Efficacy and safety of Fuzheng Huayu tablet on persistent advanced liver fibrosis following 2 years entecavir treatment: A single arm clinical objective performance criteria trial.

Abstract

ETHNOPHARMACOLOGICAL RELEVANCE:

Antiviral therapy can alleviate liver fibrosis in chronic hepatitis B, but it has a limited effect on advanced liver fibrosis/cirrhosis. Traditional Chinese medicine (TCM), particularly FuZheng HuaYu (FZHY) tablet, appears to have an antifibrotic effect, but its improving resolution of hepatitis b virus (HBV) -associated advanced fibrosis and experienced anti-viral treatment has not been investigated.

AIM OF THE STUDY:

To observe the safety and efficacy of adjunctive FZHY on the HBV-associated cirrhosis patients who received 2 years of entecavir but still with advanced fibrosis.

METHODS:

An open-label, multicentre, single arm trial. 251 patients were included and treated with TCM consisted of FZHY tablets 1.6 g and granules, three times a day in addition to entecavir 0.5 mg daily for an additional 48 weeks. Primary outcome was regression of fibrosis (the proportion of patients with a 1-point decrease in the Ishak liver fibrosis score from baseline to week 48).

RESULTS:

Fibrosis regression occurred in 94 of 184 patients with paired liver biopsy (51.09%, 95% CI: 43.9～58.0). In 132 compensated cirrhosis patients (Ishak score ≥5), 56.06% (74/132, 95% CI: 47.5～64.2) showed fibrosis regression and reached the goal of 54% (15% more than entecavir mono-therapy). 10 patients occurred adverse reaction, most of them were mild, and all recovered or achieved remission.

CONCLUSIONS:

The combination therapy of FZHY, TCM granules and ETV could regress the liver fibrosis in the patients with HBV cirrhosis, who experienced 2 years of ETV treatment, and it is safe and well tolerated.

• Authors: Zhi-Min Zhao, Chuan-Wu Zhu, Jia-Quan Huang, Xiao-Dong Li, Yu-Xi Zhang, Jian Liang, Wei Zhang, Yong Zhang, Xian-Gao Jiang, Ya-Li Zong, Ke-Jun Zhang, Ke-Wei Sun, Biao Zhang, Yun-Hai Lv, Hui-Chun Xing, Qing Xie, Ping Liu, Cheng-Hai Liu
• Journal: Journal of ethnopharmacology (J Ethnopharmacol) Vol. 298 Pg. 115599 (Nov 15 2022) ISSN: 1872-7573 [Electronic] Ireland
• PMID: 35932973 (Publication Type: Journal Article)
• Copyright: Copyright © 2022 The Authors. Published by Elsevier B.V. All rights reserved.

Chemical References

• Antiviral Agents
• Drugs, Chinese Herbal
• Tablets
• fuzheng huayu
• entecavir
• Guanine

Topics

• Antiviral Agents (adverse effects)
• Drugs, Chinese Herbal
• Guanine (adverse effects, analogs & derivatives)
• Hepatitis B virus
• Hepatitis B, Chronic (drug therapy)
• Humans
• Liver Cirrhosis (drug therapy, pathology)
• Tablets
• Treatment Outcome