Ethical and practical considerations for cell and gene therapy toward an HIV cure: findings from a qualitative in-depth interview study in the United States

Karine Dubé^{1

2}, John Kanazawa³, Hursch Patel³, Michael Louella⁴, Laurie Sylla⁴, Jeff Sheehy⁵, Lynda Dee^{6

7}, Jeff Taylor^{7

8}, Jen Adair^{9

10}, Kim Anthony-Gonda¹¹, Boro Dropulić¹¹, John A Sauceda¹², Michael J Peluso¹³, Steven G Deeks¹³, Jane Simoni¹⁴

Affiliations

¹ Gillings School of Global Public Health, University of North Carolina Chapel Hill, 4108 McGavran-Greenberg Hall, Chapel Hill, NC, 27599, USA. karine_dube@med.unc.edu.
² UNC Gillings School of Global Public Health, 4108 McGavran-Greenberg Hall, Chapel Hill, NC, 27516, USA. karine_dube@med.unc.edu.
³ Gillings School of Global Public Health, University of North Carolina Chapel Hill, 4108 McGavran-Greenberg Hall, Chapel Hill, NC, 27599, USA.
⁴ defeatHIV Collaboratory, 1100 Fairview Avenue North, E5-110, Seattle, WA, 98109, USA.
⁵ Independent Consultant, 1999 Harrison Street, Suite 1650, Oakland, CA, 94612, USA.
⁶ AIDS Action Baltimore, 14 East Eager Street, Baltimore, MD, 21202, USA.
⁷ Delaney AIDS Research Enterprise (DARE) Community Advisory Board (CAB), 995 Potrero Avenue, San Francisco, CA, 94110, USA.
⁸ HIV + Aging Research Project - Palm Springs (HARP-PS), 1775 East Palm Canyon Drive, Suite 110-349, Palm Springs, CA, 92264, USA.
⁹ Fred Hutchinson Cancer Research Center, 1100 Fairview Avenue N, Seattle, WA, USA.
¹⁰ Division of Medical Oncology, Department of Laboratory Medicine and Pathology, University of Washington, 825 Eastlake Ave E, Seattle, WA, USA.
¹¹ Caring Cross, 708 Quince Orchard Road, Suite 250D, Gaithersburg, MD, USA.
¹² Department of Medicine, Division of Prevention Science, Center for AIDS Prevention Studies (CAPS), University of California, San Francisco (UCSF), 550 16th Street, 3rd Floor, San Francisco, CA, 94158, USA.
¹³ Department of Medicine, Division of HIV, Infectious Diseases, and Global Medicine, University of California, San Francisco (UCSF), San Francisco General Hospital, Ward 84, Building 80, San Francisco, CA, 94110, USA.
¹⁴ Departments of Psychology and Global Health, University of Washington, 3909 Stevens Way CE, Box 351525, Seattle, WA, USA.

PMID: 35397551
PMCID: PMC8994300
DOI: 10.1186/s12910-022-00780-1

Ethical and practical considerations for cell and gene therapy toward an HIV cure: findings from a qualitative in-depth interview study in the United States

Karine Dubé et al. BMC Med Ethics. 2022.

. 2022 Apr 9;23(1):39.

doi: 10.1186/s12910-022-00780-1.

Authors

Affiliations

¹ Gillings School of Global Public Health, University of North Carolina Chapel Hill, 4108 McGavran-Greenberg Hall, Chapel Hill, NC, 27599, USA. karine_dube@med.unc.edu.
² UNC Gillings School of Global Public Health, 4108 McGavran-Greenberg Hall, Chapel Hill, NC, 27516, USA. karine_dube@med.unc.edu.
³ Gillings School of Global Public Health, University of North Carolina Chapel Hill, 4108 McGavran-Greenberg Hall, Chapel Hill, NC, 27599, USA.
⁴ defeatHIV Collaboratory, 1100 Fairview Avenue North, E5-110, Seattle, WA, 98109, USA.
⁵ Independent Consultant, 1999 Harrison Street, Suite 1650, Oakland, CA, 94612, USA.
⁶ AIDS Action Baltimore, 14 East Eager Street, Baltimore, MD, 21202, USA.
⁷ Delaney AIDS Research Enterprise (DARE) Community Advisory Board (CAB), 995 Potrero Avenue, San Francisco, CA, 94110, USA.
⁸ HIV + Aging Research Project - Palm Springs (HARP-PS), 1775 East Palm Canyon Drive, Suite 110-349, Palm Springs, CA, 92264, USA.
⁹ Fred Hutchinson Cancer Research Center, 1100 Fairview Avenue N, Seattle, WA, USA.
¹⁰ Division of Medical Oncology, Department of Laboratory Medicine and Pathology, University of Washington, 825 Eastlake Ave E, Seattle, WA, USA.
¹¹ Caring Cross, 708 Quince Orchard Road, Suite 250D, Gaithersburg, MD, USA.
¹² Department of Medicine, Division of Prevention Science, Center for AIDS Prevention Studies (CAPS), University of California, San Francisco (UCSF), 550 16th Street, 3rd Floor, San Francisco, CA, 94158, USA.
¹³ Department of Medicine, Division of HIV, Infectious Diseases, and Global Medicine, University of California, San Francisco (UCSF), San Francisco General Hospital, Ward 84, Building 80, San Francisco, CA, 94110, USA.
¹⁴ Departments of Psychology and Global Health, University of Washington, 3909 Stevens Way CE, Box 351525, Seattle, WA, USA.

