Evidence map›Paper›PMID 29528944›Full record

ArticleJournal of acquired immune deficiency syndromes (1999)2018

Rilpivirine Plasma and Cervicovaginal Concentrations in Women During Pregnancy and Postpartum.

Ahizechukwu C Eke, Nahida Chakhtoura, Angela Kashuba, Brookie M Best, Craig Sykes, Jiajia Wang, Alice M Stek, Elizabeth Smith, Samantha Calabrese, Edmund V Capparelli and 2 more

Registry-linked trialAbstract read
In one paragraph

Article in Journal of acquired immune deficiency syndromes (1999), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00042289 (Pharmacokinetic Properties of Antiretroviral and Related Drugs During Pregnancy and Postpartum), which is not on this map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
1.2field-weighted citation impact, top 24% 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.

NCT00042289 completednot on this map

Pharmacokinetic Properties of Antiretroviral and Related Drugs During Pregnancy and Postpartum

TypeobservationalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2003 to 2020Enrolled1,578ConditionsHIV InfectionsArmsatazanavir/cobicistat, darunavir/ritonavir dosage #1, darunavir/ritonavir dosage #2, darunavir/ritonavir dosage #3, elvitegravir/cobicistat
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 15 citations in OpenAlex.

  1. Fosamprenavir with Ritonavir Pharmacokinetics during Pregnancy.Antimicrobial agents and chemotherapy · 2020
    Trial
  2. Article
  3. Review
  4. Article
  5. Review
  6. Review
  7. Review
  8. Review
  9. Review
  10. Article
  11. Article
  12. Tenofovir alafenamide use in pregnant and lactating women living with HIV.Expert opinion on drug metabolism & toxicology · 2020
    Review
  13. Darunavir Pharmacokinetics With an Increased Dose During Pregnancy.Journal of acquired immune deficiency syndromes (1999) · 2020
    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

12 authors at 8 institutions in 1 country.

Ahizechukwu C EkeDivision of Maternal/Fetal Medicine & Clinical Pharmacology, Department of Gynecology and Obstetrics, Johns Hopkins University School of Medicine, Baltimore, MD.
Nahida ChakhtouraDivision of Maternal and Pediatric Infectious Disease, Eunice Kennedy Shriver National Institute of Child Health and Development (NICHD) at the National Institutes of Health (NIH), Bethesda, MD.
Angela KashubaDepartment of Clinical Pharmacology and Analytical Chemistry, Eshelman School of Pharmacy, University of North Carolina, Chapel Hill, NC.
Brookie M BestDepartment of Clinical Pharmacy and Pediatrics, University of California San Diego, San Diego, CA.
Craig Sykes
Jiajia WangDepartment of Biostatistics, Harvard School of Public Health, Boston, MA.
Alice M StekDepartment of Obstetrics and Gynecology, University of Southern California, Los Angeles, CA.
Elizabeth SmithDivision of AIDS National Institute of Allergy and Infectious Diseases (NIAID), Bethesda, MD.
Samantha CalabreseDivision of Maternal and Pediatric Infectious Disease, Eunice Kennedy Shriver National Institute of Child Health and Development (NICHD) at the National Institutes of Health (NIH), Bethesda, MD.
Edmund V CapparelliDepartment of Clinical Pharmacology, University of California San Diego, San Diego, CA.
Mark MirochnickDepartment of Pediatrics, Boston University, Boston, MA.
IMPAACT P1026s Protocol Team
Eunice Kennedy Shriver National Institute of Child Health and Human Development · USUniversity of California, San Diego · USUniversity of North Carolina at Chapel Hill · USAIDS United · USBoston University · USHarvard University · USJohns Hopkins Medicine · 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 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
Virology, Immunology, and Microbiology CoreP30AI050410 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAVID M. MARGOLIS · 2001 to 2026
$76.9M
LC - IMPAACT Leadership GroupUM1AI106716 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$47.2M
Statistical and Data Management Center-Pediatric,Adolescent, and Maternal CTGU01AI068616 · NIAID · HARVARD SCHOOL OF PUBLIC HEALTH · PI SHAPIRO, DAVID ERIC · 2006 to 2010
$38.6M
Clinical Pharmacology Training ProgramT32GM066691 · NIGMS · JOHNS HOPKINS UNIVERSITY · PI Matthew Michael Ippolito · 2003 to 2026
$6.4M
NIAID NIH HHS P30 AI050410NIAID NIH HHS U01 AI068616NIAID NIH HHS UM1 AI068616NIAID NIH HHS UM1 AI068632NIAID NIH HHS UM1 AI106716NIGMS NIH HHS T32 GM066691
6 · The paper itself

Abstract

backgroundConcentrations of antiretrovirals in the genital tract play a key role in preexposure prophylaxis. This study aims to describe rilpivirine (Edurant) concentrations in the genital tract in pregnant and postpartum women.

methodsInternational Maternal Pediatric Adolescent AIDS Clinical Trials Protocol P1026s is an ongoing, prospective study of antiretroviral pharmacokinetics in HIV-infected pregnant women that include a cohort receiving rilpivirine combination regimen. Intensive pharmacokinetics evaluations were performed at steady state during the second and third trimester, and postpartum. Plasma and directly aspirated cervicovaginal fluid (CVF) samples were collected at 4 time points around an observed dose and measured using high-performance liquid chromatography with ultraviolet detection, [plasma; lower limit of quantification (LLQ) = 10 ng/mL] or liquid chromatography-tandem mass spectrometry (CVF; LLQ = 1 ng/mL).

resultsA total of 24 women were included in the analysis. For all time points combined, median (interquartile range) rilpivirine concentrations were 70 ng/mL (23-121) in CVF and 92 ng/mL (49-147) in plasma. The CVF to plasma AUC(0-4) ratios were significantly higher in the second (0.90, 90% CI: 0.61 to 1.46) and third trimesters of pregnancy compared with postpartum (0.40, 90% CI: 0.19 to 0.87). Three of 189 (1.6%) plasma samples in 2 women were below the LLQ and the corresponding CVF concentrations. Seventeen additional CVF concentrations (10.6%) were below LLQ in 13 participants. No major safety concerns were noted.

conclusionsRilpivirine concentrations were higher in the CVF during pregnancy compared with postpartum. CVF Rilpivirine is likely to achieve inhibitory concentrations effective for preventing peripartum HIV transmission.

Indexed as

Postpartum PeriodAdolescentAnti-HIV AgentsCervix UteriFemaleHIV InfectionsHumansPregnancyPregnancy Complications, InfectiousRilpivirineVaginaYoung AdultAnti-HIV AgentsRilpivirine

Identifiers

PMID29528944
PMCPMC6002878
OpenAlexW2791440146

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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.