Vol.:(0123456789) 1 3 Digestive Diseases and Sciences https://doi.org/10.1007/s10620-019-05489-7 ORIGINAL ARTICLE Efcacy and Safety of Tenofovir Disoproxil Fumarate in Treatment‑Naïve Patients with Chronic Hepatitis B in Korea Jung Hyun Kwon 1  · Myeong Jun Song 2  · 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 Received: 15 October 2018 / Accepted: 22 January 2019 © Springer Science+Business Media, LLC, part of Springer Nature 2019 Abstract Aims To evaluate the efcacy 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 signifcantly 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 profle over a 3-year period. How- ever, 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 * Myeong Jun Song mjsong95@gmail.com 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 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