The Treatment in Pregnancy for Hepatitis C ("TiP-HepC") Registry

Launched by THE TASK FORCE FOR GLOBAL HEALTH · May 6, 2022

Keywords

ClinConnect Summary

The "Treatment in Pregnancy for Hepatitis C" (TiP-HepC) study is looking at the safety and effectiveness of certain antiviral medications in pregnant women who have Hepatitis C. The goal is to understand if these medications can help prevent the transmission of the virus from mother to baby during pregnancy. Although these medications have proven to be safe and effective for people who are not pregnant, we don’t have enough information about their use in pregnant women. By collecting data from mothers and their infants around the world, the study aims to learn more about any potential risks during pregnancy and how these treatments might improve outcomes for both mothers and their babies.

To be part of this study, women must be pregnant and have a confirmed diagnosis of chronic Hepatitis C. They should also have taken the approved antiviral medications within 30 days before becoming pregnant. Importantly, treatments known to be harmful during pregnancy are not allowed. Participants can expect to share information about their pregnancy, the treatments they received, and the health of their babies, which will help doctors make informed decisions about treating Hepatitis C in pregnant women in the future. This study is currently recruiting participants, and it welcomes all women regardless of age or background.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • -Documented pregnancy with: Estimated date of conception by documentation of either 1) date of last menstrual period or 2) ultrasound evaluation Actual date of delivery
• • Documented chronic HCV infection prior to or during pregnancy (positive test for HCV RNA or HCV core antigen)
• • Documented DAA exposure occurring within 30 days of the estimated date of conception and before the pregnancy outcome (ie, fetal demise, spontaneous abortion, live delivery, etc). Eligible DAA drugs are listed in Appendix 1.
• Exclusion Criteria:
• • - DAA exposures that include ribavirin or interferon will be excluded given their established harm during pregnancy.