No information is available regarding the influence of besifovir (BSV), a new nucleotide analogue, on the occurrence of hepatocellular carcinoma (HCC) in patients with chronic hepatitis B (CHB). This study evaluated the reduced risk of HCC in patients undergoing BSV treatment. A total of 188 patients with CHB were treated with BSV for up to 8 years. We prospectively assessed the incidence of HCC compared with the risk from prediction models. During the follow-up, 5 patients developed HCC: 1 of 139 patients with non-cirrhotic CHB, and 4 of 49 patients with liver cirrhosis. We compared the HCC incidence in non-cirrhotic and cirrhotic patients with the predicted number derived from the REACH-B (risk estimation for HCC in CHB) model and GAG-HCC (guide with age, gender, HBV DNA, core promotor mutation, and cirrhosis) model, respectively. The standardized incidence ratio (SIR) was 0.128 (p= 0.039) at 7 years in non-cirrhotic CHB patients, and the SIR was 0.371 (p= 0.047) at 7.5 years in cirrhotic patients, suggesting a significantly decreased HCC incidence in both groups. HCC prediction was available for BSV-treated patients using existing models. In conclusion, BSV decreased the risk of HCC in patients with CHB, and prediction models were applicable. Clinical trial registry website and trial number: ClinicalTrials.gov no: NCT01937806.
目前尚无关于新型核苷类似物贝西福韦(BSV)对慢性乙型肝炎(CHB)患者肝细胞癌(HCC)发生风险影响的相关信息。本研究评估了接受BSV治疗患者HCC风险的降低情况。共188例CHB患者接受BSV治疗长达8年。我们通过前瞻性研究,将实际HCC发生率与预测模型的风险评估进行比较。随访期间,5例患者发生HCC:其中139例非肝硬化CHB患者中1例发病,49例肝硬化患者中4例发病。我们分别采用REACH-B(慢性乙型肝炎肝细胞癌风险预测)模型和GAG-HCC(基于年龄、性别、HBV DNA、核心启动子突变及肝硬化的指导)模型,将非肝硬化与肝硬化患者的实际HCC发生率与模型预测值进行对比。结果显示:非肝硬化CHB患者7年标准化发病率比(SIR)为0.128(p=0.039),肝硬化患者7.5年SIR为0.371(p=0.047),表明两组患者的HCC发生率均显著降低。现有预测模型适用于BSV治疗患者的HCC风险评估。综上所述,BSV可降低CHB患者的HCC风险,且现有预测模型具有适用性。临床试验注册网站及编号:ClinicalTrials.gov,编号NCT01937806。