Peer-reviewed article
IMPAACT 2041: Designing the Study of Glecaprevir/Pibrentasvir Treatment During Pregnancy.
Jhaveri R, Brooks KM, Mainella V, Marcinak J, Chen MJ et al. ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001This paper describes the design and rationale for IMPAACT 2041, a clinical trial studying the safety and pharmacokinetics of glecaprevir/pibrentasvir (a hepatitis C treatment) when given to pregnant women. The study was motivated by increasing hepatitis C infection among young adults and the potential to prevent vertical transmission to infants. The trial will enroll pregnant women with hepatitis C alone or with HIV co-infection to evaluate whether this direct-acting antiviral drug is safe and effective during pregnancy.
Key points
- Hepatitis C prevalence has increased among young adults, including pregnant women, leading to more infants with HCV exposure or infection
- Direct-acting antivirals like glecaprevir/pibrentasvir cure >95% of non-pregnant HCV patients but safety data during pregnancy are limited
- IMPAACT 2041 is a multicenter single-arm phase I/II trial designed to evaluate pharmacokinetics and safety of GLE/PIB in pregnant women
- 2019 guidelines recommend shared decision-making between providers and patients regarding HCV treatment during pregnancy
- The paper assembles background data to justify the trial protocol but does not present trial results
Limitations
This is a protocol paper describing study design, not a results paper, so it contains no outcome data or evidence of effectiveness. It does not evaluate the actual impact of the intervention on maternal or infant health outcomes.
Abstract
The significant increase in hepatitis C virus (HCV) infection prevalence among young adults, including those who may become pregnant, has led to a corresponding increase in the number of infants exposed to and infected with HCV. Despite a recommendation for universal HCV screening during pregnancy, there is not always a clear pathway to immediately initiate treatment for maternal cure, which could also prevent vertical transmission like the approach for human immunodeficiency virus (HIV) or hepatitis B virus. In 2019, the American Association for the Study of Liver Diseases/Infectious Diseases Society of America HCV Guidelines panel endorsed the use of shared decision making between providers and patients when considering HCV treatment during pregnancy. Direct-acting antivirals, including glecaprevir/pibrentasvir (GLE/PIB), have been tremendously effective in curing >95% of individuals who begin treatment along with an overall well-characterized safety profile, but data supporting their use when initiated during pregnancy are more limited. International Maternal Pediatric Adolescent AIDS Clinical Trials 2041 is a multicenter single-arm phase I/II clinical trial designed to evaluate the pharmacokinetics and safety of GLE/PIB treatment initiated in pregnant women with HCV mono-infection or HCV/HIV co-infection. In this paper, we describe the relevant background data assembled from various sources to write the protocol and design the study.