title: Assessment of HBV flare in a randomized clinical trial in HIV/HBV coinfected subjects initiating HBV-active antiretroviral therapy in Thailand.
abstract: BACKGROUND
  Hepatic Flare (HF) after initiation of highly active antiretroviral therapy (HAART) in HIV-HBV coinfected individuals is well recognized but prospective data on predictors and subsequent outcome are limited.
  
  
  METHODS
  The Tenofovir in HIV-HBV coinfection study was a randomized clinical trial of HBV-active HAART including lamivudine and/or tenofovir in antiretroviral naïve HIV-HBV individuals in Thailand.
  
  
  RESULTS
  Early HF (EHF) was defined as ALT > 5 × ULN during the first 12 weeks. EHF was observed in 8 (22%) of individuals at a median of 56 days. 6/8 EHF cases were asymptomatic and resolved with HAART continuation, however one subject with underlying cirrhosis died following rapid hepatic decompensation. EHF was significantly associated with higher baseline ALT (79 IU/L vs 36 IU/L non-EHF, p = 0.008) and HBV DNA (9.9 log10 c/ml vs 8.4 log10 c/ml non EHF, p = 0.009), and subsequent serological change. HBeAg loss occurred in 75% of EHF cases versus 22% in non-EHF (p = 0.04), and HBsAg loss in 25% of EHF cases versus 4% of non-EHF (p = 0.053).
  
  
  CONCLUSIONS
  EHF after HBV active HAART initiation was frequently observed in this population. Timing of EHF, association with elevated ALT and HBV DNA and high rate of seroconversion are all consistent with immune restoration as the likely underlying process.
  
  
  BACKGROUND
  NCT00192595.
authors.affiliation: HIV-NAT Thai Red Cross AIDS Research Centre, Bangkok, Thailand.|Division of Allergy and Clinical Immunology, Faculty of Medicine, Bangkok, Thailand.
authors.forename: Anchalee
authors.initials: A
authors.lastname: Avihingsanon
authors.affiliation: The Kirby Institute for infection and immunity in society, University of New South Wales, Sydney, Australia.|The Kirby Institute for infection and immunity in society, University of NSW, 376 Victoria Street, Darlinghurst, Sydney, NSW 2010, Australia.
authors.forename: Gail V
authors.initials: GV
authors.lastname: Matthews
authors.affiliation: Infectious Diseases Unit, The Alfred Hospital, Melbourne, Australia.|Department of Medicine, Monash University, Melbourne, Australia.|Centre for Virology, Burnet Institute, Melbourne, Australia.
authors.forename: Sharon R
authors.initials: SR
authors.lastname: Lewin
authors.affiliation: The Kirby Institute for infection and immunity in society, University of New South Wales, Sydney, Australia.
authors.forename: Pip
authors.initials: P
authors.lastname: Marks
authors.affiliation: Infectious Diseases Unit, The Alfred Hospital, Melbourne, Australia.|Victorian Infectious Diseases Service, Royal Melbourne Hospital, Melbourne, Australia.
authors.forename: Jose
authors.initials: J
authors.lastname: Sasadeusz
authors.affiliation: The Kirby Institute for infection and immunity in society, University of New South Wales, Sydney, Australia.
authors.forename: David A
authors.initials: DA
authors.lastname: Cooper
authors.affiliation: Victorian Infectious Diseases Reference Laboratory, Melbourne, Australia.
authors.forename: Scott
authors.initials: S
authors.lastname: Bowden
authors.affiliation: Victorian Infectious Diseases Reference Laboratory, Melbourne, Australia.
authors.forename: Stephen
authors.initials: S
authors.lastname: Locarnini
authors.affiliation: The Kirby Institute for infection and immunity in society, University of New South Wales, Sydney, Australia.
authors.forename: Greg J
authors.initials: GJ
authors.lastname: Dore
authors.affiliation: HIV-NAT Thai Red Cross AIDS Research Centre, Bangkok, Thailand.|Division of Allergy and Clinical Immunology, Faculty of Medicine, Bangkok, Thailand.
authors.forename: Kiat
authors.initials: K
authors.lastname: Ruxrungtham