NCT06367465

Feasibility and Acceptability of HCV Treatment in Pregnancy

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: —

Summary

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.

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.

Conditions

• Hepatitis C
• Pregnancy Complications

Interventions

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

Timeline

• Start date: 2024-02-01
• Primary completion: 2026-02-28
• Completion: 2026-02-28
• First posted: 2024-04-16
• Last updated: 2025-12-29

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study