TDF与HBV患者肝癌风险降低有关 数据是否足以证明从恩替卡韦

StephenW

TDF Linked with Lower Risk of Liver Cancer in HBV Patients            Is the data enough to justify switch from entecavir to tenofovir treatment?                                                                                                                                                                       

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•                                   by Molly Walker, Staff Writer, MedPage Today  April 14, 2019
•                                     This article is a collaboration between MedPage Today® and:
                                      
  

                                                                                 
                                VIENNA -- Patients in Hong Kong with chronic hepatitis B virus (HBV) infection were less likely to develop hepatocellular carcinoma (HCC) with tenofovir disoproxil fumarate (TDF) therapy compared with entecavir (ETV), a researcher said here.
Compared with ETV (Baraclude) treatment, TDF (Viread and Vemlidy) treatment was linked with a lower risk of HCC (adjusted subdistribution HR 0.32, 95% CI 0.16-0.65), reported Terry Cheuk Fung Yip, PhD, of The Chinese University in Hong Kong, at the European Association for the Study of the Liver(EASL) annual meeting.
This late-breaking trial was the second one presented at EASL to discover this association. "A very interesting study was presented by a Korean group suggested that TDF-treated patients have a lower risk of developing HCC than those who receive ETV. This raises the question about whether TDF and ETV would have a similar or different risk reduction," Yip said at an EASL press conference.
Yip's group examined inpatient and outpatient data over a 10-year period from all Hong Kong public hospitals and clinics. Missing data were replaced by multiple imputation, and then propensity score weighting was used to balance clinical characteristics between two treatment groups, the authors said.
Overall, 29,350 patients were identified (mean age about 53l; about two-thirds men). However, more than 95% first received entecavir versus tenofovir disoproxil fumarate for chronic HBV infection. At a median of 6 years follow-up, eight patients (0.6%) on TDF developed HCC compared to 1,386 (4.9%) of patients on ETV.
The 5-year cumulative incidence of HCC was 7.0% (95% CI 6.6-7.3) in the ETV group versus 1.1% (95% CI 0.5-2.3). This association remained robust in the propensity score weighting analysis, the authors noted (adjusted SHR 0.36, 95% CI 0.16-0.80, P=0.013).
MedPage Today asked EASL press conference moderator Francesco Negro, MD, of the University Hospital of Geneva, if he would switch his patients from ETV to TDF, Negro responded with caution.
"It's a challenging question, because we now have two sets of data suggesting this [difference with TDF]. I do not know the answer to this question; it is too early," he said.
Gregory Dore, MBBS, PhD, of the University of New South Wales in Sydney was not involved in the study, but chimed in with some caveats.
"A very small portion of patients were on tenofovir, and they were presumably at different income levels than patients on entecavir," he said. "There may also be other factors that were not tested for in the propensity score analysis -- alcohol intake, for example, is an important risk factor, and there are many other factors that need to be further explored."
Yip cited a late-breaker EASLposter presentation from Stuart C. Gordon, MD, of Henry Ford Hospital in Detroit, and colleagues that found that the risk of HCC for patients treated with TDF versus ETV may vary by race group. Specifically, Gordon's group found a trend towards risk reduction in Asian patients, consistent with both the Korean study and the findings from Yip's group.
Yip said the differences could be due to immunology or perhaps the reason is more virological, where "TDF can perhaps clear the virus more rapidly."
Currently, ETV and TDF are equally recommended as first-line treatments for chronic HBV, the authors noted. Negro added that "I don't think we're ready to include this data in the guidelines, but we will be following the data very, very carefully."

StephenW

TDF与HBV患者肝癌风险降低有关
数据是否足以证明从恩替卡韦转为替诺福韦治疗的合理性？

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    作者：Molly Walker，撰稿人，MedPage Today
    2019年4月14日

    本文是MedPageToday®与Medpage Today的合作

维也纳 - 一名研究人员表示，与恩替卡韦（ETV）治疗相比，香港患有慢性乙型肝炎病毒（HBV）感染的患者发生肝细胞癌（HCC）的可能性较低，而替诺福韦地索普西富马酸盐（TDF）治疗。

与ETV（Baraclude）治疗相比，TDF（Viread和Vemlidy）治疗与较低的HCC风险相关（调整后的分配HR 0.32,95％CI 0.16-0.65），中国大学的Terry Cheuk Fung Yip博士报道。香港，在欧洲肝脏研究协会（EASL）年会上。

这个最新的试验是在EASL上发现的第二个发现这种关联的试验。 “一项韩国研究小组提出的一项非常有趣的研究表明，TDF治疗的患者发生HCC的风险低于接受ETV的患者。这就提出了TDF和ETV是否会有相似或不同的风险降低的问题，”Yip在EASL新闻发布会上说。

叶氏集团在所有香港公立医院和诊所检查了10年内的住院和门诊数据。作者说，缺失的数据被多重插补所取代，然后倾向评分加权用于平衡两个治疗组之间的临床特征。

总体而言，确定了29,350名患者（平均年龄约53l;约三分之二的男性）。然而，超过95％首先接受恩替卡韦与替诺福韦地索普西富马酸盐治疗慢性HBV感染。随访中位数为6年，TDF患者中有8例（0.6％）发生HCC，而ETV患者为1,386例（4.9％）。

ETV组的5年累积HCC发生率为7.0％（95％CI 6.6-7.3），而1.1％（95％CI 0.5-2.3）。作者指出，这种关联在倾向评分加权分析中保持稳健（调整后的SHR为0.36,95％CI为0.16-0.80，P = 0.013）。

MedPage Today要求日内瓦大学医院的EASL新闻发布会主持人Francesco Negro博士，如果他将患者从ETV转为TDF，Negro谨慎回应。

“这是一个具有挑战性的问题，因为我们现在有两组数据表明这与[TDF的差异]。我不知道这个问题的答案;现在还为时过早，”他说。

悉尼新南威尔士大学的MBBS博士格雷戈里多尔没有参与这项研究，但他提出了一些警告。

“很少一部分患者服用替诺福韦，他们的收入水平可能与恩替卡韦患者不同，”他说。 “在倾向评分分析中可能还有其他因素尚未测试 - 例如，酒精摄入量是一个重要的风险因素，还有许多其他因素需要进一步探索。”

叶先生引用底特律亨利福特医院的Stuart C. Gordon博士的一篇晚期破坏性EASL海报展示，同事们发现，TDF治疗患者与ETV患者的HCC风险可能因种族而异。具体而言，Gordon的研究小组发现了亚洲患者降低风险的趋势，这与韩国研究和叶氏研究小组的研究结果一致。

叶先生表示，这种差异可能是由于免疫学原因，或者原因可能更具病毒学原因，“TDF可能更快地清除病毒”。

作者指出，目前，ETV和TDF同样被推荐为慢性HBV的一线治疗药物。黑人补充说：“我认为我们不准备将这些数据纳入指南，但我们将非常谨慎地关注这些数据。”

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宁可信其有，不可信其无。因为我们付不起这个学费