Feasibility and Acceptability of HCV Treatment in Pregnancy

April 11, 2024 updated by: Washington University School of Medicine

Feasibility and Acceptability of Early Linkage to HCV Treatment in Pregnancy Feasibility and Acceptability of Early Linkage to HCV Treatment in Pregnancy

Pregnant adults over the age of 18 who are seen in the Washington University obstetrics and gynecology, maternal fetal medicine or infectious diseases clinic or admitted to BJH with hepatitis C virus infection who have a history of past or current drug use

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Pregnant adults over the age of 18 with a history of either past or current drug use who are seen in the Washington University obstetrics and gynecology, maternal fetal medicine or infectious diseases clinic or admitted to BJH with hepatitis C virus infection who consent to participate in the study will be treated with glecaprevir-pibrentasvir.

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.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Barnes Jewish Hospital
        • Contact:
        • Principal Investigator:
          • Laura Marks, MD, PhD
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington Univeristy
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Adults over the age of 18 with hepatitis C virus infection who are currently pregnant with a history of past or current drug use. Patients must have health insurance which covers hepatitis C virus treatment with direct acting antivirals and who agree to begin HCV treatment with glecaprevir-pibrentasvir during pregnancy. Participants pregnancies must have reached at least 10 weeks gestational age prior to initiation of medication. Adults over the age of 18 with hepatitis C virus infection who are currently pregnant with a history of past or current drug use. Patients must have health insurance which covers hepatitis C virus treatment with direct acting antivirals and who agree to begin HCV treatment with glecaprevir-pibrentasvir during pregnancy. Participants pregnancies must have reached at least 10 weeks gestational age prior to initiation of medication.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: Glecaprevir-pibrentasvir
Glecaprevir-pibrentasvir 100 mg / 40 mg 3 tab orally (PO) once daily for 56 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication adherence and treatment completion rates.
Time Frame: 2 years
The primary objective of this study is to assess patient adherence and treatment completion rates of women with a history of past or current drug use who receive initiation of Hepatitis C Virus treatment with glecaprevir-pibrentasvir during pregnancy. The primary objective of this study is to assess patient adherence and treatment completion rates of women with a history of past or current drug use who receive initiation of Hepatitis C Virus treatment with glecaprevir-pibrentasvir during pregnancy.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction Questionnaire
Time Frame: 2 years
To assess patient satisfaction with early initiation of glecaprevir-pibrentasvir during pregnancy.
2 years
Virologic outcome and clinical success at Day 28 post treatment
Time Frame: 2 years
Virologic and clinical outcomes at 4 weeks after completion of glecaprevir-pibrentasvir between patients who received glecaprevir-pibrentasvir during pregnancy and to those who received it post-partum.
2 years
Sample size estimation for future study
Time Frame: 2 years
Sample size estimation for future study
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Estimated)

February 28, 2026

Study Completion (Estimated)

February 28, 2026

Study Registration Dates

First Submitted

March 6, 2024

First Submitted That Met QC Criteria

April 11, 2024

First Posted (Actual)

April 16, 2024

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202308056

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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