Abstract

Aim Fuzhenghuayu (FZHY) capsule can inhibit the progression of cirrhosis. This study explored whether FZHY can reduce the incidence of hepatocellular carcinoma (HCC) in patients with hepatitis B-caused cirrhosis (HBC) undergoing antiviral therapy. Methods A retrospective review of 842 patients with HBC between 2011 and 2015 was performed, including 270 treated with FZHY combined with nucleos (t) ide analogues (NAs) and 572 with NAs alone. The incidence of HCC was compared between the FZHY (n = 259) and control (n = 259) groups using 1 : 1 propensity score (PS) matching. The incidence of HCC in patients with HBC with different Child-Turcotte-Pugh (CTP) classifications and Toronto HCC risk index (THRI) scores was analyzed using Kaplan–Meier curves. Results The 5-year cumulative incidence of HCC before and after PS matching was 151 (17.9%) and 86 (16.6%), respectively. In PS-matched samples, the multivariate Cox proportional-hazards model indicated that the FZHY group demonstrated a significantly lower risk for HCC than the control group (adjusted hazard ratio [aHR] = 0.32, 95% CI 0.19–0.53 P < 0.001). The risk of HCC diminished with increased duration of FZHY use. The stratified analysis revealed that the FZHY group, regardless of CTP classification, benefited significantly from FZHY therapy. Patients in the medium- and high-THRI risk groups were the dominant population for FZHY. Conclusions FZHY combined with NAs was associated with a significantly lower risk of HCC than NAs alone in patients with HBC, which supports the integration of FZHY with antiviral treatment into clinical practice.

Highlights

  • Cirrhosis is the most significant risk factor for the development of hepatocellular carcinoma (HCC). e 5-year cumulative incidence of HCC in patients with hepatitis B virus-caused cirrhosis (HBC) has been reported to be 17% in East Asia and 10% in Western countries [1]. e risk of HCC development in patients infected with hepatitis B virus is 10to 100-fold greater than in uninfected individuals [2]

  • Cirrhosis is a premalignant state with an increased risk for HCC over time [20]. e fibrotic burden is becoming one of the most important factors related to HCC in patients with HBC, especially in those with sustained low viral status [21]

  • Accumulating evidence has indicated that FZHY combined with antiviral therapy yields better effects in treating HBV-related cirrhosis, with no serious adverse events [22]

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Summary

Introduction

Cirrhosis is the most significant risk factor for the development of hepatocellular carcinoma (HCC). e 5-year cumulative incidence of HCC in patients with hepatitis B virus-caused cirrhosis (HBC) has been reported to be 17% in East Asia and 10% in Western countries [1]. e risk of HCC development in patients infected with hepatitis B virus is 10to 100-fold greater than in uninfected individuals [2]. E 5-year cumulative incidence of HCC in patients with hepatitis B virus-caused cirrhosis (HBC) has been reported to be 17% in East Asia and 10% in Western countries [1]. E risk of HCC development in patients infected with hepatitis B virus is 10to 100-fold greater than in uninfected individuals [2]. Studies comparing ETV or TDF with older NAs did not observe a difference in HCC risk reduction between the agents [7, 8]. Studies have found that patients treated with ETV remain at considerable risk for developing HCC despite long-term viral suppression [9]. Some studies reported that the annual incidence of HCC ranges from 0.9% to 5.4% in patients with HBC treated with ETV or TDF [10]. Some studies reported that the annual incidence of HCC ranges from 0.9% to 5.4% in patients with HBC treated with ETV or TDF [10]. ese data

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