Evidence map›Paper›PMID 42703521›Full record

ArticleOpen forum infectious diseases2026

IMPAACT 2041: Designing the Study of Glecaprevir/Pibrentasvir Treatment During Pregnancy.

Ravi Jhaveri, Kristina M Brooks, Vincent Mainella, John Marcinak, Mong-Jen Chen, Katie McCarthy, Camlin Tierney, Zhongli J Zhang, Bryan S Nelson, Patricia M Flynn and 3 more

Abstract read
In one paragraph

Article in Open forum infectious diseases, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

13 authors.

Ravi JhaveriDivision of Infectious Diseases, Ann & Robert H. Lurie Children's Hospital of Chicago, Illinois, USA.ORCID https://orcid.org/0000-0001-9921-0419
Kristina M BrooksDepartment of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.ORCID https://orcid.org/0000-0002-3832-8699
Vincent MainellaDepartment of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.ORCID https://orcid.org/0000-0003-1635-2417
John MarcinakGlobal Patient Safety, AbbVie Inc., North Chicago, Illinois, USA.ORCID https://orcid.org/0000-0002-9408-1889
Mong-Jen ChenClinical Pharmacology, AbbVie Inc., North Chicago, Illinois, USA.
Katie McCarthyFHI 360, Durham, North Carolina, USA.ORCID https://orcid.org/0009-0005-3625-332X
Camlin TierneyCenter for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.
Zhongli J ZhangCenter for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.
Bryan S NelsonCenter for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.ORCID https://orcid.org/0000-0002-4964-067X
Patricia M FlynnDepartment of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, Tennessee, USA.
Nathan FurukawaNational Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
Ahizechukwu C EkeDivision of Maternal Fetal Medicine, Department of Gynecology and Obstetrics, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
IMPAACT 2041 Protocol Team

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
NIAID 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

The significant increase in hepatitis C virus (HCV) infection prevalence among young adults, including those who may become pregnant, has led to a corresponding increase in the number of infants exposed to and infected with HCV. Despite a recommendation for universal HCV screening during pregnancy, there is not always a clear pathway to immediately initiate treatment for maternal cure, which could also prevent vertical transmission like the approach for human immunodeficiency virus (HIV) or hepatitis B virus. In 2019, the American Association for the Study of Liver Diseases/Infectious Diseases Society of America HCV Guidelines panel endorsed the use of shared decision making between providers and patients when considering HCV treatment during pregnancy. Direct-acting antivirals, including glecaprevir/pibrentasvir (GLE/PIB), have been tremendously effective in curing >95% of individuals who begin treatment along with an overall well-characterized safety profile, but data supporting their use when initiated during pregnancy are more limited. International Maternal Pediatric Adolescent AIDS Clinical Trials 2041 is a multicenter single-arm phase I/II clinical trial designed to evaluate the pharmacokinetics and safety of GLE/PIB treatment initiated in pregnant women with HCV mono-infection or HCV/HIV co-infection. In this paper, we describe the relevant background data assembled from various sources to write the protocol and design the study.

Indexed as

glecaprevirHepatitis Cpibrentasvirpregnancytreatment

Identifiers

PMID42703521
PMCPMC13546789

What Socratic 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 Socratic graph.