Hepatitis E Virus Infection

Hepatitis is an inflammatory condition of the liver that has emerged as a significant global health concern due to its widespread prevalence. Data on ursodeoxycholic acid in acute viral hepatitis remain limited. Some studies suggest its positive effect in cholestatic phase of viral hepatitis. UDCA may reduce cholestatic symptoms like jaundice and pruritus potentially shortening hospital stay and improving patient outcomes. However, robust clinical data supporting its routine use in acute viral hepatitis are lacking, and current treatment remains largely supportive. Given the high burden of acute viral hepatitis in our region and the potential for UDCA to improve cholestatic phase of AVH there is a clear need for well-designed clinical studies evaluating its therapeutic role. This study aims to evaluate the role of oral ursodeoxycholic acid in biochemical recovery of patients with acute viral hepatitis. If positive role is confirmed, it will be incorporated in standard treatment and if no role is found unnecessary use will be discouraged. Null Hypothesis (H₀): Oral ursodeoxycholic acid has no significant effect on the bilirubin levels of patients with acute viral hepatitis. H₀: There is no statistically significant difference in bilirubin levels between patients receiving ursodeoxycholic acid and those receiving supportive care alone. Alternative Hypothesis (H₁): Oral ursodeoxycholic acid reduces bilirubin levels in patients with acute viral hepatitis. H₁: There is statistically significant difference in bilirubin levels between patients receiving ursodeoxycholic acid and those receiving supportive care alone.

The primary goal of this clinical trial is to demonstrate non-inferiority of 30 µg of Hecolin® in healthy children, compared to healthy adults as measured by seroresponse rates (SR) of anti-HEV IgG titers, 4 weeks after 3 doses (0, 1 and 6 months) and to assess and descriptively compare safety profile data intra and inter age Strata. As secondary objectives, Geometric Mean Concentration (GMC) of anti-HEV IgG ELISA will be evaluated 4 weeks after 3 doses (0, 1 and 6 months) and 4 weeks after 2 doses (0- and 6-months dose) in healthy children. SR and GMC will also be evaluated 24 weeks after 3 doses and 2 doses. The immune response will be compared among adult participants between HIV positive and HIV negative individuals and between virally suppressed and virally unsuppressed HIV positive individuals