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Ethics and hepatitis B cure research
  1. Jeremy Sugarman1,
  2. Peter Revill2,
  3. Fabien Zoulim3,
  4. Yazdan Yazdanpanah4,
  5. Harry L A Janssen5,
  6. Seng Gee Lim6,
  7. Sharon R Lewin7
  1. 1Berman Institute of Bioethics, Johns Hopkins University, Baltimore, Maryland, USA
  2. 2Victorian Infectious Diseases Reference Laboratory, The Royal Melbourne Hospital at the Peter Doherty Institute for Infection and Immunity, Melbourne, Australia
  3. 3INSERM, Cancer Research Center of Lyon, Hospices Civils de Lyon, Lyon University, Lyon, France
  4. 4INSERM, Infection Antimicrobials Modelling Evolution, University of Paris Diderot, Hôpital Bichat, Paris, France
  5. 5Toronto Centre for Liver Disease, University Health Network, Toronto General Hospital, Toronto, Canada
  6. 6Division of Gastroenterology and Hepatology, National University Health System, Singapore, Singapore
  7. 7The Royal Melbourne Hospital at the Peter Doherty Institute for Infection and Immunity, The University of Melbourne, Melbourne, Australia
  1. Correspondence to Dr Jeremy Sugarman, Johns Hopkins Berman Institute of Bioethics, 1809 Ashland Ave, Baltimore, MD 21205 USA; jsugarman{at}jhu.edu

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Recent scientific advances, including the development of curative therapies for HCV and the establishment of global cure initiatives for HIV, have led to international calls seeking a cure for chronic infection with HBV.1 ,2 Over 240 million people live with chronic HBV, resulting in up to 780 000 deaths annually due to hepatic fibrosis/cirrhosis and hepatocellular carcinoma (HCC).3 ,4 Persons chronically infected with HBV who do not receive treatment have a lifelong risk of developing HCC, the third most common cause of disease globally.5–7 Along with scaled-up approaches to preventing and treating chronic HBV infection, having a safe and effective cure for HBV infection promises to minimise the global burden of HBV-related morbidity and mortality and reduce the economic and other burdens of lifelong treatment. Nevertheless, as HBV cure research proceeds, it is critical to anticipate and address the associated ethical issues to best protect the rights, interests and welfare of those who participate in the research as well as those who are or will become chronically infected with HBV. In this paper, after describing briefly the rationale for work aimed at achieving HBV cure, we delineate some of the key ethical issues that are especially salient for HBV cure research: (1) risks of interventions; (2) outcome measures, monitoring and modelling; (3) selection of study population; (4) language and consent; and (5) fairness.

Seeking an HBV cure

HBV infects hepatocytes and can establish a long-lived persistent reservoir through unintegrated covalently closed circular (ccc)DNA (and to a lesser extent integrated HBV DNA) that can continually produce HBV DNA and viral proteins, particularly hepatitis B surface antigen (HBsAg).8 Following the administration of nucleos(t)ide reverse transcriptase inhibitors or interferon α, the main strategies for treating chronic HBV infection,9 ,10 HBV DNA declines to often undetectable levels and liver inflammation improves, …

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