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NCT Number: NCT06367465

Feasibility and Acceptability of 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.

Recruiting

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Female Urogenital Diseases and Pregnancy Complications Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Pregnancy Complications RNA Virus Infections Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Barnes Jewish Hospital, St Louis, Missouri, United States

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Glecaprevir-pibrentasvir

Drug

Glecaprevir-pibrentasvir 100 mg / 40 mg 3 tab orally (PO) once daily for 56 days.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Patient satisfaction Questionnaire

    Time frame: 2 years

    To assess patient satisfaction with early initiation of glecaprevir-pibrentasvir during pregnancy.

  2. 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.

  3. Sample size estimation for future study

    Time frame: 2 years

    Sample size estimation for future study

Study contacts

Contact information is provided by the study sponsor or research team.

Laura Marks, MD, PhD

CONTACT

[email protected]

Tracey Bach, MBA

CONTACT

[email protected]

314-273-6075

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 16, 2024
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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