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

Author:

Rong Guanghua1,Chen Yongping2,Yu Zujiang3,Li Qin4,Bi Jingfeng5,Tan Lin6,Xiang Dedong7,Shang Qinghua8,Lei Chunliang9,Chen Liang10,Hu Xiaoyu11,Wang Jing12,Liu Huabao13,Lu Wei14,Chen Yan1,Dong Zheng1,Bai Wenlin1,Yoshida Eric M15,Mendez-Sanchez Nahum16,Hu Ke-Qin17,Qi Xingshun18ORCID,Yang Yongping1

Affiliation:

1. Department of Liver Diseases & the Fifth Medical Center of the Chinese People’s Liberation Army General Hospital, Beijing, China

2. Department of Infectious and Liver Diseases, Liver Research Center, First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang Province, China

3. Department of Infectious Disease, First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China

4. Fuzhou Infectious Diseases Hospital, Fuzhou, Fujian Province, China

5. Department of Clinical and Translational Medicine, Fifth Medical Center of Chinese People’s Liberation Army General Hospital, Beijing, China

6. Liver Disease Department, Fuyang Second People’s Hospital, Fuyang, Anhui Province, China

7. Department of Infectious Diseases, Southwest Hospital, Third Military Medical University, Chongqing, China

8. Therapeutic Center for Liver Disease, 88th Hospital of People’s Liberation Army, Taian, Shandong Province, China

9. Guangzhou Eighth People’s Hospital, Guangzhou, Guangdong Province, China

10. Department of Hepatic Diseases, Shanghai Public Health Clinical Center, Shanghai, China

11. National Integrative Medicine Clinical Base for Infectious Diseases and Department of Infectious Diseases, Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan Province, China

12. Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University, Luzhou, Sichuan Province, China

13. Traditional Chinese Medicine Hospital of Chongqing, Chongqing, China

14. Tianjin Second People’s Hospital, Tianjin Institute of Hepatology, Tianjin, China

15. Division of Gastroenterology, Vancouver General Hospital, Vancouver, British Columbia, Canada

16. Liver Research Unit Medica Sur Clinic and Foundation, Faculty of Medicine, National Autonomous University of Mexico, Mexico City, Mexico

17. Division of Gastroenterology and Hepatology, School of Medicine, University of California, Irvine, Orange, California, USA

18. Department of Gastroenterology, General Hospital of Northern Theater Command (formerly General Hospital of Shenyang Military Area), Shenyang, Liaoning Province, China

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.

Funder

Major Science and Technology Special Project of China

Beijing Key Research Project of Special Clinical Application

Publisher

Oxford University Press (OUP)

Subject

Infectious Diseases,Immunology and Allergy

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