%0 Journal Article
%T Assessment of HBV flare in a randomized clinical trial in HIV/HBV coinfected subjects initiating HBV-active antiretroviral therapy in Thailand
%A Anchalee Avihingsanon
%A Gail V Matthews
%A Sharon R Lewin
%A Pip Marks
%A Jose Sasadeusz
%A David A Cooper
%A Scott Bowden
%A Stephen Locarnini
%A Greg J Dore
%A Kiat Ruxrungtham
%J AIDS Research and Therapy
%D 2012
%I BioMed Central
%R 10.1186/1742-6405-9-6
%X The Tenofovir in HIV-HBV coinfection study was a randomized clinical trial of HBV-active HAART including lamivudine and/or tenofovir in antiretroviral na£¿ve HIV-HBV individuals in Thailand.Early HF (EHF) was defined as ALT > 5 ¡Á 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).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.NCT00192595.Hepatotoxicity (HT) after HAART initiation has been reported in 2-14% of HIV positive individuals [1-3], and the risk increases significantly in HBV or HCV coinfected individuals [1,4]. Definitions of HT vary but the most commonly used is based on the AIDS Clinical Trial Group (ACTG) criteria in which an increase in ALT and/or AST above 5 ¡Á upper limit of normal (ULN) (Grade 3) is defined as severe HT. HF (HF) appears to be particularly common within the first months after HAART initiation, suggesting a potential immunological component to its development. The outcome following HF may be beneficial with subsequent serological change; on the other it may also be associated with morbidity, and even mortality. Although, HF after initiation of HAART in HIV-HBV coinfected individuals is well recognized, prospective data on predictors and subsequent outcome are limited.We therefore examined the incidence
%K Hepatitis B
%K HIV
%K Antiretroviral therapy
%K Asia
%K Hepatic flare
%K Hepatotoxicity
%U http://www.aidsrestherapy.com/content/9/1/6