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

Number of adverse pregnancy outcomes,Number of adverse birth outcomes

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.