Evidence map›Paper›PMID 32960984›Full record

ArticleJournal of clinical pharmacology2021

Effect of Pregnancy and Concomitant Antiretrovirals on the Pharmacokinetics of Tenofovir in Women With HIV Receiving Tenofovir Disoproxil Fumarate-Based Antiretroviral Therapy Versus Women With HBV Receiving Tenofovir Disoproxil Fumarate Monotherapy.

Vera E Bukkems, Elise J Smolders, Gonzague Jourdain, David M Burger, Angela P Colbers, Tim R Cressey, PANNA Network and iTAP Study Group

Open access · hybridAbstract readComparative Study
In one paragraph

Article in Journal of clinical pharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.1field-weighted citation impact, top 41% 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

5 citing papers in PubMed, 8 citations in OpenAlex.

  1. Article
  2. Observational
  3. Review
  4. Review
  5. Review
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

7 authors at 3 institutions in 5 countries.

Vera E BukkemsDepartment of Pharmacy, Radboud Institute of Health Sciences (RIHS), Radboud University Medical Center, Nijmegen, The Netherlands.ORCID 0000-0002-7644-1123
Elise J SmoldersDepartment of Pharmacy, Radboud Institute of Health Sciences (RIHS), Radboud University Medical Center, Nijmegen, The Netherlands.
Gonzague JourdainFrench National Research Institute for Sustainable Development (IRD), Marseille, France.
David M BurgerDepartment of Pharmacy, Radboud Institute of Health Sciences (RIHS), Radboud University Medical Center, Nijmegen, The Netherlands.
Angela P ColbersDepartment of Pharmacy, Radboud Institute of Health Sciences (RIHS), Radboud University Medical Center, Nijmegen, The Netherlands.
Tim R CresseyFrench National Research Institute for Sustainable Development (IRD), Marseille, France.ORCID 0000-0002-8106-0974
PANNA Network and iTAP Study GroupDepartment of Pharmacy, Radboud Institute of Health Sciences (RIHS), Radboud University Medical Center, Nijmegen, The Netherlands.
Radboud University Nijmegen · NLInstitute for Sustainable Development · ETUniversity of Liverpool · GB

Funding

Antiviral prophylaxis to prevent perinatal transmission of HBV in ThailandU01HD071889 · NICHD · INSTITUTE OF RESEARCH AND DEVELOPMENT · PI JOURDAIN, GONZAGUE JOSEPH · 2012 to 2016
$2.0M
NICHD NIH HHS U01 HD071889
6 · The paper itself

Abstract

Tenofovir disoproxil fumarate (TDF) is recommended as part of antiretroviral therapy (ART) for pregnant women with HIV and as monotherapy for pregnant women with hepatitis B virus (HBV) monoinfection at high risk of transmitting infection to their infants. Tenofovir (TFV) plasma exposures are reduced during pregnancy; however, concomitant antiretrovirals and the viral infection itself can also influence TFV pharmacokinetics. Our aim was to compare TFV pharmacokinetics in pregnant women receiving TDF-based ART, with or without a ritonavir-boosted protease inhibitor (r/PI), to pregnant women with HBV receiving TDF monotherapy. Non-r/PI regimens were primarily integrase strand transfer inhibitors or nonnucleoside reverse transcriptase inhibitor-based regimens. Data were combined from a pharmacokinetic study of pregnant women with HIV on ART (PANNA), and a study assessing TFV pharmacokinetics in pregnant women with HBV (iTAP). A total of 196 pregnant women, 59 with HIV (32 receiving r/PIs) and 137 with HBV monoinfection were included. Intraindividual TFV area under the plasma concentration-time curve from time 0 to 24 hours was 25%, 26%, and 21% lower during the third trimester compared to 1 month postpartum in women with HIV using TDF and an r/PI or TDF and non-r/PI and women with HBV receiving TDF monotherapy, respectively. TFV area under the plasma concentration-time curve from time 0 to 24 hours was similar in pregnant women receiving non-r/PI to pregnant women with HBV receiving TDF monotherapy (1.84 vs 1.86 µg • h/mL); however, pregnant women receiving TDF with an r/PI had higher exposures (2.41 µg • h/mL; P < .01). Pregnancy reduces TFV exposure and the relative size was not impacted by concomitant antiretroviral drugs or viral infection, but a drug-drug interaction between TDF and r/PI remains during pregnancy, leading to higher exposures than those on TDF and non-r/PI or TDF monotherapy.

Indexed as

AdultAnti-HIV AgentsArea Under CurveDrug InteractionsFemaleHepatitis BHIV InfectionsHumansInfectious Disease Transmission, VerticalPostpartum PeriodPregnancyPregnancy Complications, InfectiousRandomized Controlled Trials as TopicRetrospective StudiesReverse Transcriptase InhibitorsTenofovirAnti-HIV AgentsReverse Transcriptase InhibitorsTenofovirantiretroviral therapyhepatitisHIVpregnancytenofovir disoproxil fumarate

Identifiers

PMID32960984
PMCPMC7891399
OpenAlexW3088630931

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.