高加索慢性乙型肝炎患者长期恩替卡韦或替诺福韦治疗期间

StephenW

Similar risk of hepatocellular carcinoma during long-term entecavir or tenofovir therapy in Caucasian patients with chronic hepatitis B
George V. Papatheodoridis
    George N. Dalekos
    Ramazan Idilman
    Harry L.A. Janssen
    Thomas Berg
    Pietro Lampertico
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Published:June 15, 2020DOI:https://doi.org/10.1016/j.jhep.2020.06.011
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Highlights

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    Caucasians with chronic hepatitis B treated with entecavir vs. tenofovir had:
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    Similar rates of hepatocellular carcinoma up to 12 years
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    Similar rates of biochemical/virological response, HBsAg loss and mortality
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    Less frequent elastographic reversion of cirrhosis at year 5

Background & Aims
A recent study in Asian patients with chronic hepatitis B (CHB) reported that the incidence of hepatocellular carcinoma (HCC) was lower in patients treated with tenofovir disoproxil fumarate (TDF) than entecavir (ETV), but this finding remains controversial. We aimed to identify any differences in HCC incidence, or other patient outcomes, between patients receiving TDF or ETV in the well monitored, multicenter European PAGE-B cohort.
Methods
We included 1,935 Caucasians with CHB, with or without compensated cirrhosis, treated with ETV (n = 772) or TDF (n = 1,163) monotherapy. Mean follow-up was 7.1 ± 3.0 years from ETV/TDF onset.
Results
The 5-year cumulative HCC incidence was 5.4% in ETV- and 6.0% in TDF-treated patients (log-rank, p = 0.321), with no significant difference in any patient subgroup (with or without cirrhosis, naïve or experienced to oral antiviral(s) [total, with or without cirrhosis]). In multivariable Cox regression analyses, the hazard of HCC was similar between ETV- and TDF-treated patients after adjustment for several HCC risk factors. ETV- and TDF-treated patients had similar rates of on-therapy biochemical and virological remission, HBsAg loss, liver transplantation and/or death. Elastographic reversion of cirrhosis at year 5 (liver stiffness <12 kPa) was observed in 245/347 (70.6%) patients with pretreatment cirrhosis, being more frequent in TDF- than ETV- treated patients (73.8% vs. 61.5%, p = 0.038).
Conclusion
In Caucasian patients with CHB, with or without cirrhosis, long-term ETV or TDF monotherapy is associated with similar HCC risk, rates of biochemical/virological remission, HBsAg loss and liver transplantation or death, but elastographic reversion of cirrhosis at year 5 was more frequent with TDF.
Lay summary
In a large cohort of Caucasians with chronic hepatitis B treated with entecavir (ETV) or tenofovir disoproxil fumarate (TDF) monotherapy, cumulative rates of hepatocellular carcinoma did not differ (up to 12 years). Nor did rates of biochemical/virological remission, HBsAg loss and liver transplantation or death. However, elastographic reversion of cirrhosis at year 5 was more frequent in TDF- than ETV-treated patients with pretreatment cirrhosis.

StephenW

高加索慢性乙型肝炎患者长期恩替卡韦或替诺福韦治疗期间肝细胞癌的风险相似

    乔治五世·帕帕特奥多里迪斯
    乔治·N·达莱科斯
    拉马赞·伊迪尔曼（Ramazan Idilman）
    哈里·詹森
    托马斯·伯格
    Pietro Lampertico
    显示所有作者

发布时间：2020年6月15日DOI：https：//doi.org/10.1016/j.jhep.2020.06.011
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强调

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    恩替卡韦与替诺福韦治疗的慢性乙型肝炎白种人：
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    长达12年的肝细胞癌发生率相似
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    生化/病毒反应，HBsAg丢失和死亡率的发生率相近
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    第5年肝硬化弹性成像复查率降低

背景与目标
一项针对亚洲慢性乙型肝炎（CHB）患者的最新研究报告说，替诺福韦酯富马酸酯（TDF）治疗的患者肝细胞癌（HCC）的发生率低于恩替卡韦（ETV），但这一发现仍存在争议。我们旨在确定在受到良好监控的多中心欧洲PAGE-B队列中接受TDF或ETV的患者之间HCC发生率或其他患者预后的任何差异。
方法
我们纳入了1935名患有CHB的白种人，无论是否患有代偿性肝硬化，均采用ETV（n = 772）或TDF（n = 1,163）单药治疗。从ETV / TDF发作开始，平均随访时间为7.1±3.0年。
结果
经ETV治疗的患者的5年累积HCC发生率为5.4％，经TDF治疗的患者的5年累积HCC发生率（log-rank，p = 0.321），在任何亚组（有或没有肝硬化，未接受过或未经口服的肝硬化）中均无显着差异抗病毒药物（总计，有或没有肝硬化））。在多变量Cox回归分析中，调整了几种HCC危险因素后，ETV和TDF治疗的患者的HCC危险相似。 ETV和TDF治疗的患者在治疗中的生化和病毒学缓解，HBsAg丢失，肝移植和/或死亡的发生率相似。在治疗前的肝硬化患者中，有245/347（70.6％）的患者在第5年出现肝硬化的弹性成像逆转（肝硬度<12 kPa），在TDF中比在ETV治疗的患者中更常见（73.8％vs. 61.5％，p = 0.038）。
结论
在患有或未患有肝硬化的高加索CHB患者中，长期ETV或TDF单一疗法与类似的HCC风险，生化/病毒学缓解率，HBsAg丢失和肝移植或死亡相关，但在5年时弹性成像恢复肝硬化的可能性更大。 TDF频繁使用。
放置摘要
在接受恩替卡韦（ETV）或替诺福韦富马酸替诺福韦（TDF）单药治疗的一大批慢性乙型肝炎高加索人中，肝细胞癌的累积发生率没有差异（长达12年）。生化/病毒学缓解，HBsAg丢失和肝移植或死亡的发生率也没有。然而，与ETV治疗的肝硬化患者相比，在TDF中5年级的肝硬化弹性成像逆转率更高。