Synergistic Effect of Biejia-Ruangan on Fibrosis Regression in Patients With Chronic Hepatitis B Treated With Entecavir: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial.

Abstract

BACKGROUND:

Long-term nucleos(t)ide analogue (NA) treatment can reverse liver fibrosis in chronic hepatitis B (CHB), but its effect on fibrosis regression remains limited. Biejia-Ruangan (BR) has been approved in China as an antifibrotic traditional Chinese medicine drug in patients with chronic liver diseases. A multicenter randomized controlled trial aims to evaluate the effect of BR on fibrosis regression in CHB patients treated with NAs.

METHODS:

CHB patients with histologically confirmed advanced fibrosis or cirrhosis were randomly assigned to receive entecavir (ETV) (0.5 mg per day) plus BR (2 g 3 times a day) or placebo for 72 weeks. Liver fibrosis regression was defined as a reduction of ≥ 1 point by the Ishak fibrosis stage (IFS).

RESULTS:

Overall, 500 patients were enrolled in each group as the intention-to-treat population. The rate of fibrosis regression after 72 weeks of treatment was significantly higher in the ETV + BR group (40% vs 31.8%; P = .0069). Among 388 patients with cirrhosis (ie, IFS ≥ 5) at baseline, the rate of cirrhosis reversal (ie, IFS ≤ 4) was significantly higher in the ETV + BR group (41.5% vs 30.7%; P = .0103).

CONCLUSIONS:

Addition of BR to the current standard treatment with NAs in CHB patients with advanced fibrosis or cirrhosis can improve liver fibrosis regression.

CLINICAL TRIALS REGISTRATION:

NCT01965418.

• Authors: Guanghua Rong, Yongping Chen, Zujiang Yu, Qin Li, Jingfeng Bi, Lin Tan, Dedong Xiang, Qinghua Shang, Chunliang Lei, Liang Chen, Xiaoyu Hu, Jing Wang, Huabao Liu, Wei Lu, Yan Chen, Zheng Dong, Wenlin Bai, Eric M Yoshida, Nahum Mendez-Sanchez, Ke-Qin Hu, Xingshun Qi, Yongping Yang
• Journal: The Journal of infectious diseases (J Infect Dis) Vol. 225 Issue 6 Pg. 1091-1099 (03 15 2022) ISSN: 1537-6613 [Electronic] United States
• PMID: 32437567 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America.

Chemical References

• Antiviral Agents
• entecavir
• Guanine

Topics

• Antiviral Agents
• Guanine (analogs & derivatives, therapeutic use)
• Hepatitis B, Chronic (complications, drug therapy)
• Humans
• Liver Cirrhosis (chemically induced, drug therapy)
• Treatment Outcome