Assessment of HBV flare in a randomized clinical trial in HIV/HBV coinfected subjects initiating HBV-active antiretroviral therapy in Thailand

AIDS Research and Therapy

Kiat Ruxrungtham³  Greg J Dore⁴  Stephen Locarnini²  Scott Bowden²  David A Cooper⁴  Jose Sasadeusz⁶  Pip Marks⁴  Sharon R Lewin¹  Gail V Matthews⁵  Anchalee Avihingsanon³ 

[1]Centre for Virology, Burnet Institute, Melbourne, Australia

[2]Victorian Infectious Diseases Reference Laboratory, Melbourne, Australia

[3]Division of Allergy and Clinical Immunology, Faculty of Medicine, Bangkok, Thailand

[4]The Kirby Institute for infection and immunity in society, University of New South Wales, Sydney, Australia

[5]The Kirby Institute for infection and immunity in society, University of NSW, 376 Victoria Street, Darlinghurst, Sydney, NSW 2010, Australia

[6]Victorian Infectious Diseases Service, Royal Melbourne Hospital, Melbourne, Australia

关键词: Hepatotoxicity;    Hepatic flare;    Asia;    Antiretroviral therapy;    HIV;    Hepatitis B;   

Others  :  789676
DOI  :  10.1186/1742-6405-9-6

 received in 2011-12-28, accepted in 2012-03-09,  发布年份 2012

【 摘 要 】

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).

Conclusion

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.

【 授权许可】

   
2012 Avihingsanon et al; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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