title: Treatment Efficacy and Safety of Tenofovir-Based Therapy in Chronic Hepatitis B: A Real Life Cohort Study in Korea.
abstract: OBJECTIVE
  We evaluated the efficacy and safety of Tenofovir disoproxil fumarate (TDF)-based therapy in naïve and treatment-experienced chronic hepatitis B (CHB) patients for 96 weeks in Korean real life practice.
  
  
  METHODS
  A total of 209 CHB patients with a prescription for TDF at the Seoul and Daejeon St. Mary's hospitals were enrolled from December 2012 to October 2014. We compared the virological responses and evaluated the renal safety of treatment-naive and treatment-experienced patients.
  
  
  RESULTS
  An overall complete virological response (CVR) was achieved in 80.4% and 84.6% of patients at weeks 48 and 96, respectively. In a subgroup analysis, CVR at week 96 was present in 88.4%, 75.0%, 75.5%, and 83.3% of participants in the lamivudine-resistant (LAM-R) group, adefovir-resistant (ADV-R) group, multidrug-resistant (MDR) group, and suboptimal response group, respectively. In a multivariate analysis, ADV-R, MDR, hepatitis B virus DNA, and hepatitis B e antigen were independent predictors for CVR. With regard to renal safety, diabetes mellitus, cirrhosis, and an initial low estimated glomerular filtration rate were independent factors affecting creatinine elevation (≥0.5 mg/dL). Moreover, two patients with DM and cirrhosis experienced TDF-related Fanconi syndrome.
  
  
  CONCLUSIONS
  TDF-based therapy demonstrated sustained viral suppression and favorable safety during a 2-year treatment period. The LAM-R and suboptimal response groups showed comparable efficacy to the naïve group, while the ADV-R and MDR groups were significantly associated with a low CVR. Close monitoring of renal safety should be mandatory when treating CHB patients receiving TDF, particularly those with DM and cirrhosis.
authors.affiliation: Department of Internal Medicine, Division of Hepatology and Gastroenterology, College of Medicine, The Catholic University of Korea, Seoul, Korea.
authors.forename: Hyo Jun
authors.initials: HJ
authors.lastname: Ahn
authors.affiliation: Department of Internal Medicine, Division of Hepatology and Gastroenterology, College of Medicine, The Catholic University of Korea, Seoul, Korea.
authors.forename: Myeong Jun
authors.initials: MJ
authors.lastname: Song
authors.affiliation: Department of Internal Medicine, Division of Hepatology and Gastroenterology, College of Medicine, The Catholic University of Korea, Seoul, Korea.
authors.forename: Jeong Won
authors.initials: JW
authors.lastname: Jang
authors.affiliation: Department of Internal Medicine, Division of Hepatology and Gastroenterology, College of Medicine, The Catholic University of Korea, Seoul, Korea.
authors.forename: Si Hyun
authors.initials: SH
authors.lastname: Bae
authors.affiliation: Department of Internal Medicine, Division of Hepatology and Gastroenterology, College of Medicine, The Catholic University of Korea, Seoul, Korea.
authors.forename: Jong Young
authors.initials: JY
authors.lastname: Choi
authors.affiliation: Department of Internal Medicine, Division of Hepatology and Gastroenterology, College of Medicine, The Catholic University of Korea, Seoul, Korea.
authors.forename: Seung Kew
authors.initials: SK
authors.lastname: Yoon
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D015331:Cohort Studies; D005260:Female; D019694:Hepatitis B, Chronic / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D056910:Republic of Korea; D000068698:Tenofovir / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000998:Antiviral Agents; D000068698:Tenofovir