Entecavir combining Chinese herbal medicine for HBeAg-positive chronic hepatitis B patients: a randomized, controlled trial
Authors: Li, Xiaoke; Zhou, Daqiao; Chi, Xiaoling; Li, Qin; Wang, Li; Lu, Bingjiu; Mao, Dewen; Wu, Qikai; Wang, Xianbo; Zhang, Mingxiang; Xue, Jingdong; Li, Yong; Lu, Wei; Guo, Jianchun; Jiang, Feng; Zhang, Xinwei; Li, Zhiguo; Yang, Xianzhao; Guo, Hui; Gan, Danan; He, Liyun; Luo, Lin; Zhang, Ludan; Du, Hongbo; Ye, Yong'an
Background and aim Traditional Chinese medicine (TCM) is widely accepted and prescribed in China alongside Nucleoside analogs (NAs). In this double-blind, placebo-controlled, randomized, multi-center trial, we evaluated whether entecavir (ETV) plus TCM formulas Tiao-Gan-Yi-Pi granule (TGYP) and Tiao-Gan-Jian-Pi-Jie-Du granule (TGJPJD) increase the rate of hepatitis B e antigen (HBeAg) loss in Chinese patients. Methods 596 eligible participants were randomly assigned, in a 1:1 ratio, to two study groups in this 108-week trial: The experiment group was assigned ETV plus the TCM formula. The control group was assigned ETV plus a TCM placebo. We compared the rate of HBeAg loss by the end of week 108 between the two arms as the primary outcome. Secondary outcomes included hepatitis B surface antigen (HBsAg) level, proportion of undetectable HBV-DNA, and liver enzymes (ALT, AST, GGT) at week 108. Results The combination therapy achieved superior HBeAg loss at 108 weeks, without additional adverse events. The rate of HBeAg loss at week 108 was 37.54% (95% CI 31.9-43.2%) in the experiment group and 27.21% (95% CI 22.0-32.4%) in the control group. There was a statistically significant difference between the two arms of 10.33% (95% CI 8.4-12.3%, p = 0.008). The DNA loss rate, serum HBsAg level, and liver enzymes were similar between the groups by the end of 108th week. Conclusion Combining the Chinese herbal formula with ETV therapy demonstrated superior HBeAg clearance compared with ETV monotherapy. This finding indicates that this combined therapy could produce an improved therapeutic effect and safety profile.
Clinical characteristics of chronic hepatitis B cured by peginterferon in combination with nucleotide analogs
INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES
Authors: Bao, Xuli; Guo, Jia; Xiong, Fang; Qu, Yachao; Gao, Yao; Gu, Na; Lu, Jun
Objectives: The purpose of this study was to analyze the clinical characteristics of chronic hepatitis B (CHB) cured by antiviral therapy. Methods: Forty-two patients with CHB were enrolled. All patients had been treated with peginterferon (Peg-IFN) in combination with nucleoside analogue (NA) therapy for variable amounts of time, and all had been successfully cured of the disease. Results: The combined treatment time for all participants was 124.7 +/- 58.8 weeks, and the average Peg-IFN treatment time was 102.6 +/- 56.1 weeks. At 24 weeks, Hepatitis B surface antigen (HBsAg) and Hepatitis B e antigen (HBeAg) had decreased more than 50% from baseline. Multivariate logistic regression analysis of the week 96 HBsAg-clearing group and the non-HBsAg-clearing group showed a statistically significant difference in baseline HBV DNA levels and week 48 HBsAg levels. Those which baseline HBV DNA was < 2.75 log(10) IU/mL, and week 48 HBsAg levels were < 0.88 log(10) IU/mL were more likely to achieve rapid HBsAg clearance at 96 weeks. This suggests that low levels of baseline HBV DNA and week 48 HBsAg are a predictor of rapid HBsAg clearance at 96 weeks. Conclusions: Individualized extension of combination therapy to more than 96 weeks depending on the patient's response and adverse reaction conditions can help achieve a clinical cure. Patients with low baseline HBV DNA and low HBsAg levels at 48 weeks achieve HBsAg clearance more quickly than other populations. (C) 2020 The Author(s). Published by Elsevier Ltd on behalf of International Society for Infectious Diseases.