功效和替诺福韦的核苷安全（T）IDE初治患者，在现实生活中

StephenW

Int J Clin Pharm. 2015 Sep 12. [Epub ahead of print]
Efficacy and safety of tenofovir in nucleos(t)ide-naïve patients with genotype C chronic hepatitis B in real-life practice.Kim JH1, Jung SW1, Byun SS1, Shin JW1, Park BR2, Kim MH2, Kim CJ2, Park NH3,4.
Author information

• 1Department of Internal Medicine, University of Ulsan College of Medicine, Ulsan University Hospital, 290-3 Jeonha-dong, Dong-gu, Ulsan, 682-714, Republic of Korea.
• 2Biomedical Research Center, University of Ulsan College of Medicine, Ulsan University Hospital, Ulsan, Republic of Korea.
• 3Department of Internal Medicine, University of Ulsan College of Medicine, Ulsan University Hospital, 290-3 Jeonha-dong, Dong-gu, Ulsan, 682-714, Republic of Korea. [email protected].
• 4Biomedical Research Center, University of Ulsan College of Medicine, Ulsan University Hospital, Ulsan, Republic of Korea. [email protected].
  

AbstractBackground Tenofovir disoproxil fumarate (TDF) has demonstrated potent antiviral activity against hepatitis B virus (HBV) in clinical trials. Although its efficacy has been demonstrated in Caucasian populations, TDF has not previously been studied in Korean patients who present the predominance of HBV genotype C and of vertical or perinatal transmission. Objective The aim of this study was to evaluate the efficacy of TDF in Korean chronic hepatitis B (CHB) patients in real-life practice, and to determine the clinical variables that contribute to virologic response.Setting Large academic medical center in Korea. Method We retrospectively investigated the efficacy of TDF treatment for more than 6 months in 151 nucleos(t)ide-naïve CHB patients. Main outcome measure The primary endpoint was a virologic response (VR), defined as an HBV DNA level of <12 IU/mL. Secondary endpoints were rates of alanine aminotransaminase (ALT) normalization, hepatitis B e antigen (HBeAg) seroconversion, virologic breakthrough, and safety. Results All patients were the genotype C2. The median duration of TDF treatment was 13 months (range 7-18 months). Ninety-two (61.0 %) patients were HBeAg positive. The mean pre-treatment HBV DNA level was 6.34 ± 1.42 log10 IU/mL. Among the 131 patients with elevated ALT levels at baseline, 128 (97.7 %) patients achieved ALT normalization during TDF treatment. VR was achieved in 97 (64.2 %) patients. The cumulative rates of VR at 6, 9, 12, and 18 months were 47.0, 59.4, 67.9, and 69.3 %, respectively. Among the 92 HBeAg-positive patients, 14 (15.2 %) patients achieved HBeAg seroconversion. In multivariate analysis, absolute HBV DNA levels at baseline (P < 0.001; OR 0.529; 95 % CI 0.560-0.744) and HBeAg positivity (P = 0.015; OR 0.731; 95 % CI 0.615-0.869) were significantly associated with VR. Virologic breakthrough was observed in four patients. These four patients had poor adherence to TDF. Most of the adverse events were mild in severity. No significant changes were observed in serum creatinine and phosphorus levels. Conclusions TDF was effective and well tolerated in Korean genotype C CHB patients in real life practice, consistent with larger registration trials. The absolute HBV DNA levels at baseline and HBeAg positivity were significantly associated with VR.


KEYWORDS: Chronic hepatitis B; Korea; Nucleos(t)ide-naïve; Real-life practice; Tenofovir

StephenW

诠释J万方数据医药。 2015年九月12 EPUB提前打印]
功效和替诺福韦的核苷安全（T）IDE初治患者，在现实生活中实践C基因型慢性乙型肝炎。
金JH1，荣格SW1，卞SS1，申JW1，公园BR2，金MH2，金CJ2，公园NH3​​,4。
作者信息

    教研室内科，医学蔚山大学大学，蔚山大学医院，290-3 Jeonha洞，东区，蔚山，682-714，大韩民国。
    2Biomedical研究中心，中医药大学蔚山大学，蔚山大学医院，蔚山，韩国。
    3Department内科，医学蔚山大学大学，蔚山大学医院，290-3 Jeonha洞，东区，蔚山，682-714，大韩民国。 [email protected]。
    4Biomedical研究中心，中医药大学蔚山大学，蔚山大学医院，蔚山，韩国。 [email protected]。

抽象的

背景富马酸替诺福韦酯（TDF）已经证明在临床试验中抗乙型肝炎病毒（HBV）有效的抗病毒活性。尽管其疗效已被证明在高加索人群，TDF以前未曾研究韩国患者谁提出HBV基因型C和垂直或围产期传输的优势。本研究的目的的目的是评估的TDF在韩语慢性乙型肝炎（CHB）的患者在实际生活实践中的功效，并确定向病毒学response.Setting在韩国大的学术医疗中心的临床变量。方法我们回顾性调查TDF治疗的功效，适用于6个月以上的151核苷（酸）IDE初治慢性乙肝患者。主要观察指标主要终点是病毒学应答（VR），定义为<12 IU /毫升的HBV DNA水平。次要终点为丙氨酸aminotransaminase（ALT）正常化，乙肝e抗原（HBeAg）血清转换，病毒学突破，安全率。结果所有患者的基因型C2。 TDF治疗时间中位数为13个月（7-18个月）。九十二（61.0％）患者HBeAg阳性。平均治疗前HBV DNA水平为6.34±1.42日志10 IU / mL的。其中131例ALT水平升高在基线，128（97.7％）患者在TDF治疗取得了ALT复常。 VR是在97（64.2％）患者达到。的VR 6，9，12，和18个月的累积率分别为47.0，59.4，67.9，和69.3％之间。其中92例HBeAg阳性患者中，14（15.2％）患者达到HBeAg血清转换。多变量分析显示，在基线绝对HBV DNA水平（P <0.001; OR 0.529; 95％CI为0.560-0.744）和HBeAg阳性（P = 0.015; OR 0.731; 95％CI为0.615-0.869）的显著与虚拟现实相关。病毒学突破，观察4例。这四个患者依从性差到TDF。大部分的不良反应为轻微的严重程度。无显著变化，观察血清肌酸酐和磷水平。结论：TDF是有效且耐受性良好韩国C基因型慢性乙型肝炎患者在现实生活中实践，具有较大的注册临床试验是一致的。绝对HBV DNA水平在基线和HBeAg阳性与VR被显著相关联。
关键词：

慢性乙型肝炎;韩国;核苷（酸）IDE-天真;现实生活中的实践;替诺福韦