Hepatitis C Guidance 2023 Update: AASLD-IDSA Recommendations for Testing, Managing, and Treating Hepatitis C Virus Infection.
Debika Bhattacharya, Andrew Aronsohn, Jennifer Price...
https://pubmed.ncbi.nlm.nih.gov/37229695/Actively Recruiting
Led by Washington University School of Medicine · Updated on 2026-06-09
50
Participants Needed
2
Research Sites
N/A
Total Duration
This research focuses on pregnant adults aged 18 and older who have hepatitis C virus infection and a history of past or current drug use. It aims to evaluate how well pregnant women can adhere to and complete treatment with glecaprevir-pibrentasvir during pregnancy, as well as to understand their experiences with hepatitis C treatment during this time. Participants will receive glecaprevir-pibrentasvir, taken orally once daily for 56 days. The study includes four in-person visits the first to provide treatment information and perform tests including HIV, HBV, and cirrhosis assessment the second during treatment to assess medication adherence and viral load the third at treatment completion to repeat these assessments and a final visit four weeks after treatment ends for viral load testing. Additional clinical information and maternal and fetal outcomes will be collected from medical records up to one year after enrollment. Throughout the study, participants will undergo standard laboratory tests such as HCV RNA, complete blood count, and metabolic panel. Researchers will monitor medication adherence, treatment completion rates, patient satisfaction, virologic response, and clinical success. Maternal and fetal health outcomes and any hepatitis C reinfections will be followed through medical records for one year, with the total participation lasting about one year.
CONDITIONS
Feasibility and Acceptability of HCV Treatment in Pregnancy
T
Tracey Bach, MBA
L
Laura Marks, MD, PhD
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Washington University School of Medicine
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 56 days
Participants receive glecaprevir-pibrentasvir once daily for 56 days and complete questionnaires about medication adherence. Blood tests for hepatitis C viral load are performed during and after treatment.
4 in-person visits
Duration - Up to 1 year
Researchers collect information from medical records on maternal and fetal outcomes and any hepatitis C reinfections for up to 1 year after enrollment.
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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