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. (21st May 2020)

• Record Type: Journal Article
• Authors: Rong, Guanghua; Chen, Yongping; Yu, Zujiang; Li, Qin; Bi, Jingfeng; Tan, Lin; Xiang, Dedong; Shang, Qinghua; Lei, Chunliang; Chen, Liang; Hu, Xiaoyu; Wang, Jing; Liu, Huabao; Lu, Wei; Chen, Yan; Dong, Zheng; Bai, Wenlin; Yoshida, Eric M; Mendez-Sanchez, Nahum; Hu, Ke-Qin; Qi, Xingshun; Yang, Yongping
• Is Part Of: Journal of infectious diseases. Volume 225:Number 6(2022)
• Page Start: 1091
• Page End: 1099
• Publication Date: 2020-05-21
• Subjects: hepatitis B -- liver fibrosis -- liver cirrhosis -- entecavir -- traditional Chinese medicine; Communicable diseases -- Periodicals; Diseases -- Causes and theories of causation -- Periodicals; Medicine -- Periodicals; Communicable Diseases -- Periodicals; Electronic journals; 616.9
• DOI: 10.1093/infdis/jiaa266
• Languages: English
• ISSNs: 0022-1899

Abstract

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. Abstract : In this multicenter randomized controlled trial of 1000 patients with chronic hepatitis B and advanced fibrosis or cirrhosis, Biejia-Ruangan as an add-on therapy to entecavir significantly increased rates of fibrosis regression and cirrhosis reversal.