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Leading article
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

https://doi.org/10.1136/gutjnl-2016-313009

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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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    Footnotes

    • Contributors JS and SRL designed and conceived this manuscript. All authors were involved in the analysis and interpretation of data. JS wrote the initial version of the manuscript. All authors provided critical revisions of the manuscript and approved of its final submission.

    • Funding This work was partly supported by the National Health and Medical Research Council (NHMRC) of Australia; SRL is an NHMRC Practitioner Fellow.

    • Competing interests JS receives fees for travel and expenses as a member of the Merck KGaA Stem Cell Research Oversight Committee and Bioethics Advisory Panel; receives fees for travel and expenses as a member of the Quintiles Ethics Advisory Panel and received fees from Novartis for his role as a consultant on bioethics issues. PR received research funding from Gilead Sciences. FZ received consulting fees from Roche, Gilead Sciences, Janssen, Arbutus, Contravir; and research grants from Roche, Gilead Sciences, Janssen, Sanofi and Assembly Bioscience. YY has received travel grants, honoraria for presentations at workshops and consultancy honoraria from AbbVie, Bristol-Myers Squibb, Gilead Sciences, Merck, Johnson & Johnson and ViiV Healthcare. HLAJ received grants from AbbVie, Bristol-Myers Squibb, Gilead Sciences, Innogenetics, Janssen, Medimmune, Merck, Novartis and Roche; and he is a consultant for AbbVie, Benitec, Bristol-Myers Squibb, Gilead Sciences, GSK, Janssen, Medimmune, Merck, Novartis, Roche and Arbutus. SGL is on advisory boards for Abbott, Gilead Sciences, Novartis, Merck Sharpe and Dohme, Bristol-Myers Squibb and AbbVie; he is on speakers' bureaus for Abbott, Bristol-Myers Squibb. Novartis, Roche, Gilead Sciences, AbbVie and receives educational/research funding from Abbott, Bristol-Myers Squibb, Merck Sharpe and Dohme, Gilead Sciences. SRL's institution has received funding from the National Health and Medical Research Council of Australia, National Institutes for Health, American Foundation for AIDS Research; Merck, ViiV Healthcare, Gilead Sciences and Tetralogic for investigator initiated research and Merck, ViiV Healthcare and Gilead Sciences for educational activities.

    • Provenance and peer review Not commissioned; externally peer reviewed.