Randomized Trial of Oral Tenofovir alafenamide Fumarate Treatment for Adults With Chronic Hepatitis B, Normal Liver Enzyme Levels, and Positive Virus DNA

What This Trial Is About

Researchers are evaluating the clinical effects and safety of nucleoside acid analogues treatment in patients who have chronic Hepatitis B virus infection with normal alanine aminotransferase ALT levels but positive Hepatitis B virus DNA. Although current guidelines do not recommend antiviral treatment for these patients, viral replication is linked to higher risks of cirrhosis and liver tumors. This trial aims to study whether nucleoside acid analogues can reduce viral load and support liver recovery with minimal side effects. Participants are randomly assigned to one of two groups one group receives oral Tenofovir alafenamide Fumarate TAF 25 mg once daily starting at baseline and continuing lifelong unless they achieve hepatitis B surface antigen loss, while the other group receives no treatment and is observed over the same period. The study compares the effects and safety between those treated with TAF and those without antiviral therapy. During the study, participants undergo evaluations of hepatitis B surface antigen decrease at 48, 96, and 144 weeks. Secondary measures include rates of hepatitis B e antigen loss, HBV DNA undetectable rates, HBV RNA undetectable rates, and hepatitis B surface antigen loss at these time points. Safety and treatment effects are monitored throughout, and participants may be involved in this randomized controlled trial for an extended period, potentially lifelong.

Nucleoside (Acid) Analogues Treatment in Patients With Normal ALT and Positive HBVDNA.