 51% among women in the CAPRISA 004 study. We examined the effect of daily oral emtricitabine/tenofovir (FTC/TDF) PrEP on HSV-2 seroincidence and ulcer occurrence among men who have sex with men (MSM) in the iPrEx trial.

methodsHSV-2 serum testing was performed at screening and every six months. Among HSV-2-seronegative individuals, we used Cox regression models to estimate hazard ratios (HRs) of HSV-2 seroincidence associated with randomization to FTC/TDF. We used multiple imputation and Cox regression to estimate HRs for HSV-2 seroincidence accounting for drug exposure. We assessed ulcer occurrence among participants with prevalent or incident HSV-2 infection.

resultsOf the 2,499 participants, 1383 (55.3%) tested HSV-2-seronegative at baseline, 892 (35.7%) tested positive, 223 (8.9%) had indeterminate tests, and one test was not done. Of the 1,347 HSV-2-seronegative participants with follow-up, 125 (9.3%) had incident HSV-2 infection (5.9 per 100 person-years). Compared with participants receiving placebo, there was no difference in HSV-2 seroincidence among participants receiving FTC/TDF (HR 1.1, 95% CI: 0.8-1.5; P = 0.64) or among participants receiving FTC/TDF with a concentration of tenofovir diphosphate >16 per million viable cells (HR 1.0, 95% CI: 0.3-3.5; P = 0.95). Among participants with HSV-2 infection, the proportion with ≥1 moderate or severe ulcer adverse event was twice as high in the placebo vs. active arm (5.9% vs. 2.9%, P = 0.02), but there were no differences in the proportions with ≥1 clinical examination during which perianal or groin ulcers were identified.

conclusionsTenofovir in daily oral FTC/TDF PrEP may reduce the occurrence of ulcers in individuals with HSV-2 infection but does not protect against HSV-2 incidence among MSM.

Indexed as

ChemopreventionHomosexuality, MaleAdenineAdolescentAdultAgedAntiviral AgentsDeoxycytidineEmtricitabineHerpes SimplexHerpesvirus 2, HumanHumansIncidenceMaleMiddle AgedOrganophosphonatesAdenineAntiviral AgentsDeoxycytidineEmtricitabineOrganophosphonatesTenofovir

Identifiers

PMID24637511
PMCPMC3956614
OpenAlexW2032435799

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.