替诺福韦在慢性乙型肝炎的功效和安全性：澳大利亚现实世

StephenW

World J Hepatol. 2017 Jan 8;9(1):48-56. doi: 10.4254/wjh.v9.i1.48.
Efficacy and safety of tenofovir in chronic hepatitis B: Australian real world experience.Lovett GC1, Nguyen T1, Iser DM1, Holmes JA1, Chen R1, Demediuk B1, Shaw G1, Bell SJ1, Desmond PV1, Thompson AJ1.
Author information

• 1Grace C Lovett, Tin Nguyen, David M Iser, Jacinta A Holmes, Robert Chen, Barbara Demediuk, Gideon Shaw, Sally J Bell, Paul V Desmond, Alexander J Thompson, Department of Gastroenterology, St Vincent's Hospital Melbourne, Fitzroy 3065, Australia.
  

AbstractAIM: To evaluate the long-term treatment outcomes of tenofovir therapy in patients in a real world Australian tertiary care setting.
METHODS: We performed a retrospective analysis of treatment outcomes among treatment-naïve and treatment-experienced patients receiving a minimum 3 mo tenofovir therapy through St Vincent's Hospital Melbourne, Australia. We included patients receiving tenofovir [tenofovir disoproxil fumarate (TDF)] monotherapy, as well as patients treated with TDF in combination with a second antiviral agent. Patients were excluded if they demonstrated human immune-deficiency virus/hepatitis C virus/hepatitis delta virus coinfection or were less than 18 years of age. We considered virological and biochemical response, as well as safety outcomes. Virological response was determined by measurement of hepatitis B virus (HBV) DNA using sensitive assays; biochemical response was determined via serum liver function tests; histological response was determined from liver biopsy and fibroscan; safety analysis focused on glomerular renal function and bone mineral density. The primary efficacy endpoint was complete virological suppression over time, defined by HBV DNA < 20 IU/mL. Secondary efficacy endpoints included rates of biochemical response, and HB e antigen (HBeAg)/HB surface antigen loss and seroconversion over time.
RESULTS: Ninety-two patients were identified who fulfilled the enrolment criteria. Median follow-up was 26 mo (range 3-114). Mean age was 46 (24-78) years, 64 (70%) were male and 77 (84%) were of Asian origin. 55 (60%) patients were treatment-naïve and 62 patients (67%) were HBeAg-negative. Complete virological suppression was achieved by 45/65 (71%) patients at 12 mo, 37/46 (80%) at 24 mo and 25/28 (89%) at 36 mo. Partial virological response (HBV DNA 20-2000 IU/mL) was achieved by 89/92 (96.7%) of patients. Multivariate analysis showed a significant relationship between virological suppression at end of follow-up and baseline HBV DNA level (OR = 0.897, 95%CI: 0.833-0.967, P = 0.0046) and HBeAg positive status (OR = 0.373, 95%CI: 0.183-0.762, P = 0.0069). There was no difference in response comparing treatment-naïve and treatment-experienced patients. Three episodes of virological breakthrough occurred in the setting of non-compliance. Tenofovir therapy was well tolerated.
CONCLUSION: Tenofovir is an efficacious, safe and well-tolerated treatment in an Australian real-world tertiary care setting. Our data are similar to the reported experience from registration trials.


KEYWORDS: Australia; Chronic hepatitis B; Hepatitis B virus; Real-life; Tenofovir; Virological suppression

PMID:28105258DOI:10.4254/wjh.v9.i1.48

StephenW

世界J Hepatol。 2017 Jan 8; 9（1）：48-56。 doi：10.4254 / wjh.v9.i1.48。
替诺福韦在慢性乙型肝炎的功效和安全性：澳大利亚现实世界经验。
Lovett GC1，Nguyen T1，Iser DM1，Holmes JA1，Chen R1，Demediuk B1，Shaw G1，Bell SJ1，Desmond PV1，Thompson AJ1。
作者信息

    1 Grace C Lovett，Tin Nguyen，David M Iser，Jacinta A Holmes，Robert Chen，Barbara Demediuk，Gideon Shaw，Sally J Bell，Paul V Desmond，Alexander J Thompson，Department of Gastroenterology，St Vincent's Hospital Melbourne，Fitzroy 3065，Australia。

摘要
目标：

评估替诺福韦治疗在真实世界澳大利亚三级医疗机构的患者的长期治疗结果。
方法：

我们对澳大利亚墨尔本St Vincent医院接受最少3 mo替诺福韦治疗的未接受治疗和接受治疗的患者的治疗结果进行回顾性分析。我们包括接受替诺福韦（替诺福韦酯）（富马酸替诺福韦（TDF）]单一疗法的患者，以及接受TDF联合第二种抗病毒药物治疗的患者。如果患者证明人免疫缺陷病毒/丙型肝炎病毒/丁型肝炎病毒合并感染或小于18岁，则被排除。我们考虑了病毒学和生化反应，以及安全结果。通过使用敏感测定法测量乙型肝炎病毒（HBV）DNA来确定病毒学应答;通过血清肝功能检测确定生化反应;从肝活组织检查和纤维组织确定组织学反应;安全性分析侧重于肾小球肾功能和骨矿物质密度。主要功效终点是随时间的完全病毒学抑制，由HBV DNA <20IU / mL定义。次要功效终点包括生化反应速率，HBe抗原（HBeAg）/ HB表面抗原损失和血清转换随时间的变化。
结果：

鉴定出92名患者符合入选标准。中位随访26 mo（范围3-114）。平均年龄为46岁（24-78岁），64（70％）是男性，77（84％）是亚洲裔。 55例（60％）患者为初次治疗，62例（67％）为HBeAg阴性。通过在12个月时的45/65（71％）患者，在24个月时的37/46（80％）和在36个月时的25/28（89％）实现完全的病毒抑制。部分病毒学应答（HBV DNA 20-2000IU / mL）由89/92（96.7％）患者实现。多变量分析显示随访结束时病毒学抑制与基线HBV DNA水平（OR = 0.897,95％CI：0.833-0.967，P = 0.0046）和HBeAg阳性状态（OR = 0.373,95％CI： 0.183-0.762，P = 0.0069）。与未接受治疗和经历过治疗的患者相比，反应没有差异。在不合规的情况下发生了三次病毒学突破。替诺福韦治疗耐受性良好。
结论：

替诺福韦是在澳大利亚现实世界的三级医疗环境中有效，安全和良好耐受的治疗。我们的数据类似于报告的注册试验的经验。
关键词：

澳大利亚;慢性乙型肝炎;乙型肝炎病毒;现实生活;替诺福韦;病毒抑制

PMID：
    28105258
DOI：
    10.4254 / wjh.v9.i1.48

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