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
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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 作者: StephenW 时间: 2019-6-24 20:05
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