中国慢性乙型肝炎患者在现实世界临床实践中接受核苷/核苷酸类似物治疗的长期结局:来自EVOLVE研究的5年结果

IF 1.3 4区 医学 Q4 INFECTIOUS DISEASES Antiviral Therapy Pub Date : 2020-01-01 DOI:10.3851/IMP3372
Jidong Jia, Jia Shang, Hong Tang, Jiaji Jiang, Qin Ning, Xiaoguang Dou, Shuqin Zhang, Mingxiang Zhang, Tao Han, Deming Tan, Xinmin Zhou, Guoliang Chen, Jifang Sheng, Zhijun Su, Haijun Chen, Erhei Dai, Yinong Ye, Ying Guo, Yuefei Shen, Jing Yuan, Zhen Wei, Siyun Zhu
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引用次数: 2

摘要

背景:在中国,对慢性乙型肝炎病毒感染者(CHB)的最佳管理仍然是一个未满足的需求。EVOLVE研究是一项为期5年的前瞻性、纵向、观察性研究,比较了接受恩替卡韦(ETV)或拉米夫定(LAM)治疗的初治CHB患者的临床结果。方法:2012-2014年,从二线城市医院招募年龄≥18岁,诊断为慢性乙型肝炎的男性或女性,无论是否肝硬化或乙型肝炎e抗原(HBeAg)是否存在。初始治疗和后续治疗修改的选择由治疗医师自行决定。主要结局包括治疗修改、病毒学反应(HBV DNA)结果:在3408例入组患者中,分别有1807例和628例患者接受了ETV和lam治疗。平均年龄39.5岁,男性占74%,肝硬化占22.9%。lam组的治疗改进率高于ETV组(25.9%比13.7%);病毒突破在基于lam的组中是最常见的原因,而在ETV组中是经济原因。在第240周,两个治疗组的病毒学应答率均为73%。与基于lam的治疗相比,ETV的病毒突破发生率(12.6%比2.1%)和基因型耐药发生率(10.1%比1.2%;结论:这项真实世界的纵向研究表明,与基于lam的治疗相比,ETV治疗可显著降低hbv相关疾病进展、病毒突破和耐药性的风险。ClinicalTrials.gov NCT01726439。
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Long-term outcomes in Chinese patients with chronic hepatitis B receiving nucleoside/nucleotide analogue therapy in real-world clinical practice: 5-year results from the EVOLVE study.

Background: In China, the optimal management of individuals living with chronic HBV infection (CHB) remains an unmet need. The EVOLVE Study was a 5-year prospective, longitudinal, observational study that compared the clinical outcomes in treatment-naive CHB patients receiving entecavir (ETV) or lamivudine (LAM)-based therapies.

Methods: Males or females aged ≥18 years, diagnosed with CHB regardless of cirrhosis or hepatitis B e antigen (HBeAg) status were enrolled from tier 2 city hospitals (between 2012-2014). The choice of initial therapy and subsequent treatment modifications was at the discretion of treating physicians. Key outcomes included treatment modifications, virological response (HBV DNA <300 copies/ml) and HBV disease progression.

Results: Of the 3,408 patients enrolled, 1,807 and 628 received ETV and LAM-based therapy, respectively. The mean age was 39.5 years, 74% were male and 22.9% had cirrhosis. The rate of treatment modification was higher in the LAM-based versus ETV group (25.9% versus 13.7%); viral breakthrough was the most common reason in the LAM-based group versus financial reasons in the ETV group. At week 240, the virological response rate was 73% in both treatment groups. Compared with LAM-based therapy, ETV was associated with a significantly lower incidence of viral breakthrough (12.6% versus 2.1%) and genotypic resistance (10.1% versus 1.2%; P<0.0001 for both); significantly lower risk of HBV disease progression (14.0% versus 10.7%; P=0.0113); and lower rates of progression to decompensated cirrhosis (9.6% versus 6.4%) and hepatocellular carcinoma (1.9% versus 0.8%).

Conclusions: This real-world, longitudinal study demonstrated a significantly lower risk of HBV-related disease progression, viral breakthrough and resistance with ETV versus LAM-based therapy. ClinicalTrials.gov NCT01726439.

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来源期刊
Antiviral Therapy
Antiviral Therapy 医学-病毒学
CiteScore
2.60
自引率
8.30%
发文量
35
审稿时长
4-8 weeks
期刊介绍: Antiviral Therapy (an official publication of the International Society of Antiviral Research) is an international, peer-reviewed journal devoted to publishing articles on the clinical development and use of antiviral agents and vaccines, and the treatment of all viral diseases. Antiviral Therapy is one of the leading journals in virology and infectious diseases. The journal is comprehensive, and publishes articles concerning all clinical aspects of antiviral therapy. It features editorials, original research papers, specially commissioned review articles, letters and book reviews. The journal is aimed at physicians and specialists interested in clinical and basic research.
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