Reported Prevalence of Maternal Hepatitis C Virus Infection in the United States.
Robert M Rossi, Christopher Wolfe, Richard Brokamp...
https://pubmed.ncbi.nlm.nih.gov/31923064Actively Recruiting
Age: 18Years +
FEMALE
ID06367465
Feasibility and Acceptability of Early Linkage to HCV Treatment in Pregnancy
Led by Washington University School of Medicine · Updated on 2025-12-29
50
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to study pregnant adults aged 18 and older who have hepatitis C virus infection and a history of past or current drug use. The focus is on evaluating the use of glecaprevir-pibrentasvir treatment during pregnancy, examining both how well patients stick to the treatment and their overall experience. The study is conducted by Washington University School of Medicine and involves patients seen in obstetrics, maternal fetal medicine, or infectious diseases clinics, or admitted to the affiliated hospital. Participants will receive glecaprevir-pibrentasvir at a dose of 100 mg / 40 mg, taking three tablets orally once daily for 56 days. There are four in-person visits scheduled: the first includes education about hepatitis C treatment, testing for HIV and HBV, and assessment for liver cirrhosis. Treatment starts if criteria are met. The second visit occurs between days 14 and 56 during treatment and involves medication adherence questionnaires and viral RNA testing. The third visit is at treatment completion, with similar assessments. The final visit is four weeks later, focusing on viral RNA testing. Throughout the study, participants will have standard lab tests common in pregnancy and hepatitis C care, including viral RNA, blood counts, and metabolic panels. Researchers will also review medical records for maternal and fetal health outcomes and hepatitis C reinfection status for up to one year after enrollment. The main outcome is medication adherence and treatment completion, with additional assessments of patient satisfaction and virologic success. Total participation lasts about one year.
CONDITIONS
Brief Title
Feasibility and Acceptability of HCV Treatment in Pregnancy
Who Can Participate
Age: 18Years +
FEMALE
Eligibility Criteria
You may qualify if you...
- Female patients 18 years or older
- Pregnant at the time of study intake
- Diagnosed with hepatitis C virus infection
- History of past or current drug use
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 56 days
Participants receive HCV treatment with glecaprevir-pibrentasvir lasting 56 days. During treatment, participants complete questionnaires about medication adherence and have HCV RNA testing performed.
3 visits (in-person): one at treatment start, one between day 14-56, and one at treatment completion
Follow-up
Duration - 4 weeks plus up to 1 year of medical record follow-up
Participants return for a final study visit 4 weeks after completing HCV treatment to have HCV RNA testing performed. Maternal and fetal outcomes and HCV re-infections are monitored via medical records for up to 1 year post enrollment.
1 visit (in-person) plus ongoing medical record monitoring
Trial Site Locations
Total: 2 locations
1
Barnes Jewish Hospital
St Louis, Missouri, United States, 63110
Actively Recruiting
2
Washington Univeristy
St Louis, Missouri, United States, 63110
Actively Recruiting
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Research Team
T
Tracey Bach, MBA
L
Laura Marks, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
ACOG Committee Opinion No. 736: Optimizing Postpartum Care.
https://pubmed.ncbi.nlm.nih.gov/29683911Predictors of compliance with the postpartum visit among women living in healthy start project areas.
Allison S Bryant, Jennifer S Haas, Thomas F McElrath...
https://pubmed.ncbi.nlm.nih.gov/16807794Predictors of Non-Attendance to the Postpartum Follow-up Visit.
Annemieke Wilcox, Erika E Levi, Joanne M Garrett
https://pubmed.ncbi.nlm.nih.gov/27562797Predictors of prenatal and postpartum care adequacy in a medicaid managed care population.
Sharada Weir, Heather E Posner, Jianying Zhang...
https://pubmed.ncbi.nlm.nih.gov/21565526Pragmatic Experience with Risk-based versus Universal Hepatitis C Screening in Pregnancy: Detection of Infection and Postpartum Linkage to Care.
Elisa T Bushman, Lakshmi Subramani, Aalok Sanjanwala...
https://pubmed.ncbi.nlm.nih.gov/33934324Postpartum Follow-up Care for Pregnant Persons With Opioid Use Disorder and Hepatitis C Virus Infection.
Marian Jarlenski, Qingwen Chen, Katherine A Ahrens...
https://pubmed.ncbi.nlm.nih.gov/35576352Perinatal Transmission of Hepatitis C Virus: Defining the Cascade of Care.
Rachel L Epstein, Vishakha Sabharwal, Elisha M Wachman...
https://pubmed.ncbi.nlm.nih.gov/30170857Treatment of Women With Hepatitis C Diagnosed in Pregnancy: a Co-Located Treatment Approach.
Tatyana Kushner, Marcia Lange, Rhoda Sperling...
https://pubmed.ncbi.nlm.nih.gov/35863531Sofosbuvir-based therapy for late pregnant women and infants with severe chronic hepatitis C: A case series study.
Qing-Lei Zeng, Zu-Jiang Yu, Jun Lv...
https://pubmed.ncbi.nlm.nih.gov/35595682