Background: Hepatic Flare (HF) after initiation of highly active antiretroviral therapy (HAART) in HIV-HBV coinfected\r\nindividuals is well recognized but prospective data on predictors and subsequent outcome are limited.\r\nMethods: The Tenofovir in HIV-HBV coinfection study was a randomized clinical trial of HBV-active HAART\r\nincluding lamivudine and/or tenofovir in antiretroviral naÃ?¯ve HIV-HBV individuals in Thailand.\r\nResults: Early HF (EHF) was defined as ALT > 5 Ã?â?? ULN during the first 12 weeks. EHF was observed in 8 (22%) of\r\nindividuals at a median of 56 days. 6/8 EHF cases were asymptomatic and resolved with HAART continuation,\r\nhowever one subject with underlying cirrhosis died following rapid hepatic decompensation. EHF was significantly\r\nassociated 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\r\nlog10 c/ml non EHF, p = 0.009), and subsequent serological change. HBeAg loss occurred in 75% of EHF cases\r\nversus 22% in non-EHF (p = 0.04), and HBsAg loss in 25% of EHF cases versus 4% of non-EHF (p = 0.053).\r\nConclusion: EHF after HBV active HAART initiation was frequently observed in this population. Timing of EHF,\r\nassociation with elevated ALT and HBV DNA and high rate of seroconversion are all consistent with immune\r\nrestoration as the likely underlying process.\r\nClinical Trial number: NCT00192595
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