title: [Efficacy of tenofovir-based rescue therapy for patients with drug-resistant chronic hepatitis B].
abstract: OBJECTIVE
  Tenofovir disoproxil fumarate (TDF) plays a pivotal role in the management of drug-resistant chronic hepatitis B. However, it remains unclear whether TDF-nucleoside analogue combination therapy provides better outcomes than TDF monotherapy. This study aimed to compare the efficacy of TDF monotherapy with that of TDF-nucleoside analogue combination therapy in patients with drug-resistant chronic hepatitis B.
  
  
  METHODS
  This retrospective cohort study included 76 patients receiving TDF-based rescue therapy for more than 12 months. Suboptimal response was defined as serum HBV-DNA level of > 60 IU/mL during prior rescue therapy. Multi-drug resistance was defined as the presence of two or more drug resistance-related mutations confirmed by mutation detection assay. The relationship between baseline characteristics and virologic response (HBV DNA < 20 IU/mL) at 12 months were evaluated using logistic regression analysis.
  
  
  RESULTS
  Fifty-five patients (72.4%) were suboptimal responders to prior rescue therapy, and 26 (34.2%) had multi-drug resistance. Forty-two patients (55.3%) received combination therapy with nucleoside analogues. Virologic response at 12 months was not significantly different between the TDF monotherapy group and TDF-nucleoside analogue combination therapy group (p = 0.098). The serum HBV DNA level was reduced to -4.49 ± 1.67 log10 IU/mL in the TDF monotherapy group and to -3.97 ± 1.69 log10 IU/mL in the TDF-nucleoside analogue combination therapy group at 12 months (p = 0.18). In multivariate analysis, female sex (p = 0.032), low baseline HBV-DNA level (p = 0.013), and TDF monotherapy (p = 0.046) were predictive factors for virologic response at 12 months.
  
  
  CONCLUSIONS
  TDF monotherapy showed similar efficacy to that of TDF-nucleoside analogue combination therapy in patients with drug-resistant chronic hepatitis B.
authors.affiliation: Departments of Internal Medicine, Soonchunhyang University Cheonan Hospital, Cheonan, Korea.
authors.forename: Kanghyug
authors.initials: K
authors.lastname: Choi
authors.affiliation: Departments of Internal Medicine, Soonchunhyang University Cheonan Hospital, Cheonan, Korea.
authors.forename: Han Min
authors.initials: HM
authors.lastname: Lee
authors.affiliation: Departments of Internal Medicine, Soonchunhyang University Cheonan Hospital, Cheonan, Korea.
authors.forename: Baek Gyu
authors.initials: BG
authors.lastname: Jun
authors.affiliation: Departments of Internal Medicine, Soonchunhyang University Cheonan Hospital, Cheonan, Korea.
authors.forename: Sae Hwan
authors.initials: SH
authors.lastname: Lee
authors.affiliation: Departments of Internal Medicine, Soonchunhyang University Cheonan Hospital, Cheonan, Korea.
authors.forename: Hong Soo
authors.initials: HS
authors.lastname: Kim
authors.affiliation: Departments of Internal Medicine, Soonchunhyang University Bucheon Hospital, Bucheon, Korea.
authors.forename: Sang Gyune
authors.initials: SG
authors.lastname: Kim
authors.affiliation: Departments of Internal Medicine, Soonchunhyang University Bucheon Hospital, Bucheon, Korea.
authors.forename: Young Seok
authors.initials: YS
authors.lastname: Kim
authors.affiliation: Departments of Internal Medicine, Soonchunhyang University Bucheon Hospital, Bucheon, Korea.
authors.forename: Boo Sung
authors.initials: BS
authors.lastname: Kim
authors.affiliation: Departments of Internal Medicine, Seoul Hospital, Seoul, Korea.
authors.forename: Soung Won
authors.initials: SW
authors.lastname: Jeong
authors.affiliation: Departments of Internal Medicine, Seoul Hospital, Seoul, Korea.
authors.forename: Jae Young
authors.initials: JY
authors.lastname: Jang
authors.affiliation: Department of Internal Medicine, University of Ulsan College of Medicine, Gangneung Asan Hospital, Gangneung, Korea.
authors.forename: Young Don
authors.initials: YD
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, University of Ulsan College of Medicine, Gangneung Asan Hospital, Gangneung, Korea.
authors.forename: Gab Jin
authors.initials: GJ
authors.lastname: Cheon
mesh_terms: D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000494:pharmacology / Q000627:therapeutic use*; D015331:Cohort Studies; D004279:DNA, Viral / Q000097:blood; D024882:Drug Resistance, Viral; D004359:Drug Therapy, Combination; D005260:Female; D006515:Hepatitis B virus / Q000187:drug effects / Q000235:genetics / Q000302:isolation & purification; D019694:Hepatitis B, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009705:Nucleosides / Q000737:chemistry / Q000627:therapeutic use; D012189:Retrospective Studies; D012737:Sex Factors; D000068698:Tenofovir / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D009705:Nucleosides; D000068698:Tenofovir