替诺福韦治疗慢性乙型肝炎的治疗效果和安全性：韩国现实

StephenW

PLoS One. 2017 Jan 23;12(1):e0170362. doi: 10.1371/journal.pone.0170362. eCollection 2017.
Treatment Efficacy and Safety of Tenofovir-Based Therapy in Chronic Hepatitis B: A Real Life Cohort Study in Korea.Ahn HJ1, Song MJ1, Jang JW1, Bae SH1, Choi JY1, Yoon SK1.
Author information

• 1Department of Internal Medicine, Division of Hepatology and Gastroenterology, College of Medicine, The Catholic University of Korea, Seoul, Korea.
  

AbstractBACKGROUND & AIMS: We evaluated the efficacy and safety of Tenofovir disoproxil fumarate (TDF)-based therapy in naïve and treatment-experienced chronic hepatitis B (CHB) patients for 96 weeks in Korean real life practice.
METHODS: A total of 209 CHB patients with a prescription for TDF at the Seoul and Daejeon St. Mary's hospitals were enrolled from December 2012 to October 2014. We compared the virological responses and evaluated the renal safety of treatment-naive and treatment-experienced patients.
RESULTS: An overall complete virological response (CVR) was achieved in 80.4% and 84.6% of patients at weeks 48 and 96, respectively. In a subgroup analysis, CVR at week 96 was present in 88.4%, 75.0%, 75.5%, and 83.3% of participants in the lamivudine-resistant (LAM-R) group, adefovir-resistant (ADV-R) group, multidrug-resistant (MDR) group, and suboptimal response group, respectively. In a multivariate analysis, ADV-R, MDR, hepatitis B virus DNA, and hepatitis B e antigen were independent predictors for CVR. With regard to renal safety, diabetes mellitus, cirrhosis, and an initial low estimated glomerular filtration rate were independent factors affecting creatinine elevation (≥0.5 mg/dL). Moreover, two patients with DM and cirrhosis experienced TDF-related Fanconi syndrome.
CONCLUSIONS: TDF-based therapy demonstrated sustained viral suppression and favorable safety during a 2-year treatment period. The LAM-R and suboptimal response groups showed comparable efficacy to the naïve group, while the ADV-R and MDR groups were significantly associated with a low CVR. Close monitoring of renal safety should be mandatory when treating CHB patients receiving TDF, particularly those with DM and cirrhosis.


PMID:28114428DOI:10.1371/journal.pone.0170362

StephenW

PLoS One。 2017 Jan 23; 12（1）：e0170362。 doi：10.1371 / journal.pone.0170362。 eCollection 2017。
替诺福韦治疗慢性乙型肝炎的治疗效果和安全性：韩国现实生活队列研究。
Ahn HJ1，Song MJ1，Jang JW1，Bae SH1，Choi JY1，Yoon SK1。
作者信息

    1韩国天主教大学医学院肝内科胃肠病学科内科，韩国首尔。

摘要
背景与目的：

我们在韩国现实生活实践中评估了替诺福韦地索普西富马酸盐（TDF）为基础的治疗在天真和治疗经历的慢性乙型肝炎（CHB）患者96周的疗效和安全性。
方法：

在2012年12月至2014年10月，共有209名在首尔和大田圣玛丽医院接受TDF处方的CHB患者入组。我们比较了病毒学应答并评估了未接受治疗和接受治疗的患者的肾脏安全性。
结果：

在第48周和第96周分别在80.4％和84.6％的患者中实现了完全病毒学应答（CVR）。在亚组分析中，96周时的CVR分别存在于拉米夫定耐药（LAM-R）组，阿德福韦耐药（ADV-R）组，多药耐药组（ADV-R）组的88.4％，75.0％，75.5％和83.3％耐药（MDR）组和次优反应组。在多变量分析中，ADV-R，MDR，乙型肝炎病毒DNA和乙型肝炎e抗原是CVR的独立预测因子。关于肾脏安全性，糖尿病，肝硬化和初始低估计肾小球滤过率是影响肌酐升高（≥0.5mg/ dL）的独立因素。此外，两名DM和肝硬化患者经历TDF相关的Fanconi综合征。
结论：

基于TDF的治疗显示在2年治疗期间持续的病毒抑制和有利的安全性。 LAM-R和次优反应组显示与初始组相当的效力，而ADV-R和MDR组与低CVR显着相关。当治疗接受TDF的CHB患者，特别是患有DM和肝硬化的CHB患者时，应当严格监测肾脏的安全性。

PMID：
    28114428
DOI：
    10.1371 / journal.pone.0170362