Evidence map›Paper›PMID 40968165›Full record

ArticleScientific reports2025

Breastfeeding on ART and a closer look at drug transfer to HIV-exposed uninfected infants.

Benedikt D Spielberger, Alicia Zink, Jan C Rohr, Susanne Usadel, Hartwig Klinker, Mirjam Freudenhammer, Roland Elling, Siegbert Rieg, Philipp Henneke, Markus Hufnagel and 1 more

Abstract read
In one paragraph

Article in Scientific reports, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

11 authors.

Benedikt D Spielberger *Division of Pediatric Infectious Diseases and Rheumatology, Department of Pediatrics and Adolescent Medicine, Faculty of Medicine, University Medical Center, University of Freiburg, Freiburg, Germany. Benedikt.spielberger@uniklinik-freiburg.de.
Alicia Zink *Division of Pediatric Infectious Diseases and Rheumatology, Department of Pediatrics and Adolescent Medicine, Faculty of Medicine, University Medical Center, University of Freiburg, Freiburg, Germany. Alicia.zink@uniklinik-freiburg.de.
Jan C RohrDivision of Pediatric Infectious Diseases and Rheumatology, Department of Pediatrics and Adolescent Medicine, Faculty of Medicine, University Medical Center, University of Freiburg, Freiburg, Germany.
Susanne UsadelDepartment of Infection Medicine, Medical Service Centre Clotten, Freiburg, Germany.
Hartwig KlinkerDivision of Infectious Diseases, Department of Internal Medicine II, University of Würzburg Medical Center, Würzburg, Germany.
Mirjam FreudenhammerDivision of Pediatric Infectious Diseases and Rheumatology, Department of Pediatrics and Adolescent Medicine, Faculty of Medicine, University Medical Center, University of Freiburg, Freiburg, Germany.
Roland EllingDivision of Pediatric Infectious Diseases and Rheumatology, Department of Pediatrics and Adolescent Medicine, Faculty of Medicine, University Medical Center, University of Freiburg, Freiburg, Germany.
Siegbert RiegDepartment of Medicine II (Gastroenterology, Hepatology, Endocrinology and Infectious Diseases), Faculty of Medicine, University Medical Center, University of Freiburg, Freiburg, Germany.
Philipp HennekeDivision of Pediatric Infectious Diseases and Rheumatology, Department of Pediatrics and Adolescent Medicine, Faculty of Medicine, University Medical Center, University of Freiburg, Freiburg, Germany.
Markus HufnagelDivision of Pediatric Infectious Diseases and Rheumatology, Department of Pediatrics and Adolescent Medicine, Faculty of Medicine, University Medical Center, University of Freiburg, Freiburg, Germany.
Matthias C MüllerDepartment of Infection Medicine, Medical Service Centre Clotten, Freiburg, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Adherence to antiretroviral therapy (ART) and maintaining an undetectable maternal HIV viral load effectively prevent intrauterine and perinatal HIV transmission 1, 2. However, concerns remain regarding the safety of breastfeeding in infants exposed to maternal ART. This retrospective study analyzed eight breastfed HIV-exposed uninfected (HEU) infants who were followed from January 2015 to July 2022. Maternal ART regimens included abacavir/lamivudine (n = 2), tenofovir alafenamide/emtricitabine (n = 1) or tenofovirdisoproxil/emtricitabine (n = 5) in combinations with rilpivirine (n = 3) (RPV), dolutegravir (n = 2) (DTG), raltegravir (n = 1), darunavir/ritonavir (n = 1), or nevirapine (n = 1). Infants and mothers underwent sequential HIV-PCR testing, complete blood count, and ART drug monitoring in breast milk, infant serum, and maternal serum when available. The relative infant dose (RID) was calculated to assess drug exposure. Hematological parameters were compared with those of 62 HEU formula-fed infants from the same institution. No HIV transmission occurred. ART serum levels in breastfed infants varied significantly, with RPV and DTG levels above the adult target range in two cases. Notably, one infant had RPV levels exceeding the target RID by 633%, leading to cessation of breastfeeding. At four months, mean absolute neutrophil counts were lower in breastfed infants (1,130/µl) compared to formula-fed infants (2,000/µl), with the lowest individual absolute neutrophil counts in the formula-fed group. Despite ART levels above the adult target range in 3 infants, there was no consistent pattern between neutropenia and elevated ART levels. Our findings highlight the substantial variability in infant ART exposure during breastfeeding. Given this variability and the potential for drug accumulation in individual cases, maternal therapeutic drug monitoring should be considered to identify elevated levels early on. In such situations, infant monitoring tailored to the individual may also be warranted.

Indexed as

Anti-HIV AgentsAnti-Retroviral AgentsBreast FeedingHIV InfectionsInfectious Disease Transmission, VerticalAdultFemaleHumansInfantInfant, NewbornMaleMilk, HumanPregnancyPregnancy Complications, InfectiousRetrospective StudiesViral LoadAnti-HIV AgentsAnti-Retroviral AgentsBreastfeedingHIV-exposedHIV-exposed uninfected (HEU)Maternal ARTNeutropenia

Identifiers

PMID40968165
PMCPMC12446422

What OpenQuestion holds

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Registered trials

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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.