PMID: 35397551
PMCID: PMC8994300
DOI: 10.1186/s12910-022-00780-1

Abstract

Background: HIV cure research involving cell and gene therapy has intensified in recent years. There is a growing need to identify ethical standards and safeguards to ensure cell and gene therapy (CGT) HIV cure research remains valued and acceptable to as many stakeholders as possible as it advances on a global scale.

Methods: To elicit preliminary ethical and practical considerations to guide CGT HIV cure research, we implemented a qualitative, in-depth interview study with three key stakeholder groups in the United States: (1) biomedical HIV cure researchers, (2) bioethicists, and (3) community stakeholders. Interviews permitted evaluation of informants' perspectives on how CGT HIV cure research should ethically occur, and were transcribed verbatim. We applied conventional content analysis focused on inductive reasoning to analyze the rich qualitative data and derive key ethical and practical considerations related to CGT towards an HIV cure.

Results: We interviewed 13 biomedical researchers, 5 community members, and 1 bioethicist. Informants generated considerations related to: perceived benefits of CGT towards an HIV cure, perceived risks, considerations necessary to ensure an acceptable benefit/risk balance, CGT strategies considered unacceptable, additional ethical considerations, and considerations for first-in-human CGT HIV cure trials. Informants also proposed important safeguards to developing CGT approaches towards an HIV cure, such as the importance of mitigating off-target effects, mitigating risks associated with long-term duration of CGT interventions, and mitigating risks of immune overreactions.

Conclusion: Our study identified preliminary considerations for CGT-based HIV cure across three key stakeholder groups. Respondents identified an ideal cure strategy as one which would durably control HIV infection, protect the individual from re-acquisition, and eliminate transmission to others. Known and unknown risks should be anticipated and perceived as learning opportunities to preserve and honor the altruism of participants. Preclinical studies should support these considerations and be transparently reviewed by regulatory experts and peers prior to first-in-human studies. To protect the public trust in CGT HIV cure research, ethical and practical considerations should be periodically revisited and updated as the science continues to evolve. Additional ethics studies are required to expand stakeholder participation to include traditionally marginalized groups and clinical care providers.

Keywords: Cell and gene therapy; Empirical ethics research; HIV; HIV cure research; People living with HIV.

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Conflict of interest statement

K.D. provides socio-behavioral and ethics support to the California Institute of Regenerative Medicine (CIRM)/City of Hope, the defeatHIV Collaboratory (UM1 AI126623) and the BEAT-HIV Collaboratory (UM1AI126620). K.D. has ongoing socio-behavioral sciences and ethics collaborations with the Delaney AIDS Research Enterprise (UM1AI126611). S.G.D. reports Grants and/or personal fees from Gilead Sciences, Merck & Co, and ViiV, consulting fees from AbbVie, and serves on the Scientific Advisory Board of Enochian BioSciences. S.D.G. also has a Grant from CIRM to perform a CAR-T cell study and assists a non-profit (Caring Cross) focused on addressing global CGT equity. Remaining authors have no competing interest.

References

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Ethical and practical considerations for cell and gene therapy toward an HIV cure: findings from a qualitative in-depth interview study in the United States

Affiliations

Ethical and practical considerations for cell and gene therapy toward an HIV cure: findings from a qualitative in-depth interview study in the United States

Authors

Affiliations

Abstract

Conflict of interest statement

References

Publication types

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources

Medical