替诺福韦地索普西富马酸盐在治疗初治韩国慢性乙型肝炎患

StephenW

Dig Dis Sci. 2019 Feb 6. doi: 10.1007/s10620-019-05489-7. [Epub ahead of print]
Efficacy and Safety of Tenofovir Disoproxil Fumarate in Treatment-Naïve Patients with Chronic Hepatitis B in Korea.
Kwon JH1, Song MJ2, Jang JW3, Bae SH3, Choi JY3, Yoon SK3, Kim HY4, Kim CW4, Song DS5, Chang UI5, Yang JM5, You CR6, Choi SW6, Lee HL7, Lee SW7, Han NI7, Nam SW1, Kim SG8, Kim YS8, Kim SH9, Lee BS9, Lee TH10, Cho EY11.
Author information

1
    Division of Hepatology, Department of Internal Medicine, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.
2
    Division of Hepatology, Department of Internal Medicine, Daejeon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea. [email protected].
3
    Division of Hepatology, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.
4
    Division of Hepatology, Department of Internal Medicine, Uijeongbu St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.
5
    Division of Hepatology, Department of Internal Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.
6
    Division of Hepatology, Department of Internal Medicine, St. Paul's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.
7
    Division of Hepatology, Department of Internal Medicine, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.
8
    Digestive Disease Center, Department of Internal Medicine, Soonchunghyang University College of Medicine, Bucheon, South Korea.
9
    Department of Internal Medicine, Chungnam University College of Medicine, Daejeon, South Korea.
10
    Department of Internal Medicine, Konyang University College of Medicine, Daejeon, South Korea.
11
    Department of Internal Medicine, Wonkwang University School of Medicine, Iksan, South Korea.

Abstract
AIMS:

To evaluate the efficacy and safety of 144-week tenofovir disoproxil fumarate (TDF) therapy in treatment-naïve chronic hepatitis B (CHB) patients in Korean.
METHODS:

In total, 579 treatment-naïve CHB patients at 11 medical centers were enrolled retrospective and prospective from September 2015 to January 2016 by design (NCT02533544). We evaluated the complete virologic response (CVR) rate and the renal safety of TDF.
RESULTS:

The overall CVR rate was 69.4%, 87.0%, and 89.7% at weeks 48, 96, and 144, respectively. In the HBeAg-positive CHB patients, the CVR rate at weeks 48, 96, and 144 was 61.4%, 83.1%, and 89.6%, respectively. The rates of HBeAg loss and seroconversion at weeks 48, 96, and 144 were 16.6%, 23.5%, 34.1%, and 7.6%, 8.9%, 13.3%, respectively. In HBeAg-negative CHB patients, the CVR rate at weeks 48, 96, and 144 was 82.5%, 93.2%, and 90.0%, respectively. The rate of alanine aminotransferase normalization was 36.9%, 45.4%, and 46.8% at weeks 48, 96, and 144, respectively. Of the CHB patients, 0.9% showed an elevated creatinine (> 0.5 mg/dL from baseline). Age (≥ 60 years) was significantly associated with a decline in renal function at week 144 (P < 0.0001). Comorbidities (diabetes or hypertension) showed the tendency to reduce renal function (P = 0.0624). Hepatocellular carcinoma developed in 10 (1.7%) patients and was related to cirrhosis.
CONCLUSIONS:

TDF therapy induced sustained viral suppression and had a favorable safety profile over a 3-year period. However, close monitoring of renal function should be mandatory in treating CHB patients receiving TDF, particularly older patients.
KEYWORDS:

Chronic hepatitis B; Safety; Tenofovir disoproxil fumarate; Virologic response

PMID:
    30725293
DOI:
    10.1007/s10620-019-05489-7

StephenW

Dig Dis Sci。 2019年2月6日doi：10.1007 / s10620-019-05489-7。 [印刷前的电子版]
替诺福韦地索普西富马酸盐在治疗初治韩国慢性乙型肝炎患者中的疗效和安全性。
Kwon JH1，Song MJ2，Jang JW3，Bae SH3，Choi JY3，Yoon SK3，Kim HY4，Kim CW4，Song DS5，Chang UI5，Yang JM5，You CR6，Choi SW6，Lee HL7，Lee SW7，Han NI7，Nam SW1 ，Kim SG8，Kim YS8，Kim SH9，Lee BS9，Lee TH10，Cho EY11。
作者信息

1
    韩国天主教大学医学院仁川圣玛丽医院内科，肝病科，韩国首尔。
2
    韩国天主教大学医学院大田圣玛丽医院内科，肝病科，韩国首尔。 [email protected]。
3
    韩国天主教大学医学院首尔圣玛丽医院内科，肝内科，韩国首尔。
4
    韩国天主教大学医学院Uijeongbu St. Mary医院内科，肝病科，韩国首尔。
五
    韩国天主教大学医学院圣文森特医院内科，肝病科，韩国首尔。
6
    韩国天主教大学医学院圣保罗医院内科，肝病科，韩国首尔。
7
    韩国天主教大学医学院，富川圣玛丽医院内科，肝病科，韩国首尔。
8
    韩国富川顺天大学医学院内科消化疾病中心。
9
    韩国大田忠南大学医学院内科
10
    韩国大田Konyang大学医学院内科
11
    韩国益山市万王大学医学院内科。

抽象
目的：

评估144周替诺福韦地索普西富马酸盐（TDF）治疗韩国治疗初治慢性乙型肝炎（CHB）患者的疗效和安全性。
方法：

总共有来自11个医疗中心的579名未接受治疗的CHB患者在2015年9月至2016年1月的设计（NCT02533544）进行了回顾性和前瞻性研究。我们评估了完整的病毒学应答（CVR）率和TDF的肾脏安全性。
结果：

第48周，第96周和第144周的总CVR率分别为69.4％，87.0％和89.7％。在HBeAg阳性的CHB患者中，第48,96和144周的CVR率分别为61.4％，83.1％和89.6％。第48,96和144周的HBeAg消失和血清转换率分别为16.6％，23.5％，34.1％和7.6％，8.9％，13.3％。在HBeAg阴性的CHB患者中，第48,96和144周的CVR率分别为82.5％，93.2％和90.0％。在第48,96和144周，丙氨酸氨基转移酶标准化率分别为36.9％，45.4％和46.8％。在CHB患者中，0.9％显示肌酐升高（从基线开始> 0.5mg / dL）。年龄（≥60岁）与144周时肾功能下降显着相关（P <0.0001）。合并症（糖尿病或高血压）显示出降低肾功能的倾向（P = 0.0624）。肝细胞癌在10例（1.7％）患者中发展，并与肝硬化有关。
结论：

TDF疗法诱导持续的病毒抑制并且在3年期间具有良好的安全性。然而，在接受TDF治疗的CHB患者，特别是老年患者中，必须密切监测肾功能。
关键词：

慢性乙型肝炎;安全;替诺福韦地索普西富马酸盐;病毒学反应

结论：
    30725293
DOI：
    10.1007 / s10620-019-05489-7