Viral Hepatitis

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A randomized trial of combination hepatitis B therapy in HIV/HBV coinfected antiretroviral naïve individuals in Thailand†

  1. Gail V. Matthews1,‡,§,*,
  2. Anchalee Avihingsanon2,‡,
  3. Sharon R. Lewin3,4,
  4. Janaki Amin1,
  5. Rungsun Rerknimitr5,
  6. Panusit Petcharapirat5,
  7. Pip Marks1,
  8. Joe Sasadeusz6,
  9. David A. Cooper1,
  10. Scott Bowden7,
  11. Stephen Locarnini7,
  12. Kiat Ruxrungtham2,8,
  13. Gregory J. Dore1

Article first published online: 11 AUG 2008

DOI: 10.1002/hep.22462

Issue

Hepatology

Hepatology

Volume 48, Issue 4, pages 1062–1069, October 2008

Additional Information

How to Cite

Matthews, G. V., Avihingsanon, A., Lewin, S. R., Amin, J., Rerknimitr, R., Petcharapirat, P., Marks, P., Sasadeusz, J., Cooper, D. A., Bowden, S., Locarnini, S., Ruxrungtham, K. and Dore, G. J. (2008), A randomized trial of combination hepatitis B therapy in HIV/HBV coinfected antiretroviral naïve individuals in Thailand. Hepatology, 48: 1062–1069. doi: 10.1002/hep.22462

Author Information

  1. 1

    National Centre in HIV Epidemiology and Clinical Research, University of New South Wales, Sydney, Australia

  2. 2

    HIV–Netherlands Australia Thailand Red Cross AIDS Research Centre, Bangkok, Thailand

  3. 3

    Infectious Diseases Unit, The Alfred Hospital, Melbourne, Australia

  4. 4

    Department of Medicine, Monash University, Melbourne, Australia

  5. 5

    Division of Gastroenterology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand

  6. 6

    Victorian Infectious Diseases Service, Royal Melbourne Hospital, Melbourne, Australia

  7. 7

    Victorian Infectious Diseases Reference Laboratory, Melbourne, Australia

  8. 8

    Division of Allergy and Clinical Immunology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand

  1. ‡

    These authors contributed equally to this study.

  2. §

    fax: (61)-2-9385-0876

*Viral Hepatitis Program, National Centre in HIV Epidemiology and Clinical Research, University of New South Wales, 376 Victoria Street, Darlinghurst, Sydney, NSW 2010, Australia

  1. †

    Potential conflict of interest: Dr. Ruxrungtham advises, is on the speakers' bureau of and received grants from MSD Pharmaceuticals. He is on the speakers' bureau of and received grants from GlaxoSmithKline. He also received grants from Gilead. Dr. Dore advises, is on the speakers' bureau of, and received grants from Gilead. Dr. Locarnini is a consultant for, advises, and received grants fro, Evivar Pty Ltd and Gilead. He is a consultant for and owns stock in Pharmasset. He is also a consultant for Bristol-Myers Squibb. He holds intellectual property rights for and receipt royalties from Melbourne Health. Dr. Sasadeusz is a consultant for, is on the speakers' bureau of, and received grants from Gilead. Dr. Cooper advises, is on the speakers' bureau of, and received grants from Gilead.

Publication History

  1. Issue published online: 26 SEP 2008
  2. Article first published online: 11 AUG 2008
  3. Manuscript Accepted: 3 JUN 2008
  4. Manuscript Received: 4 MAR 2008

Funded by

  • Gilead Sciences. Grant Number: Clinical trial number NCT00192595

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Abstract

Coinfection with human immunodeficiency virus (HIV) and hepatitis B virus (HBV) is associated with considerable liver disease morbidity and mortality. Emerging HIV epidemics in areas of high HBV endemicity such as Asia are expanding the population with HIV/HBV coinfection. Limited randomized trial data exist to support current guidelines for HBV combination therapy in HIV/HBV coinfection. The objective of this prospective randomized clinical trial was to compare the strategy of HBV monotherapy with lamivudine (LAM) or tenofovir disoproxil fumarate (TDF) versus HBV combination therapy with LAM/TDF in antiretroviral-naïve HIV/HBV-coinfected subjects in Thailand. Thirty-six HIV/HBV-coinfected subjects initiating highly active antiretroviral therapy (HAART) were randomized to either LAM (arm 1), TDF (arm 2), or LAM/TDF (arm 3) as HBV-active drugs within HAART. At week 48, time-weighted area under the curve analysis revealed that the median HBV DNA reduction from baseline was 4.07 log10 c/mL in arm 1, 4.57 log10 c/mL in arm 2, and 4.73 log10 c/mL in arm 3 (P = 0.70). HBV DNA suppressed to <3 log10 c/mL in 46% in arm 1, 92% in arm 2, and 91% in arm 3 (P = 0.013, intent-to-treat analysis). HBV-resistant changes were detected in two subjects, both in arm 1. Hepatitis B e antigen (HBeAg) loss was observed in 33% of HBeAg-positive subjects, and 8% experienced hepatitis B surface antigen loss. Hepatic flare was observed in 25% of subjects. Conclusion: LAM monotherapy resulted in a greater proportion of subjects with HBV DNA >3 log10 c/mL at week 48 and in early resistance development. This study confirms current treatment guidelines that recommend a TDF-based regimen as the treatment of choice for HIV/HBV coinfection, but does not demonstrate any advantage of HBV combination therapy in this short-term setting. (HEPATOLOGY 2008.)

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