Clinical trials

This study in Phichit province, Thailand, aims to find and support adults born before 1992 who are at high risk for hepatitis B infection. Many people in this group were born before the universal hepatitis B vaccine was available and may not know they are infected. The study will invite nearly 240,000 eligible adults for free hepatitis B screening. Those who test positive will be linked to care at one of 12 district hospitals. Doctors will use simplified 2024 World Health Organization (WHO) guidelines to decide who needs treatment. Eligible individuals will receive a safe, effective daily medicine (tenofovir alafenamide). The study will use community health volunteers and phone reminders to help patients stay in care and take their medication regularly. Over three years, the study will track improvements in liver health and virus levels, aiming to prevent liver cirrhosis and cancer.

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.