Tenofovir in Chronic Hepatitis B With Mild ALT Elevation

Phase 4 Completed 160 enrolled E-DA Hospital Gilead Sciences · collab Taipei Institute of Pathology · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

This study aims to clarify whether patients with chronic hepatitis B with high viral load will benefit from oral antiviral therapy despite only mildly elevated serum liver enzyme.

Timeline

Start: 2012-01
Primary completion: 2018-11
Completion: 2018-12

Outcome

Mixed primary results

paper relative risk [RR] 0·56, 95% CI 0·35-0·88; p=0·013 PMID 33524314 ↗

paper necroinflammation progressed (an increase of ≥2 points) in five (7%, 95% CI 2-15) patients in the tenofovir disoproxil fumarate group and in 12 (16%, 9-27) patients in the placebo group (RR 0·42, 95% CI 0·15-1·12; p=0·084). PMID 33524314 ↗

Publications

Hsu YC, Chen CY, Chang IW, Chang CY, Wu CY, Lee TY, Wu MS, Bair MJ, Chen JJ, Chen CC, Tseng CH, Tai CM, Huang YT, Ku WH, Mo LR, Lin JT. Once-daily tenofovir disoproxil fumarate in treatment-naive Taiwanese patients with chronic hepatitis B and minimally raised alanine aminotransferase (TORCH-B): a multicentre, double-blind, placebo-controlled, parallel-group, randomised trial. Lancet Infect Dis. 2021 Jun;21(6):823-833. doi: 10.1016/S1473-3099(20)30692-7. Epub 2021 Jan 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tenofovir disoproxil fumarate	Small molecule	300 mg	Oral