Ethics of HIV cure research: an unfinished agenda

doi:10.1186/s12910-021-00651-1

Review

. 2021 Jun 30;22(1):83.

doi: 10.1186/s12910-021-00651-1.

Ethics of HIV cure research: an unfinished agenda

Karine Dubé¹, John Kanazawa², Jeff Taylor^{3

4

5}, Lynda Dee^{6

7}, Nora Jones⁸, Christopher Roebuck⁸, Laurie Sylla⁹, Michael Louella⁹, Jan Kosmyna¹⁰, David Kelly¹⁰, Orbit Clanton¹¹, David Palm^{5

12}, Danielle M Campbell^{7

13}, Morénike Giwa Onaiwu^{10

14}, Hursch Patel², Samuel Ndukwe², Laney Henley², Mallory O Johnson¹⁵, Parya Saberi¹⁵, Brandon Brown¹⁶, John A Sauceda¹⁵, Jeremy Sugarman¹⁷

Affiliations

¹ University of North Carolina at Chapel Hill, Gillings School of Global Public Health, 4108 McGavran-Greenberg Hall, Chapel Hill, NC, 27599-7469, USA. karine_dube@med.unc.edu.
² University of North Carolina at Chapel Hill, Gillings School of Global Public Health, 4108 McGavran-Greenberg Hall, Chapel Hill, NC, 27599-7469, USA.
³ HIV + Aging Research Project - Palm Springs (HARP-PS), Palm Springs, CA, USA.
⁴ AntiViral Research Center (AVRC) Community Advisory Board (CAB), San Diego, CA, USA.
⁵ Collaboratory of AIDS Researchers for Eradication (CARE) CAB, Chapel Hill, NC, USA.
⁶ AIDS Action Baltimore, Baltimore, MD, USA.
⁷ Delaney AIDS Research Enterprise (DARE) Community Advisory Board (CAB), San Francisco, CA, USA.
⁸ BEAT-HIV Collaboratory CAB, Philadelphia, PA, USA.
⁹ defeatHIV CAB, Seattle, WA, USA.
¹⁰ AIDS Clinical Trials Group (ACTG) Community Scientific Subcommittee (CSS) Ethics Working Group, Nationwide, USA.
¹¹ AIDS Clinical Trials Group Global CAB, Washington, D.C., USA.
¹² Institute of Global Health and Infectious Diseases HIV Treatment and Prevention CAB, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
¹³ Charles R. Drew College of Medicine and Science, Los Angeles, CA, USA.
¹⁴ Center for the Study of Women, Gender, and Sexuality (School of Humanities), Rice University, Houston, TX, USA.
¹⁵ Center for AIDS Prevention Studies (CAPS), Division of Prevention Sciences, UCSF, San Francisco, CA, USA.
¹⁶ Department of Social Medicine, Population and Public Health, Center for Healthy Communities, University of California, Riverside, Riverside, CA, USA.
¹⁷ Johns Hopkins Berman Institute for Bioethics, Baltimore, MD, USA.

PMID: 34193141
PMCID: PMC8243312
DOI: 10.1186/s12910-021-00651-1

Review

Ethics of HIV cure research: an unfinished agenda

Karine Dubé et al. BMC Med Ethics. 2021.

. 2021 Jun 30;22(1):83.

doi: 10.1186/s12910-021-00651-1.

Authors

Affiliations

¹ University of North Carolina at Chapel Hill, Gillings School of Global Public Health, 4108 McGavran-Greenberg Hall, Chapel Hill, NC, 27599-7469, USA. karine_dube@med.unc.edu.
² University of North Carolina at Chapel Hill, Gillings School of Global Public Health, 4108 McGavran-Greenberg Hall, Chapel Hill, NC, 27599-7469, USA.
³ HIV + Aging Research Project - Palm Springs (HARP-PS), Palm Springs, CA, USA.
⁴ AntiViral Research Center (AVRC) Community Advisory Board (CAB), San Diego, CA, USA.
⁵ Collaboratory of AIDS Researchers for Eradication (CARE) CAB, Chapel Hill, NC, USA.
⁶ AIDS Action Baltimore, Baltimore, MD, USA.
⁷ Delaney AIDS Research Enterprise (DARE) Community Advisory Board (CAB), San Francisco, CA, USA.
⁸ BEAT-HIV Collaboratory CAB, Philadelphia, PA, USA.
⁹ defeatHIV CAB, Seattle, WA, USA.
¹⁰ AIDS Clinical Trials Group (ACTG) Community Scientific Subcommittee (CSS) Ethics Working Group, Nationwide, USA.
¹¹ AIDS Clinical Trials Group Global CAB, Washington, D.C., USA.
¹² Institute of Global Health and Infectious Diseases HIV Treatment and Prevention CAB, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
¹³ Charles R. Drew College of Medicine and Science, Los Angeles, CA, USA.
¹⁴ Center for the Study of Women, Gender, and Sexuality (School of Humanities), Rice University, Houston, TX, USA.
¹⁵ Center for AIDS Prevention Studies (CAPS), Division of Prevention Sciences, UCSF, San Francisco, CA, USA.
¹⁶ Department of Social Medicine, Population and Public Health, Center for Healthy Communities, University of California, Riverside, Riverside, CA, USA.
¹⁷ Johns Hopkins Berman Institute for Bioethics, Baltimore, MD, USA.

