Glecaprevir/pibrentasvir started during pregnancy for women with hepatitis C, with or without HIV
Phase I/II Study of the Pharmacokinetics and Safety of Glecaprevir/Pibrentasvir Initiated in Pregnancy in Women With Hepatitis C With and Without HIV
This trial will test whether taking glecaprevir/pibrentasvir during pregnancy is safe and how the drug is processed in pregnant women who have hepatitis C, including those who also have HIV, and will follow their infants for 10 weeks after birth.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 16 Years to 45 Years |
| Sex | Female |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) NIH |
| Locations | 10 sites (Los Angeles, California and 9 other locations) |
| Trial ID | NCT07040319 on ClinicalTrials.gov |
What this trial studies
This is a Phase 1/2, open-label, single-arm, multi-site trial that gives glecaprevir/pibrentasvir to pregnant women with detectable HCV RNA between 14 and 32 weeks gestation to describe drug pharmacokinetics and maternal and infant safety. Participants may have HIV or not and will undergo blood sampling for drug levels and routine safety labs during treatment and through delivery. Infants will be followed for safety outcomes through 10 weeks postpartum, and maternal virologic response will be recorded. The trial excludes multiple gestation, fetal anomalies, intrauterine growth restriction, and hepatitis B surface antigen-positive mothers.
Who should consider this trial
Good fit: Pregnant people aged 16–45 with a single fetus at 14–32 weeks gestation, detectable HCV RNA, and willingness to consent for themselves and their infant are the intended participants; people may have or not have HIV.
Not a fit: People with multiple gestation, fetal anomalies, intrauterine growth restriction, or active hepatitis B infection are excluded and may not receive benefit from this protocol.
Why it matters
Potential benefit: If successful, this could allow safe use of glecaprevir/pibrentasvir during pregnancy to treat mothers with hepatitis C and potentially reduce perinatal transmission.
How similar studies have performed: Direct-acting antivirals like glecaprevir/pibrentasvir are highly effective in nonpregnant patients, but use during pregnancy is relatively untested and pharmacokinetic and safety data in pregnant people are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Of legal age or circumstance to provide independent informed consent as determined by site standard operating procedures (SOPs) and consistent with institutional review board/ethics committee (IRB/EC) policies and procedures * Willing and able to provide written informed consent for their own and their infant's study participation * At entry, 16-45 years of age (inclusive) * At entry, gestational age of 14-32 weeks, defined as greater than 13 weeks plus six days and less than or equal to 32 completed weeks gestation, as determined by the site investigator based on best obstetric estimate * At screening and at study entry, no evidence of multiple gestation, fetal anomalies, or intrauterine fetal growth restriction, as determined by the site investigator based on ultrasound * At screening, detectable HCV RNA test result based on testing of a specimen collected within 30 days prior to entry * At screening, negative test results for hepatitis B surface antigen based on testing of a specimen collected within 30 days prior to entry * At screening (i.e., from specimens collected within 30 days prior to entry), has normal, grade 1, grade 2, or grade 3 results for the following * Aspartate aminotransferase (AST) (\<10.0 x ULN) * Alanine aminotransferase (ALT) (\<10.0 x ULN) * At screening (i.e., from specimens collected within 30 days prior to entry), has normal, grade 1, or grade 2 results for the following * Hemoglobin (≥8.5 g/dL) * Creatinine (≤1.8 x ULN) * At screening (i.e., from specimens collected within 30 days prior to entry), has normal or grade 1 results for the following * International normalized ratio (INR) (\<1.5 x ULN) * Platelet count (≥100,000 cells/mm3) * Total bilirubin (\<1.6 x ULN) * HIV status determined based on testing meeting the requirements specified in protocol * For pregnant participants living with HIV: has a suppressed HIV viral load (HIV-1 RNA below the limit of quantification of the assay) on an ARV regimen for at least 30 consecutive days prior to entry that does not include efavirenz, etravirine, cobicistat, or any protease inhibitor (e.g., atazanavir, darunavir, lopinavir, ritonavir), as determined by the site investigator based on available medical records * At entry, expects to remain in the geographic area of the study site during pregnancy and for 10 weeks postpartum (or for 20 weeks post-entry, depending on gestational age at entry), as determined by the site investigator based on pregnant participant report Exclusion Criteria: * Any previous treatment for hepatitis C, including HCV DAAs or interferon-based treatment * High risk of preterm delivery, defined as either of the following: * History of spontaneous preterm delivery at less than 34 weeks, as determined by the site investigator based on pregnant participant report and available medical records, or * Shortened cervix less than 20 mm if noted on ultrasound during the current pregnancy, as determined by the site investigator based on available medical records * Receipt of any prohibited medication, within 14 days prior to entry, as determined by the site investigator based on pregnant participant report and available medical records * Any of the following liver-related conditions: * Clinical diagnosis of acute hepatitis not otherwise attributable to hepatitis C with AST or ALT ≥2.5 x ULN * Evidence of decompensated cirrhosis including history of or present variceal hemorrhage, ascites, spontaneous bacterial peritonitis, hepatic encephalopathy, hepatocellular carcinoma, hepatorenal syndrome, or hepatopulmonary syndrome * Has any other documented or suspected clinically significant medical condition or any other condition that, in the opinion of the site investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving study objectives
Where this trial is running
Los Angeles, California and 9 other locations
- USC la — Los Angeles, California, United States (Recruiting)
- David Geffen School of Medicine at UCLA — Los Angeles, California, United States (Not_yet_recruiting)
- University of Colorado Denver — Aurora, Colorado, United States (Recruiting)
- Univ. of Florida Jacksonville — Jacksonville, Florida, United States (Recruiting)
- Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (Recruiting)
- Johns Hopkins University Baltimore — Baltimore, Maryland, United States (Recruiting)
- SUNY Stony Brook — Stony Brook, New York, United States (Recruiting)
- Bronx-Lebanon Hospital Center — The Bronx, New York, United States (Recruiting)
- Jacobi Medical Center — The Bronx, New York, United States (Not_yet_recruiting)
- Baylor College of Medicine//Texas Children's Hospital — Houston, Texas, United States (Recruiting)
Study contacts
- Study coordinator: IMPAACT ClinicalTrials.gov Coordinator
- Email: impaact.ctgov@fstrf.org
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.