替诺福韦地索普西富马酸盐治疗初治韩国慢性乙型肝炎患者

StephenW

Digestive Diseases and Sciences

July 2019, Volume 64, Issue 7, pp 2039–2048 | Cite as
Efficacy and Safety of Tenofovir Disoproxil Fumarate in Treatment-Naïve Patients with Chronic Hepatitis B in Korea

    Authors
    Authors and affiliations

    Jung Hyun KwonMyeong Jun SongEmail authorJeong Won JangSi Hyun BaeJong Young ChoiSeung Kew YoonHee Yeon KimChang Wook KimDo Seon SongU. Im ChangJin Mo YangChan Ran YouSang Wook ChoiHae Lim LeeSung Won Lee

    Jung Hyun Kwon
        1
    Myeong Jun Song
        2Email authorView author's OrcID profile
    Jeong Won Jang
        3
    Si Hyun Bae
        3
    Jong Young Choi
        3
    Seung Kew Yoon
        3
    Hee Yeon Kim
        4
    Chang Wook Kim
        4
    Do Seon Song
        5
    U. Im Chang
        5
    Jin Mo Yang
        5
    Chan Ran You
        6
    Sang Wook Choi
        6
    Hae Lim Lee
        7
    Sung Won Lee
        7
    Nam Ik Han
        7
    Soon Woo Nam
        1
    Sang Gyune Kim
        8
    Young Seok Kim
        8
    Seok Hyun Kim
        9
    Byung Seok Lee
        9
    Tae Hee Lee
        10
    Eun-Young Cho
        11

    1.Division of Hepatology, Department of Internal Medicine, Incheon St. Mary’s Hospital, College of MedicineThe Catholic University of KoreaSeoulSouth Korea
    2.Division of Hepatology, Department of Internal Medicine, Daejeon St. Mary’s Hospital, College of MedicineThe Catholic University of KoreaSeoulSouth Korea
    3.Division of Hepatology, Department of Internal Medicine, Seoul St. Mary’s Hospital, College of MedicineThe Catholic University of KoreaSeoulSouth Korea
    4.Division of Hepatology, Department of Internal Medicine, Uijeongbu St. Mary’s Hospital, College of MedicineThe Catholic University of KoreaSeoulSouth Korea
    5.Division of Hepatology, Department of Internal Medicine, St. Vincent’s Hospital, College of MedicineThe Catholic University of KoreaSeoulSouth Korea
    6.Division of Hepatology, Department of Internal Medicine, St. Paul’s Hospital, College of MedicineThe Catholic University of KoreaSeoulSouth Korea
    7.Division of Hepatology, Department of Internal Medicine, Bucheon St. Mary’s Hospital, College of MedicineThe Catholic University of KoreaSeoulSouth Korea
    8.Digestive Disease Center, Department of Internal MedicineSoonchunghyang University College of MedicineBucheonSouth Korea
    9.Department of Internal MedicineChungnam University College of MedicineDaejeonSouth Korea
    10.Department of Internal MedicineKonyang University College of MedicineDaejeonSouth Korea
    11.Department of Internal MedicineWonkwang University School of MedicineIksanSouth Korea

Original Article
First Online: 06 February 2019

    128 Downloads

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
Tenofovir disoproxil fumarate Chronic hepatitis B Virologic response Safety

StephenW

消化系统疾病与科学

2019年7月，第64卷，第7期，第2039-2048页引用为
替诺福韦地索普西富马酸盐治疗初治韩国慢性乙型肝炎患者的疗效和安全性

    作者
    作者和附属机构

    Jung Hyun KwonMyeong Jun Song电子邮件作者Jongong JangSi Hyun BaeJong Young ChoiSeung Kew YoonHee Yeon KimChang Wook KimDo Seon SongU。 Im ChangJin Mo YangChan Ran YouSang Wook ChoiHae Lim Lee Suung Lee Lee

    Jung Hyun Kwon
        1
    明君宋
        2Email authorView作者的OrcID个人资料
    Jeong Won Jang
        3
    Si Hyun Bae
        3
    Jong Young Choi
        3
    Seung Kew Yoon
        3
    Hee Yeon Kim
        4
    Chang Wook Kim
        4
    做Seon Song
        五
    U. Im Chang
        五
    金莫阳
        五
    陈然游
        6
    Sang Wook Choi
        6
    Hae Lim Lee
        7
    Sung Won Lee
        7
    Nam Ik Han
        7
    很快Woo Nam
        1
    Sang Gyune Kim
        8
    Young Seok Kim
        8
    Seok Hyun Kim
        9
    Byung Seok Lee
        9
    Tae Hee Lee
        10
    Eun-Young Cho
        11

    1.韩国天主教大学仁川圣玛丽医院内科，肝病科，首尔南韩
    2.医学院大田圣玛丽医院内科，肝病科，韩国天主教大学，首尔，韩国
    3.韩国天主教大学首尔圣玛丽医院内科，肝病科，首尔南韩
    4.医学院内部医学院内部医学科，韩国天主教大学首尔南韩
    5.医学院圣文森医院内科，肝病科，韩国天主教大学，首尔，韩国
    6.医学院圣保罗医院内科，肝病科，韩国天主教大学，首尔，韩国
    7.医学院，富川市圣玛丽医院内科，肝病科，韩国天主教大学，首尔，韩国
    8.消化疾病中心，内科，顺天乡大学医学院，富川韩国
    9.Chungnam大学医学院内科大学韩国
    10.Konyang大学医学院内科DaejeonSouth Korea
    11.内科医学院钦光大学医学院益山南韩

来源文章
首次在线：2019年2月6日

    128次下载

抽象
目标

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
替诺福韦地索普西富马酸盐慢性乙型肝炎病毒学应答安全性
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