PMID: 34193141
PMCID: PMC8243312
DOI: 10.1186/s12910-021-00651-1

Abstract

Background: The pursuit of a cure for HIV is a high priority for researchers, funding agencies, governments and people living with HIV (PLWH). To date, over 250 biomedical studies worldwide are or have been related to discovering a safe, effective, and scalable HIV cure, most of which are early translational research and experimental medicine. As HIV cure research increases, it is critical to identify and address the ethical challenges posed by this research.

Methods: We conducted a scoping review of the growing HIV cure research ethics literature, focusing on articles published in English peer-reviewed journals from 2013 to 2021. We extracted and summarized key developments in the ethics of HIV cure research. Twelve community advocates actively engaged in HIV cure research provided input on this summary and suggested areas warranting further ethical inquiry and foresight via email exchange and video conferencing.

Discussion: Despite substantial scholarship related to the ethics of HIV cure research, additional attention should focus on emerging issues in six categories of ethical issues: (1) social value (ongoing and emerging biomedical research and scalability considerations); (2) scientific validity (study design issues, such as the use of analytical treatment interruptions and placebos); (3) fair selection of participants (equity and justice considerations); (4) favorable benefit/risk balance (early phase research, benefit-risk balance, risk perception, psychological risks, and pediatric research); (5) informed consent (attention to language, decision-making, informed consent processes and scientific uncertainty); and (6) respect for enrolled participants and community (perspectives of people living with HIV and affected communities and representation).

Conclusion: HIV cure research ethics has an unfinished agenda. Scientific research and bioethics should work in tandem to advance ethical HIV cure research. Because the science of HIV cure research will continue to rapidly advance, ethical considerations of the major themes we identified will need to be revisited and refined over time.

Keywords: Experimental medicine; HIV cure research; People living with HIV; Research ethics.

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Conflict of interest statement

Jeremy Sugarman is a member of Merck KGaA’s Bioethics Advisory Panel and Stem Cell Research Oversight Committee; a member of IQVIA’s Ethics Advisory Panel; a member of Aspen Neurosciences Scientific Advisory Board; a member of a Merck Data Monitoring Committee; a consultant to Biogen; and a consultant to Portola Pharmaceuticals Inc. None of these activities are related to the material discussed in this manuscript. No other authors have outside interests to declare.

Figures

**Fig. 1**
PRISMA-ScR flow diagram: ethics of HIV cure-related research (2013–2021)

See this image and copyright information in PMC

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References

1. U.S. DHHS. FDA-Approved HIV Medicines [Internet]. AIDSinfo. 2020 [cited 2020 Apr 28]. Available from: https://aidsinfo.nih.gov/understanding-hiv-aids/fact-sheets/21/58/fda-ap...
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[1] U.S. DHHS. FDA-Approved HIV Medicines [Internet]. AIDSinfo. 2020 [cited 2020 Apr 28]. Available from: https://aidsinfo.nih.gov/understanding-hiv-aids/fact-sheets/21/58/fda-ap...

[2] U.S. DHHS. FDA-Approved HIV Medicines [Internet]. AIDSinfo. 2020 [cited 2020 Apr 28]. Available from: https://aidsinfo.nih.gov/understanding-hiv-aids/fact-sheets/21/58/fda-ap...

[3] Deeks SG, Lewin SR, Ross AL, Ananworanich J, Benkirane M, Cannon P, et al. International AIDS Society Global Scientific Strategy: towards an HIV Cure 2016. Nat Med. 2016;22(8):839–850. doi: 10.1038/nm.4108. - DOI - PMC - PubMed

[4] Deeks SG, Lewin SR, Ross AL, Ananworanich J, Benkirane M, Cannon P, et al. International AIDS Society Global Scientific Strategy: towards an HIV Cure 2016. Nat Med. 2016;22(8):839–850. doi: 10.1038/nm.4108. - DOI - PMC - PubMed

[5] Freedberg KA, Sax PE. Improving on effective antiretroviral therapy: how good will a cure have to be? J Med Ethics. 2017;43(2):71–73. doi: 10.1136/medethics-2016-103907. - DOI - PMC - PubMed

[6] Freedberg KA, Sax PE. Improving on effective antiretroviral therapy: how good will a cure have to be? J Med Ethics. 2017;43(2):71–73. doi: 10.1136/medethics-2016-103907. - DOI - PMC - PubMed

[7] Granich R, Gupta S, Hall I, Aberle-Grasse J, Hader S, Mermin J. Status and methodology of publicly available national HIV care continua and 90-90-90 targets: a systematic review. PLOS Med. 2017;14(4):e1002253. doi: 10.1371/journal.pmed.1002253. - DOI - PMC - PubMed

[8] Granich R, Gupta S, Hall I, Aberle-Grasse J, Hader S, Mermin J. Status and methodology of publicly available national HIV care continua and 90-90-90 targets: a systematic review. PLOS Med. 2017;14(4):e1002253. doi: 10.1371/journal.pmed.1002253. - DOI - PMC - PubMed

[9] TAG. Research Toward a Cure Trials [Internet]. 2021. Available from: http://www.treatmentactiongroup.org/cure/trials.

[10] TAG. Research Toward a Cure Trials [Internet]. 2021. Available from: http://www.treatmentactiongroup.org/cure/trials.

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Ethics of HIV cure research: an unfinished agenda

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Ethics of HIV cure research: an unfinished agenda

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