1. Entecavir plus Biejia-Ruangan compound reduces the risk of hepatocellular carcinoma in Chinese patients with chronic hepatitis B.
- Author
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Ji, Dong, Chen, Yan, Bi, Jingfeng, Shang, Qinghua, Liu, Huabao, Wang, Jia-Bo, Tan, Lin, Wang, Jing, Chen, Yongping, Li, Qin, Long, Qinghua, Song, Laicheng, Jiang, Li, Xiao, Guangming, Yu, Zujiang, Chen, Liang, Wang, Xiaodong, Chen, Da, Li, Zhiqin, and Dong, Zheng
- Subjects
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CHRONIC hepatitis B , *HEPATITIS B , *CHINESE people , *HEPATOCELLULAR carcinoma , *HEPATIC fibrosis , *CHINESE medicine - Abstract
Chronic hepatitis B (CHB) and liver fibrosis are associated with a high risk of hepatocellular carcinoma (HCC) development. We assessed whether entecavir (ETV) plus Biejia-Ruangan compound (BRC), an anti-fibrotic traditional Chinese medicine, can further reduce the risk of HCC in treatment-naïve Chinese patients with CHB and an Ishak fibrosis score of ≥3 points derived from our parent double-blind randomized placebo-controlled trial. After a 72-week comparison between ETV+BRC and ETV+placebo treatment, participants were eligible to enter an open-label treatment phase and were followed up every 6 months. The primary [secondary] endpoints were the incidence of HCC [liver-related deaths, non-HCC events, and non-liver-related deaths]. Modified intention-to-treat (mITT), intention-to-treat (ITT), and per-protocol (PP) populations were defined for the time-to-event analysis. A total of 1,000 patients were recruited; the median age was 42.0 years; 69.9% were male and 58.3% were HBeAg positive. In the mITT population, the 7-year cumulative incidence of HCC [liver-related deaths] was 4.7% [0.2%] for ETV+BRC, which was significantly lower than 9.3% [2.2%] for ETV monotherapy (p = 0.008 [ p = 0.030]). Notably, ETV+BRC treatment yielded a lower incidence of HCC in those who did not achieve regression of fibrosis at week 72 than ETV monotherapy (p = 0.018). There were no differences in the other 2 secondary endpoints or safety profiles between the groups. Multivariable Cox proportional regression analysis, including the treatment allocation as a parameter, also demonstrated that ETV+BRC treatment was associated with a reduced incidence of HCC. The ITT and PP analyses showed consistent results. ETV plus BRC combination treatment could further reduce the risk of HCC and liver-related deaths in patients with CHB and advanced fibrosis or cirrhosis, which may have important clinical implications for HCC prevention. Patients with chronic hepatitis B virus infection are at an increased risk of developing liver cancer (specifically hepatocellular carcinoma [HCC]). While there are effective antiviral treatments that can suppress the virus in chronically infected patients, the risk of HCC remains. Herein, we show that adding a traditional Chinese medicine called Biejia-Ruangan compound to an antiviral reduced the risk of HCC in patients with chronic hepatitis B. [Display omitted] • This RCT-based prospective cohort study included 1,000 patients and lasted for 7 years. • Compared with ETV treatment, the combination of ETV + Biejia-Ruangan compound could further reduce the incidence of HCC. • Biejia-Ruangan compound in addition to ETV should be considered for patients with CHB and advanced fibrosis or cirrhosis. [ABSTRACT FROM AUTHOR]
- Published
- 2022
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