Li S-Y, Li H, Xiong Y-L, Liu F, Peng M-L, Zhang D-Z, Ren H, Hu P
Key Laboratory of Molecular Biology for Infectious Diseases (Ministry of Education), Institute for Viral Hepatitis, Department of Infectious Diseases, The Second Affiliated Hospital, Chongqing Medical University, Chongqing, China.
J Viral Hepat. 2017 Nov;24 Suppl 1:12-20. doi: 10.1111/jvh.12755.
At present, the long-term effects of pegylated interferon-α (PEG-IFN-α) and entecavir (ETV) are controversial. Studies directly compared the long-term outcomes of these two drugs have not been completed. This study was designed to compare the clinical outcomes of PEG-IFN-α vs ETV therapy in Chinese patients with chronic HBV infection. From September 2008 to December 2016, a large, observational, open-label, prospective cohort study of HBeAg-positive patients with CHB who received PEG-IFN-α or ETV therapy was carried out at the Second Affiliated Hospital of Chongqing Medical University. Cumulative incidences of unfavourable events were calculated with respect to treatment type. Based on the REACH-B model, we compared the observed incidence of hepatocellular carcinoma (HCC) with the expected incidence in each group. PEG-IFN-α-treated patients showed a lower cumulative incidences of unfavourable events and cirrhosis than those treated with ETV (P = .031; P = .044, respectively). Impact factor exploration indicated that treatment type and platelet count are significantly associated with the occurrence of unfavourable events. Based on the REACH-B model, a lower observed cumulative incidence of HCC was observed in PEG-IFN-α-treated patients than predicted (P = .038). However, there was no significant difference of the cumulative HCC incidence between the observed and the predicted cases for ETV-experienced patients (P = .36). Treatment with PEG-INF-α leads to a lower incidence of unfavourable events including cirrhosis and HCC than ETV in patients with HBV. Treatment type and baseline platelet count may be two important factors associated with the long-term clinical outcomes of patients with CHB.
目前,聚乙二醇化干扰素-α(PEG-IFN-α)和恩替卡韦(ETV)的长期疗效存在争议。直接比较这两种药物长期疗效的研究尚未完成。本研究旨在比较PEG-IFN-α与ETV治疗中国慢性乙型肝炎病毒(HBV)感染患者的临床疗效。2008年9月至2016年12月,重庆医科大学附属第二医院对接受PEG-IFN-α或ETV治疗的HBeAg阳性慢性乙型肝炎(CHB)患者进行了一项大型、观察性、开放标签的前瞻性队列研究。计算了不同治疗类型的不良事件累积发生率。基于REACH-B模型,我们比较了每组中观察到的肝细胞癌(HCC)发生率与预期发生率。与接受ETV治疗的患者相比,接受PEG-IFN-α治疗的患者不良事件和肝硬化的累积发生率更低(分别为P = 0.031;P = 0.044)。影响因素探索表明,治疗类型和血小板计数与不良事件的发生显著相关。基于REACH-B模型,接受PEG-IFN-α治疗的患者观察到的HCC累积发生率低于预测值(P = 0.038)。然而,接受ETV治疗的患者观察到的与预测的HCC累积发生率之间没有显著差异(P = 0.36)。对于HBV患者,与ETV相比,使用PEG-INF-α治疗导致包括肝硬化和HCC在内的不良事件发生率更低。治疗类型和基线血小板计数可能是与CHB患者长期临床疗效相关的两个重要因素。