Feasibility and Acceptability of HCV Treatment in Pregnancy
NCT ID: NCT06367465
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2024-02-01
2026-02-28
Brief Summary
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Participant Duration: Approximately 1 year.
Aims:
Aim 1 - Evaluate adherence and treatment completion rates when glecaprevir-pibrentasvir is started during pregnancy for women who use drugs.
Aim 2 - Evaluate patient experience with hepatitis C virus treatment during pregnancy.
Detailed Description
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All consented individuals will participate in four (4) in-person study visits. At the first in-person study visit, patients will receive information about hepatitis C virus treatment, complete testing for HIV and HBV and be assessed for cirrhosis. Patients who meet study criteria will initiate HCV treatment with glecaprevir-pibrentasvir. Patients will return for a second in-person study visit while on HCV treatment (between day 14-56) at which time they will complete a questionnaire about medication adherence and have HCV RNA testing performed. A third in-person study visit will occur at completion of HCV treatment at which time patients will again complete a questionnaire about medication adherence, and have HCV RNA testing performed. The final study visit will occur 4 weeks after completion of HCV treatment at which time patients will have HCV RNA testing performed. All labs that are included as part of the study are standard of care labs for all pregnant women, and are standard of care during HCV treatment (HCV RNA, CBC and CMP).
Additional information about the clinical course of infection (including HCV RNA testing obtained at the time of labor and delivery), and maternal and fetal outcomes will be abstracted from the medical record at 1 year post study enrollment.
All participants will be followed longitudinally in the medical record to ascertain maternal and fetal outcomes and HCV re-infections for up to 1 year post study enrollment.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Female patients ≥ 18 years old, pregnant at the time of study intake, diagnosed with hepatitis c
Female patients ≥ 18 years old, pregnant at the time of study intake, diagnosed with hepatitis c virus infection and a history of past or current drug use.
Glecaprevir-pibrentasvir
Glecaprevir-pibrentasvir 100 mg / 40 mg 3 tab orally (PO) once daily for 56 days.
Interventions
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Glecaprevir-pibrentasvir
Glecaprevir-pibrentasvir 100 mg / 40 mg 3 tab orally (PO) once daily for 56 days.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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Washington University School of Medicine
OTHER
Responsible Party
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Locations
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Barnes Jewish Hospital
St Louis, Missouri, United States
Washington Univeristy
St Louis, Missouri, United States
Countries
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Central Contacts
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Facility Contacts
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Tracey Bach
Role: primary
Laura Marks, MD,PhD
Role: primary
Tracey Habrock-Bach, MBA
Role: backup
References
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Rossi RM, Wolfe C, Brokamp R, McAllister JM, Wexelblatt S, Warshak CR, Hall ES. Reported Prevalence of Maternal Hepatitis C Virus Infection in the United States. Obstet Gynecol. 2020 Feb;135(2):387-395. doi: 10.1097/AOG.0000000000003644.
ACOG Committee Opinion No. 736: Optimizing Postpartum Care. Obstet Gynecol. 2018 May;131(5):e140-e150. doi: 10.1097/AOG.0000000000002633.
Bryant AS, Haas JS, McElrath TF, McCormick MC. Predictors of compliance with the postpartum visit among women living in healthy start project areas. Matern Child Health J. 2006 Nov;10(6):511-6. doi: 10.1007/s10995-006-0128-5.
Wilcox A, Levi EE, Garrett JM. Predictors of Non-Attendance to the Postpartum Follow-up Visit. Matern Child Health J. 2016 Nov;20(Suppl 1):22-27. doi: 10.1007/s10995-016-2184-9.
Weir S, Posner HE, Zhang J, Willis G, Baxter JD, Clark RE. Predictors of prenatal and postpartum care adequacy in a medicaid managed care population. Womens Health Issues. 2011 Jul-Aug;21(4):277-85. doi: 10.1016/j.whi.2011.03.001. Epub 2011 May 12.
Bushman ET, Subramani L, Sanjanwala A, Dionne-Odom J, Franco R, Owen J, Subramaniam A. Pragmatic Experience with Risk-based versus Universal Hepatitis C Screening in Pregnancy: Detection of Infection and Postpartum Linkage to Care. Am J Perinatol. 2021 Sep;38(11):1109-1116. doi: 10.1055/s-0041-1728827. Epub 2021 May 2.
Jarlenski M, Chen Q, Ahrens KA, Allen L, Austin AE, Chappell C, Donohue JM, Hammerslag L, Lanier P, McDuffie MJ, Talbert J, Tang L, Krans EE; Medicaid Outcomes Distributed Research Network (MODRN). Postpartum Follow-up Care for Pregnant Persons With Opioid Use Disorder and Hepatitis C Virus Infection. Obstet Gynecol. 2022 May 1;139(5):916-918. doi: 10.1097/AOG.0000000000004760. Epub 2022 Apr 5.
Epstein RL, Sabharwal V, Wachman EM, Saia KA, Vellozzi C, Hariri S, Linas BP. Perinatal Transmission of Hepatitis C Virus: Defining the Cascade of Care. J Pediatr. 2018 Dec;203:34-40.e1. doi: 10.1016/j.jpeds.2018.07.006. Epub 2018 Aug 28.
Kushner T, Lange M, Sperling R, Dieterich D. Treatment of Women With Hepatitis C Diagnosed in Pregnancy: a Co-Located Treatment Approach. Gastroenterology. 2022 Nov;163(5):1454-1456.e1. doi: 10.1053/j.gastro.2022.07.017. Epub 2022 Jul 18. No abstract available.
Zeng QL, Yu ZJ, Lv J, Zhang HX, Wang B, Dong XP, Chen ZM, Cui GL, Ji F. Sofosbuvir-based therapy for late pregnant women and infants with severe chronic hepatitis C: A case series study. J Med Virol. 2022 Sep;94(9):4548-4553. doi: 10.1002/jmv.27877. Epub 2022 Jun 1.
AbdAllah M, Alboraie M, Abdel-Razek W, Hassany M, Ammar I, Kamal E, Alalfy M, Okasha A, El Akel W, Shaaban E, Elbaz T, Hefny Z, Gomaa A, El-Bendary M, El-Serafy M, Esmat G, Doss W, El-Sayed MH. Pregnancy outcome of anti-HCV direct-acting antivirals: Real-life data from an Egyptian cohort. Liver Int. 2021 Jul;41(7):1494-1497. doi: 10.1111/liv.14913. Epub 2021 May 11.
Chappell CA, Scarsi KK, Kirby BJ, Suri V, Gaggar A, Bogen DL, Macio IS, Meyn LA, Bunge KE, Krans EE, Hillier SL. Ledipasvir plus sofosbuvir in pregnant women with hepatitis C virus infection: a phase 1 pharmacokinetic study. Lancet Microbe. 2020 Sep;1(5):e200-e208. doi: 10.1016/S2666-5247(20)30062-8. Epub 2020 Jul 27.
Bhattacharya D, Aronsohn A, Price J, Lo Re V; AASLD-IDSA HCV Guidance Panel. Hepatitis C Guidance 2023 Update: AASLD-IDSA Recommendations for Testing, Managing, and Treating Hepatitis C Virus Infection. Clin Infect Dis. 2023 May 25:ciad319. doi: 10.1093/cid/ciad319. Online ahead of print.
Other Identifiers
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202308056
Identifier Type: -
Identifier Source: org_study_id