Clinical trial NCT06367465: Feasibility and Acceptability of HCV Treatment in Pregnancy
Official title: Feasibility and Acceptability of Early Linkage to HCV Treatment in Pregnancy Feasibility and Acceptability of Early Linkage to HCV Treatment in Pregnancy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatitis C
Pregnancy Complications
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Medication adherence and treatment completion rates.
timeFrame: 2 years
Secondary outcomes:
measure: Patient satisfaction Questionnaire
timeFrame: 2 years
measure: Virologic outcome and clinical success at Day 28 post treatment
timeFrame: 2 years
measure: Sample size estimation for future study
timeFrame: 2 years
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Washington Univeristy
state: Missouri
Study officials:
References:
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