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

• Published in: Digestive diseases and sciences Vol. 64; no. 7; pp. 2039 - 2048
• Main Authors: Kwon, Jung Hyun, Song, Myeong Jun, Jang, Jeong Won, Bae, Si Hyun, Choi, Jong Young, Yoon, Seung Kew, Kim, Hee Yeon, Kim, Chang Wook, Song, Do Seon, Chang, U. Im, Yang, Jin Mo, You, Chan Ran, Choi, Sang Wook, Lee, Hae Lim, Lee, Sung Won, Han, Nam Ik, Nam, Soon Woo, Kim, Sang Gyune, Kim, Young Seok, Kim, Seok Hyun, Lee, Byung Seok, Lee, Tae Hee, Cho, Eun-Young
• Format: Journal Article
• Language: English
• Published: New York Springer US 15.07.2019; Springer; Springer Nature B.V
• Subjects: Adefovir dipivoxil; Adult; Antiretroviral drugs; Antiviral Agents - adverse effects; Antiviral Agents - therapeutic use; Biochemistry; Care and treatment; Clinical medicine; Creatinine; Deoxyribonucleic acid; Development and progression; Disease; DNA; Female; Gastroenterology; Hepatitis; Hepatitis B; Hepatitis B, Chronic - diagnosis; Hepatitis B, Chronic - drug therapy; Hepatology; Hospitals; Humans; Infections; Interferon; Internal medicine; Kidney - drug effects; Kidney - physiopathology; Kidney Diseases - chemically induced; Kidney Diseases - physiopathology; Kidneys; Liver cancer; Liver cirrhosis; Male; Medical centers; Medical schools; Medicine; Medicine & Public Health; Middle Aged; Mortality; Oncology; Original Article; Patient Safety; Prospective Studies; Republic of Korea; Retrospective Studies; Risk Assessment; Risk Factors; Sustained Virologic Response; Telbivudine; Tenofovir; Tenofovir - adverse effects; Tenofovir - therapeutic use; Time Factors; Transplant Surgery; Treatment Outcome; University colleges; Viral Load; Republic of Korea; Virologic response; Safety; Chronic hepatitis B; Tenofovir disoproxil fumarate
• ISSN: 0163-2116; 1573-2568
• DOI: 10.1007/s10620-019-05489-7

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.