Evidence map›Paper›PMID 29894385›Full record

ArticleAIDS (London, England)2018

Tenofovir and tenofovir-diphosphate concentrations during pregnancy among HIV-uninfected women using oral preexposure prophylaxis.

Maria Pyra, Peter L Anderson, Craig W Hendrix, Renee Heffron, Kenneth Mugwanya, Jessica E Haberer, Katherine K Thomas, Connie Celum, Deborah Donnell, Mark A Marzinke and 6 more

Abstract read
In one paragraph

Article in AIDS (London, England), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers.

0numbers the graph read from it
0cells of the map it votes in
26citing 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

26 citing papers in PubMed.

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  18. Frequency and Predictors of Tenofovir-diphosphate Detection Among Young Kenyan Women in a Real-world Pre-exposure Prophylaxis Implementation Program.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2020
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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.

Maria PyraDepartment of Epidemiology.
Peter L AndersonDepartment of Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, Aurora.
Craig W HendrixDepartment of Medicine (Clinical Pharmacology), Johns Hopkins University, Baltimore.
Renee HeffronDepartment of Epidemiology.
Kenneth MugwanyaDepartment of Global Health.
Jessica E HabererMassachusetts General Hospital Global Health and Harvard Medical School.
Katherine K ThomasDepartment of Global Health.
Connie CelumDepartment of Epidemiology.
Deborah DonnellDepartment of Global Health.
Mark A MarzinkeDepartment of Medicine (Clinical Pharmacology), Johns Hopkins University, Baltimore.
Elizabeth A BukusiDepartment of Global Health.
Nelly R MugoDepartment of Global Health.
Stephen AsiimweKabwohe Clinical Research Center.
Elly KatabiraInfectious Disease Institute, Makerere University, Uganda.
Jared M BaetenDepartment of Epidemiology.
Partners Demonstration Study Team

Funding

SDMC: HPTN 084 Pregnancy SupplementUM1AI068617 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Elizabeth Renata Brown, Deborah J Donnell · 2011 to 2026
$204.9M
University of Washington/Fred Hutch Center for AIDS ResearchP30AI027757 · NIAID · UNIVERSITY OF WASHINGTON · PI EDWIN ROBERTO ORELLANA · 1988 to 2026
$104.9M
LC: HIV Prevention Trials Network - Laboratory Support for the SARS-CoV-2 Seroprevalence Study (CoVPN 5002)UM1AI068613 · NIAID · JOHNS HOPKINS UNIVERSITY · PI SUSAN H ESHLEMAN, Mark A Marzinke · 2011 to 2026
$100.2M
NRSA Training CoreTL1TR002318 · NCATS · UNIVERSITY OF WASHINGTON · PI Megan Moore · 2017 to 2026
$8.4M
Optimizing Antiretroviral-Based HIV Prevention for HIV Serodiscordant CouplesR01MH095507 · NIMH · UNIVERSITY OF WASHINGTON · PI BAETEN, JARED · 2011 to 2020
$6.1M
A differentiated care model to improve the efficiency of PrEP delivery in KenyaK99MH118134 · NIMH · UNIVERSITY OF WASHINGTON · PI MUGWANYA, KENNETH KIGGUNDU · 2018 to 2018
$123k
NCATS NIH HHS TL1 TR002318NIAID NIH HHS P30 AI027757NIAID NIH HHS UM1 AI068613NIAID NIH HHS UM1 AI068617NIMH NIH HHS K99 MH118134NIMH NIH HHS R01 MH095507
6 · The paper itself

Abstract

objectivesPregnancy is a time of increased HIV acquisition risk and pregnancy reduces concentrations of antiretrovirals used for treatment. We assessed whether pregnancy lowers concentrations of tenofovir (TFV) and tenofovir-diphosphate (TFV-DP) among HIV-uninfected women using oral preexposure prophylaxis (PrEP).

methodsWe analyzed data from an open-label PrEP study, comparing concentrations of TFV in plasma and TFV-DP in dried blood spots (DBS) among 37 pregnant women and 97 nonpregnant women. Analyses controlled for adherence from daily electronic monitoring.

resultsThe average plasma concentration of TFV among pregnant women was 34.7 ng/ml with 22.2 average recorded doses over the prior month versus 86.5 ng/ml with 23.1 doses among nonpregnant women. After controlling for adherence, TFV concentrations were 58% lower among pregnant women, a statistically significant difference of -50.4 ng/ml (95% CI -68.3 to -32.5). The average TFV-DP concentration was 450.3 fmol/punch among pregnant women and 636.7 fmol/punch among nonpregnant women. This difference was not statistically significant after adjusting for adherence; however, among those with quantifiable TFV-DP, concentrations were 27% lower during pregnancy [-202 fmol/punch (95% CI -384 to -19)]. Among participants with samples before and during pregnancy, there were significant decreases during pregnancy, controlling for adherence: -28.1 ng/ml TFV (95% CI -52.3 to -4.0) and -289.2 fmol/punch TFV-DP (95% CI -439.0 to -139.3).

conclusionConsistent with studies among HIV-infected women on ART, we found TFV and TFV-DP concentrations were lower during pregnancy. There is no established TFV concentration threshold to achieve HIV prevention. Additional pharmacokinetic studies and studies of PrEP efficacy in pregnancy are needed.

Indexed as

Blood Chemical AnalysisAdenineAdministration, OralAdultAnti-HIV AgentsChemopreventionFemaleHIV InfectionsHumansMiddle AgedOrganophosphatesPre-Exposure ProphylaxisPregnancyPregnancy Complications, InfectiousYoung AdultAdenineAnti-HIV AgentsOrganophosphatestenofovir diphosphate

Identifiers

PMID29894385
PMCPMC6061961

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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.