Efficacy and Safety of Tenofovir Disoproxil Fumarate in Treatment-Naïve Patients with Chronic Hepatitis B in Korea

Digestive Diseases and Sciences - 2019
Jung Hyun Kwon1, Myeong Jun Song2, Jeong Won Jang3, Si Hyun Bae3, Jong Young Choi3, Seung Kew Yoon3, Hee Yeon Kim4, Chang Wook Kim4, Do Seon Song5, U. Im Chang5, Jin Mo Yang5, Chan Ran You6, Sang Wook Choi6, Hae Lim Lee7, Sung Won Lee7, Nam Ik Han7, Soon Woo Nam1, Sang Gyune Kim8, Young Seok Kim8, Seok Hyun Kim9, Byung Seok Lee9, Tae Hee Lee10, Eun-Young Cho11
1Division of Hepatology, Department of Internal Medicine, Incheon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea
2Division of Hepatology, Department of Internal Medicine, Daejeon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea
3Division of Hepatology, Department of Internal Medicine, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea
4Division of Hepatology, Department of Internal Medicine, Uijeongbu St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea
5Division of Hepatology, Department of Internal Medicine, St. Vincent’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea
6Division of Hepatology, Department of Internal Medicine, St. Paul’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea
7Division of Hepatology, Department of Internal Medicine, Bucheon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea
8Digestive Disease Center, Department of Internal Medicine, Soonchunghyang University College of Medicine, Bucheon, South Korea
9Department of Internal Medicine, Chungnam University College of Medicine, Daejeon, South Korea
10Department of Internal Medicine, Konyang University College of Medicine, Daejeon, South Korea
11Department of Internal Medicine, Wonkwang University School of Medicine, Iksan, South Korea

Tóm tắt

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

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Digestive Diseases and Sciences

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