Evidence map›Paper›PMID 34254323›Full record

ArticleJournal of clinical pharmacy and therapeutics2021

Lopinavir and tenofovir interaction observed in non-pregnant adults altered during pregnancy.

Nikki Mulligan, Engie Salama, Jeremiah D Momper, Edmund V Capparelli, Alice Stek, Nahida Chakhtoura, Mark Mirochnick, Brookie M Best, IMPAACT P1026s Protocol Team

Open access · greenAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of clinical pharmacy and therapeutics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.2field-weighted citation impact, top 46% 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

2 citing papers in PubMed, 5 citations in OpenAlex.

  1. Review
  2. 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

9 authors at 5 institutions in 1 country.

Nikki MulliganRiverside University Health System, Moreno Valley, CA, USA.
Engie SalamaSkaggs School of Pharmacy and Pharmaceutical Sciences, University of California, San Diego, CA, USA.ORCID https://orcid.org/0000-0002-7009-3666
Jeremiah D MomperSkaggs School of Pharmacy and Pharmaceutical Sciences, University of California, San Diego, CA, USA.
Edmund V CapparelliSkaggs School of Pharmacy and Pharmaceutical Sciences, University of California, San Diego, CA, USA.
Alice StekUniversity of Southern California School of Medicine, Los Angeles, CA, USA.
Nahida ChakhtouraMaternal and Pediatric Infectious Disease Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Bethesda, MD, USA.
Mark MirochnickBoston University School of Medicine, Boston, MA, USA.
Brookie M BestSkaggs School of Pharmacy and Pharmaceutical Sciences, University of California, San Diego, CA, USA.
IMPAACT P1026s Protocol Team
University of California San Diego · USBoston University · USEunice Kennedy Shriver National Institute of Child Health and Human Development · USRiverside University Health System - Medical Center · USUniversity of Southern California · US

Funding

LOC-IMPAACT Leadership GroupPharmacokinetics and Safety of Remdesivir for Treatment of COVID-19 in Pregnant Women in the USUM1AI068632 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI Jennifer Jao, Sharon A Nachman · 2011 to 2026
$278.1M
Statistical and Data Management Center-Pediatric,Adolescent, and Maternal CTGUM1AI068616 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Sean Scott Brummel, Marlene Ann Cooper · 2011 to 2026
$155.6M
LC - IMPAACT Leadership GroupUM1AI106716 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$47.2M
University of California, San Diego Clinical Trial UnitUM1AI069536 · NIAID · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI STEPHEN A SPECTOR · 2012 to 2026
$34.0M
National Institute of Allergy and Infectious Diseases UM1AI068616National Institute of Allergy and Infectious Diseases UM1AI068632National Institute of Allergy and Infectious Diseases UM1AI106716NIAID NIH HHS UM1 AI068616NIAID NIH HHS UM1 AI068632NIAID NIH HHS UM1 AI069536NIAID NIH HHS UM1 AI106716NICHD NIH HHS HHSN275201800001CNICHD NIH HHS HHSN275201800001I
6 · The paper itself

Abstract

WHAT IS KNOWN AND

objectiveTenofovir exposure is increased in non-pregnant adults when tenofovir disoproxil fumarate is coadministered with lopinavir/ritonavir. In pregnant women, tenofovir exposure is decreased. Our objective is to describe the effect of lopinavir/ritonavir on tenofovir pharmacokinetics during pregnancy.

methodsData were collected through the International Maternal Pediatric and Adolescent AIDS Clinical Trials (IMPAACT) Network P1026s protocol. This was a nonrandomized, open-label, parallel-group and multicentre phase-IV prospective study in pregnant women with HIV. Intensive steady-state 24-h pharmacokinetic profiles were collected during the third trimester of pregnancy and postpartum. Tenofovir was measured in plasma using validated liquid chromatography-mass spectrometry method (quantification limit: 10 ng/ml). Statistical tests compared paired and between group pharmacokinetic data. RESULTS AND DISCUSSION: In women not receiving lopinavir/ritonavir (n = 28), tenofovir AUC WHAT IS NEW AND

conclusionTenofovir exposure during the third trimester was reduced compared to postpartum in pregnant women not receiving lopinavir/ritonavir, but not in pregnant women also receiving lopinavir/ritonavir. Our findings suggest that pregnancy confounds the expected decrease in tenofovir exposure with concomitant lopinavir/ritonavir in non-pregnant adults. These findings illustrate the need for drug-drug interaction studies in pregnant women as drug disposition differs significantly in pregnant women compared to non-pregnant adults.

Indexed as

AdolescentAdultAnti-HIV AgentsArea Under CurveDrug CombinationsDrug InteractionsFemaleHalf-LifeHumansLopinavirMetabolic Clearance RateMiddle AgedPregnancyProspective StudiesRitonavirTenofovirAnti-HIV AgentsDrug CombinationsLopinavirlopinavir-ritonavir drug combinationRitonavirTenofovirdrug-drug interactiondrug transportersHIV infectionkaletrakidneylopinavirmother-to-child transmissionnucleoside reverse transcriptase inhibitorperinatal transmissionpharmacokineticspregnancytenofovirTruvada™Viread™

Identifiers

PMID34254323
PMCPMC8448937
OpenAlexW3179912192

What OpenQuestion holds

Textmetadata
LicenceTDM
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.