An Observational Study of Mother-Infant Outcomes Following Antenatal Exposure to Direct-Acting Antivirals: the Treatment in Pregnancy for Hepatitis C ("TiP-HepC") Registry
The Task Force for Global Health
Summary
Clinical interventions to reduce the risk of vertical transmission of hepatitis C virus (HCV) infection from mother to infant are highly limited. Direct-acting antiviral (DAA) medications have demonstrated excellent safety and efficacy in non-pregnant individuals, but there is a lack of data regarding the safety of these medications in pregnant women and the effectiveness of these medications in reducing mother-to-child transmission. Therefore, although HCV screening during pregnancy is now recommended in many countries, there is no approved treatment for HCV during pregnancy. An observational study is here proposed to assess outcomes of mother-infant pairs exposed to DAAs during pregnancy within a global clinical case registry. Data regarding the exposures and outcomes of mother-infant pairs exposed to DAAs during pregnancy will be solicited and collected from clinical providers, healthcare facilities, HCV treatment programs, and other clinical practices worldwide. Data will be shared and maintained within a secure database, and cumulative data will be analyzed at pre-determined six-month intervals. The primary outcome will be the number and proportion of mother-infant pairs with adverse pregnancy or birth outcomes. The results of this study will inform HCV treatment decisions by clinical providers and programs worldwide.
Description
In 2016, approximately 6% of all women who were tested for HCV during pregnancy in the United States were HCV antibody-positive. That year, there were 14,417 live births delivered by HCV-positive women, which comprised 0.38% of all live births in the US. Globally, the HCV prevalence among pregnant women varies widely (0.06%-7%) depending on regional and local epidemiology and risk factors. Approximately 5.8% of infants born to HCV-infected mothers will acquire HCV infection with higher rates of transmission among women with HIV co-infection. The primary route for the vertical transmission of H…
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- Yes
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 inter…
Interventions
- DrugDirect Acting Antivirals
Direct-acting antiviral exposure during documented pregnancy
Location
- The Taskforce for Global HealthAtlanta, Georgia