title: 96 weeks combination of adefovir dipivoxil plus emtricitabine vs. adefovir dipivoxil monotherapy in the treatment of chronic hepatitis B.
abstract: OBJECTIVE
  In order to prevent the occurrence of drug-resistant mutants associated with treatment for chronic hepatitis B virus (HBV) infection, combination therapy is being developed. To determine the efficacy of adefovir dipivoxil (ADV) plus emtricitabine (FTC) combination therapy in chronic HBV infection.
  
  
  METHODS
  Thirty treatment-nai ve, HBeAg-positive patients were randomized to combination ADV plus FTC (n=14) or ADV plus placebo monotherapy (n=16) for 96 weeks. HBV DNA was measured by polymerase chain reaction. Treatment was stopped in those with HBeAg seroconversion.
  
  
  RESULTS
  The median decrease in HBV DNA at week 96 was higher in the combination group (-5.30 vs. -3.98 log(10)copies/ml, p=0.05). More patients in the combination group had normalization of alanine aminotransaminase and HBV DNA<300 copies/ml at week 96 when compared with the monotherapy group [11 of the 14 patients (78.6%) vs. 6 of the 16 patients (37.5%), p=0.03]. However, HBeAg seroconversion at week 96 was similar in the 2 groups [2/14 (14.3%) vs. 4/16 (25.0%), p=NS]. No ADV or FTC resistance was detected at week 96. In those with HBeAg seroconversion, 50.0% had post-treatment relapse.
  
  
  CONCLUSIONS
  Combination ADV plus FTC resulted in more potent suppression of HBV DNA over 96 weeks of therapy.
authors.affiliation: Department of Microbiology, Queen Mary Hospital, The University of Hong Kong, Hong Kong SAR, China.
authors.forename: Chee-Kin
authors.initials: CK
authors.lastname: Hui
authors.forename: Hai-Ying
authors.initials: HY
authors.lastname: Zhang
authors.forename: Scott
authors.initials: S
authors.lastname: Bowden
authors.forename: Stephen
authors.initials: S
authors.lastname: Locarnini
authors.forename: John M
authors.initials: JM
authors.lastname: Luk
authors.forename: Kar-Wai
authors.initials: KW
authors.lastname: Leung
authors.forename: Yui-Hung
authors.initials: YH
authors.lastname: Yueng
authors.forename: April
authors.initials: A
authors.lastname: Wong
authors.forename: Frank
authors.initials: F
authors.lastname: Rousseau
authors.forename: Kwok-Yung
authors.initials: KY
authors.lastname: Yuen
authors.forename: Nikolai N
authors.initials: NN
authors.lastname: Naoumov
authors.forename: George K K
authors.initials: GK
authors.lastname: Lau
mesh_terms: D000225:Adenine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000627:therapeutic use*; D004279:DNA, Viral / Q000097:blood; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D024882:Drug Resistance, Viral; D004359:Drug Therapy, Combination; D000068679:Emtricitabine; D005260:Female; D006513:Hepatitis B e Antigens / Q000097:blood; D019694:Hepatitis B, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D008297:Male; D008875:Middle Aged; D063065:Organophosphonates / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D006513:Hepatitis B e Antigens; D063065:Organophosphonates; D003841:Deoxycytidine; D000410:Alanine Transaminase; D000068679:Emtricitabine; D000225:Adenine; C106812:adefovir dipivoxil