Evidence map›Paper›PMID 30570527›Full record

ArticleJournal of acquired immune deficiency syndromes (1999)2019

Antiretroviral Drug Concentrations in Breastmilk, Maternal HIV Viral Load, and HIV Transmission to the Infant: Results From the BAN Study.

Nicole L Davis, Amanda Corbett, Josh Kaullen, Julie A E Nelson, Charles S Chasela, Dorothy Sichali, Michael G Hudgens, William C Miller, Denise J Jamieson, Athena P Kourtis

Registry-linked trialAbstract read
In one paragraph

Article in Journal of acquired immune deficiency syndromes (1999), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04862975 (Pharmacokinetics of Antiretroviral Drugs in Lactating Women and Breastmilk Fed Infants Under 6 Months of Age in Botswana), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
–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.

NCT04862975 completednot on this mapstarted 2024, after this paper: background citation

Pharmacokinetics of Antiretroviral Drugs in Lactating Women and Breastmilk Fed Infants Under 6 Months of Age in Botswana

TypeobservationalSponsorDuke UniversityRan2024 to 2025Enrolled164ConditionsLactating Women on Select DOI, Breastmilk Fed Infants of Mothers on Select DOI, HIV InfectionsArmsDolutegravir, Lamivudine, Emtricitabine, Tenofovir Disoproxil Fumarate
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Article
  4. Article
  5. Review
  6. Review
  7. 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

10 authors.

Nicole L DavisDivision of Reproductive Health, Centers for Disease Control and Prevention, Atlanta, GA.
Amanda CorbettDivision of Pharmacotherapy and Experimental Therapeutics, Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC.
Josh KaullenDivision of Pharmacotherapy and Experimental Therapeutics, Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC.
Julie A E NelsonDepartment of Medicine, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC.
Charles S ChaselaDivision of Epidemiology and Biostatistics, School of Public Health, University of Witwatersrand, Parktown, South Africa.
Dorothy SichaliUNC Project Malawi, Lilongwe, Malawi.
Michael G HudgensDepartment of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC.
William C MillerDepartment of Epidemiology, Ohio State University, Columbus, OH.
Denise J JamiesonDivision of Reproductive Health, Centers for Disease Control and Prevention, Atlanta, GA.
Athena P KourtisDivision of Reproductive Health, Centers for Disease Control and Prevention, Atlanta, GA.

Funding

International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) GroupU01AI068632 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI JACKSON, J BROOKS · 2006 to 2010
$109.7M
Virology, Immunology, and Microbiology CoreP30AI050410 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAVID M. MARGOLIS · 2001 to 2026
$76.9M
Fogarty International Clinical Research Scholars Support Center @ Vanderbilt-AAMCR24TW007988 · FIC · VANDERBILT UNIVERSITY · PI VERMUND, STEN H. · 2007 to 2011
$27.6M
UNC Center for Health Promotion and Disease PreventionU48DP000059 · DP · UNIV OF NORTH CAROLINA CHAPEL HILL · PI AMMERMAN, ALICE S · 2004 to 2009
$14.4M
AIDS INTERNATIONAL TRAINING AND RESEARCH PROGRAMD43TW001039 · FIC · UNIV OF NORTH CAROLINA CHAPEL HILL · PI ADIMORA, ADAORA A · 1998 to 2013
$9.9M
Training in Infectious Disease Epidemiology (TIDE)T32AI070114 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Brian W Pence · 2007 to 2026
$4.0M
Breastmilk Transmission of HIV: Virology, Pharmacokinetics, and Adherence in BANR56AI091547 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI FISCUS, SUSAN A. · 2010 to 2010
$619k
Effects of Daily Cotrimoxazole on Malaria in HIV Exposed, Uninfected InfantsR03AI100694 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI JULIANO, JONATHAN J · 2013 to 2014
$152k
ACL HHS U48DP001944FIC NIH HHS D43 TW001039FIC NIH HHS R24 TW007988Intramural CDC HHS CC999999NCCDPHP CDC HHS U48 DP000059NIAID NIH HHS P30 AI050410NIAID NIH HHS R03 AI100694NIAID NIH HHS R56 AI091547NIAID NIH HHS T32 AI070114NIAID NIH HHS U01 AI068632
6 · The paper itself

Abstract

backgroundConcentration of antiretroviral (ARV) drug found in plasma, and amounts of drug excreted into breastmilk, may affect HIV viral load and potentially perinatal HIV transmission.

methodsIn this cohort study with 2-phase sampling, we included mothers randomized to postpartum maternal ARVs or daily infant nevirapine during 28 weeks of breastfeeding in the Breastfeeding, Antiretrovirals, and Nutrition study. Among these, we included all mothers who transmitted HIV to their infants between 2 and 28 weeks and 15% of mothers who did not (n = 27 and 227, respectively). Spearman correlation coefficients (r) were used to assess the correlation between maternal plasma and breastmilk ARV concentration. Associations between the median effective drug concentration (EC50) and detectable maternal viral load (plasma: >40 copies per milliliter, breastmilk: >56 copies per milliliter) were assessed using mixed-effects models. Cox models were used to estimate the association between maternal or infant plasma drug concentration and breastmilk HIV transmission from 2 to 28 weeks.

resultsAll ARV compounds exhibited substantial correlations between maternal plasma and breastmilk concentrations (r: 0.85-0.98, P-value <0.0001). Having plasma drug concentration above the EC50 was associated with lower odds of having detectable HIV RNA [maternal plasma odds ratio (OR) 0.64, 95% confidence interval (CI): 0.45 to 0.91; breastmilk OR 0.22, 95% CI: 0.14 to 0.35] and a reduced rate of breastmilk HIV transmission (hazard ratio 0.40, 95% CI: 0.18 to 0.93). Having breastmilk drug concentration above the EC50 was also associated with lower odds of having detectable maternal HIV RNA (plasma OR 0.62, 95% CI: 0.45 to 0.85; breastmilk OR 0.42, 95% CI: 0.29 to 0.59).

conclusionsEnsuring adequate drug concentration is important for viral suppression and preventing breastmilk HIV transmission.

Indexed as

AdolescentAdultAnti-HIV AgentsBreast FeedingFemaleHIV-1HIV InfectionsHumansInfantInfant, NewbornInfectious Disease Transmission, VerticalLamivudineLopinavirMiddle AgedMilk, HumanPregnancyAnti-HIV AgentsLamivudineLopinavirRitonavirRNA, ViralZidovudine

Identifiers

PMID30570527
PMCPMC6391211

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Registered trials

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.