Investigating the safety and effectiveness of a hepatitis C treatment during pregnancy
Official title: IMPAACT 2041: PHASE I/II STUDY OF THE PHARMACOKINETICS AND SAFETY OF GLECAPREVIR/PIBRENTASVIR INITIATED IN PREGNANCY IN PEOPLE WITH HEPATITIS C WITH AND WITHOUT HIV
Funded at Westat, INC. · NIH-11344777 · Data updated 2026-11-12
This study is looking at how safe and effective the medications Glecaprevir and Pibrentasvir are for pregnant people with hepatitis C, including those with HIV, and will track their health and their baby's health for three months after birth to make sure everyone stays safe and healthy.
Quick facts
| Grant type | NIH-funded research |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Westat, INC. NIH-funded |
| Lab location | 1 site (Rockville, United States) |
| Project start | March 7, 2025 |
| Project end | July 31, 2028 |
| Funding year | 2025 |
| Award (this year) | $1,125,154 |
| NIH project number | 75N94023D00001-0-759402500001-1 |
| Project ID | NIH-11344777 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates for this research include pregnant individuals diagnosed with hepatitis C, with or without HIV.
✕Less likely to help
Patients who are not pregnant or those without hepatitis C may not benefit from this research.
What this research studies
This research focuses on understanding how the medications Glecaprevir and Pibrentasvir work in pregnant individuals with hepatitis C, including those who are also living with HIV. The study will monitor the safety of these medications for both the pregnant person and their infant, tracking health outcomes for three months after birth. Participants will be closely observed to gather data on how the drugs are processed in the body during pregnancy and postpartum. The goal is to ensure that effective treatments can be safely administered to this vulnerable population.
Why it matters
Potential benefit: If successful, this research could lead to safer treatment options for pregnant individuals with hepatitis C, improving health outcomes for both mothers and their infants.
How similar studies have gone: Previous research has shown promise in treating hepatitis C in various populations, but this specific approach during pregnancy is relatively novel.
Where this research is happening
-
Westat, INC.
Rockville, United States Active
Researchers
- Principal investigator: Driver, Barbara — Westat, INC.
- Study coordinator: Driver, Barbara
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About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.