title: Tenofovir disoproxil fumarate monotherapy for nucleos(t)ide analogue-naïve and nucleos(t)ide analogue-experienced chronic hepatitis B patients.
abstract: OBJECTIVE
  This study investigated the antiviral effects of tenofovir disoproxil fumarate (TDF) monotherapy in nucleos(t)ide analogue (NA)-naive and NA-experienced chronic hepatitis B (CHB) patients.
  
  
  METHODS
  CHB patients treated with TDF monotherapy (300 mg/day) for ≥12 weeks between December 2012 and July 2014 at a single center were retrospectively enrolled. Clinical, biochemical, and virological parameters were assessed every 12 weeks.
  
  
  RESULTS
  In total, 136 patients (median age 49 years, 96 males, 94 HBeAg positive, and 51 with liver cirrhosis) were included. Sixty-two patients were nucleos(t)ide (NA)-naïve, and 74 patients had prior NA therapy (NA-exp group), and 31 patients in the NA-exp group had lamivudine (LAM)-resistance (LAM-R group). The baseline serum hepatitis B virus (HBV) DNA level was 4.9±2.3 log IU/mL (mean±SD), and was higher in the NA-naïve group than in the NA-exp and LAM-R groups (5.9±2.0 log IU/mL vs 3.9±2.0 log IU/mL vs 4.2±1.7 log IU/mL, P<0.01). The complete virological response (CVR) rate at week 48 in the NA-naïve group (71.4%) did not differ significantly from those in the NA-exp (71.3%) and LAM-R (66.1%) groups. In multivariate analysis, baseline serum HBV DNA was the only predictive factor for a CVR at week 48 (hazard ratio, 0.809; 95% confidence interval, 0.729-0.898), while the CVR rate did not differ with the NA experience.
  
  
  CONCLUSIONS
  TDF monotherapy was effective for CHB treatment irrespective of prior NA treatment or LAM resistance. Baseline serum HBV DNA was the independent predictive factor for a CVR.
authors.affiliation: Department of Internal Medicine, Ilsan Paik Hospital, Inje University College of Medicine, Goyang, Korea.
authors.forename: Sang Kyung
authors.initials: SK
authors.lastname: Jung
authors.affiliation: Department of Internal Medicine, Ilsan Paik Hospital, Inje University College of Medicine, Goyang, Korea.
authors.forename: Kyung-Ah
authors.initials: KA
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, Ilsan Paik Hospital, Inje University College of Medicine, Goyang, Korea.
authors.forename: So Young
authors.initials: SY
authors.lastname: Ha
authors.affiliation: Department of Internal Medicine, Ilsan Paik Hospital, Inje University College of Medicine, Goyang, Korea.
authors.forename: Hyun Kyo
authors.initials: HK
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, Ilsan Paik Hospital, Inje University College of Medicine, Goyang, Korea.
authors.forename: Young Doo
authors.initials: YD
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, Ilsan Paik Hospital, Inje University College of Medicine, Goyang, Korea.
authors.forename: Bu Hyun
authors.initials: BH
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, Ilsan Paik Hospital, Inje University College of Medicine, Goyang, Korea.
authors.forename: Woo Hyun
authors.initials: WH
authors.lastname: Paik
authors.affiliation: Department of Internal Medicine, Ilsan Paik Hospital, Inje University College of Medicine, Goyang, Korea.
authors.forename: Jong Wook
authors.initials: JW
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, Ilsan Paik Hospital, Inje University College of Medicine, Goyang, Korea.
authors.forename: Won Ki
authors.initials: WK
authors.lastname: Bae
authors.affiliation: Department of Internal Medicine, Ilsan Paik Hospital, Inje University College of Medicine, Goyang, Korea.
authors.forename: Nam-Hoon
authors.initials: NH
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, Ilsan Paik Hospital, Inje University College of Medicine, Goyang, Korea.
authors.forename: June Sung
authors.initials: JS
authors.lastname: Lee
authors.affiliation: Health promotion center Ilsan Paik Hospital, Inje University College of Medicine, Goyang, Korea.
authors.forename: Yoon Jung
authors.initials: YJ
authors.lastname: Jwa
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000998:Antiviral Agents / Q000627:therapeutic use*; D004279:DNA, Viral / Q000097:blood; D024882:Drug Resistance, Viral; D005260:Female; D006513:Hepatitis B e Antigens / Q000097:blood; D006515:Hepatitis B virus / Q000235:genetics; D019694:Hepatitis B, Chronic / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D019259:Lamivudine / Q000627:therapeutic use; D008103:Liver Cirrhosis / Q000209:etiology; D008297:Male; D008875:Middle Aged; D009711:Nucleotides / Q000737:chemistry* / Q000627:therapeutic use; D012189:Retrospective Studies; D000068698:Tenofovir / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D006513:Hepatitis B e Antigens; D009711:Nucleotides; D019259:Lamivudine; D000068698:Tenofovir
keywords: Chronic Hepatitis B; Lamivudine-resistant; Nucleos(t)ide analogue-experienced; Tenofovir
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