Evidence map›Paper›PMID 34310204›Full record

ArticleAntimicrobial agents and chemotherapy2021

Plasma and Breast Milk Pharmacokinetics of Tenofovir Disoproxil Fumarate in Nursing Mother with Chronic Hepatitis B-Infant Pairs.

U S Erturk, B Mete, R Ozaras, N Saltoglu, I I Balkan, A Mert, B Kacmaz, O Saglam, B Guney, O A Sayman and 1 more

Open access · greenAbstract read
In one paragraph

Article in Antimicrobial agents and chemotherapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
0.8field-weighted citation impact, top 25% 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

10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 14 citations in OpenAlex.

  1. Pooled it
  2. [Chinese practice guidelines for the prevention and treatment of mother-to-child transmission of hepatitis B virus (version 2024)].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2024
    Guideline
  3. Article
  4. Article
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  8. Review
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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

11 authors at 3 institutions in 1 country.

U S ErturkIstanbul University-Cerrahpasa, Cerrahpasa School of Medicine, Department of Infectious Diseases and Clinical Microbiology, Istanbul, Turkey.ORCID 0000-0001-6493-197X
B MeteIstanbul University-Cerrahpasa, Cerrahpasa School of Medicine, Department of Infectious Diseases and Clinical Microbiology, Istanbul, Turkey.
R OzarasMedilife Health Group, Department of Infectious Diseases, Istanbul, Turkey.
N SaltogluIstanbul University-Cerrahpasa, Cerrahpasa School of Medicine, Department of Infectious Diseases and Clinical Microbiology, Istanbul, Turkey.
I I BalkanIstanbul University-Cerrahpasa, Cerrahpasa School of Medicine, Department of Infectious Diseases and Clinical Microbiology, Istanbul, Turkey.
A MertIstanbul Medipol University, Department of Infectious Diseases and Clinical Microbiology, Istanbul, Turkey.
B KacmazAmerican Hospital, Department of Infectious Diseases and Clinical Microbiology, Istanbul, Turkey.
O SaglamNovagenix Bioanalytical Drug R&D Center, Ankara, Turkey.
B GuneyNovagenix Bioanalytical Drug R&D Center, Ankara, Turkey.
O A SaymanIstanbul University-Cerrahpasa, Cerrahpasa School of Medicine, Department of Public Health, Istanbul, Turkey.
F TabakIstanbul University-Cerrahpasa, Cerrahpasa School of Medicine, Department of Infectious Diseases and Clinical Microbiology, Istanbul, Turkey.
Istanbul University-Cerrahpaşa · TRAmerikan Hastanesi · TRIstanbul Medipol University · TR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Tenofovir use is associated with lower risk of mother-to-infant transmission of the virus, and discontinuation of the treatment is not safe. However, the safety of the drug during pregnancy and breastfeeding is not clear. In this study, we aimed to determine the tenofovir concentration in plasma of mother-infant pairs along with breast milk in chronic hepatitis B patients during the lactation period. A total of 11 mother-infant pairs were enrolled in the study. All the mothers received tenofovir disoproxil fumarate (TDF) 245 mg/day for at least 1 month because of chronic hepatitis B infection. Maternal blood, breast milk, and infant blood samples were obtained concomitantly. Tenofovir concentrations were determined by liquid chromatography-tandem mass spectrometry. The median concentrations of tenofovir in maternal plasma and breast milk samples were 88.44 (interquartile range [IQR], 62.47 to 116.17) ng/ml and 6.69 (IQR, 4.88 to 7.03) ng/ml, respectively. Tenofovir concentrations were undetectable (<4 ng/ml) in all of the infant plasma samples. The ratio of tenofovir concentration in breast milk to that in maternal plasma was 0.07. Tenofovir disoproxil fumarate passes through the breast milk in a small amount. Infants had no detectable tenofovir level in their plasma. Our study suggests that tenofovir disoproxil fumarate treatment is safe during the breastfeeding period in chronic hepatitis B patients.

Indexed as

Hepatitis B, ChronicPharmaceutical PreparationsAntiviral AgentsFemaleHumansInfantMilk, HumanMothersPregnancyTenofovirViral LoadAntiviral AgentsPharmaceutical PreparationsTenofovirbreast milkchronic hepatitis Binfant plasmatenofovir

Identifiers

PMID34310204
PMCPMC8448110
OpenAlexW3184719925

What OpenQuestion holds

Textmetadata
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.