scholarly journals Ethics of HIV cure research: an unfinished agenda

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Karine Dubé ◽  
John Kanazawa ◽  
Jeff Taylor ◽  
Lynda Dee ◽  
Nora Jones ◽  
...  
Keyword(s):  
Informed Consent ◽  
Research Ethics ◽  
Scientific Uncertainty ◽  
Experimental Medicine ◽  
People Living With Hiv ◽  
Hiv Cure ◽  
Treatment Interruptions ◽  
Risk Balance ◽  
Living With Hiv ◽  
Hiv Cure Research

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.

scholarly journals Willingness to participate and take risks in HIV cure research: survey results from 400 people living with HIV in the US

2017 ◽  
Vol 3 (1) ◽  
pp. 40-71 ◽  
Author(s):  
Karine Dubé ◽  
David Evans ◽  
Laurie Sylla ◽  
Jeff Taylor ◽  
Bryan J. Weiner ◽  
...  
Keyword(s):  
People Living With Hiv ◽  
Willingness To Participate ◽  
Hiv Cure ◽  
Research Survey ◽  
The Us ◽  
Survey Results ◽  
Living With Hiv ◽  
Hiv Cure Research

scholarly journals Acceptability, motivation and the prospect of cure for people living with HIV and their healthcare providers in HIV cure-focused treatment interruption studies

2020 ◽  
Vol 17 (1) ◽  
Author(s):  
Jillian S. Y. Lau ◽  
Miranda Z. Smith ◽  
Brent Allan ◽  
Cipriano Martinez ◽  
Jennifer Power ◽  
...  
Keyword(s):  
Descriptive Analysis ◽  
Healthcare Providers ◽  
Treatment Interruption ◽  
People Living With Hiv ◽  
Hiv Cure ◽  
Educational Strategies ◽  
Analytical Treatment ◽  
Clinical Endpoints ◽  
Treatment Interruptions ◽  
Living With Hiv

Abstract Background Analytical treatment interruptions (ATI) are commonly used clinical endpoints to assess interventions aimed at curing HIV or achieving antiretroviral therapy (ART)-free HIV remission. Understanding the acceptability of ATI amongst people living with HIV (PLHIV) and their HIV healthcare providers (HHP) is limited. Methods Two online surveys for PLHIV and HHP assessed awareness and acceptability of ATI, and understanding of the prospect for HIV cure in the future. Responses were collected from July 2017–January 2018. A descriptive analysis was performed and similar questions across the two surveys were compared using χ squared test. Results 442 PLHIV and 144 HHP completed the survey. 105/400 (26%) PLHIV had ever interrupted ART, 8% of which were in a clinical trial. Altruistic motivations were drivers of participation of PLHIV in cure related research. 81/135 (60%) HHP would support their patients wishing to enrol in an HIV cure-focused trial, but fewer would promote and allow such participation (25% and 31% respectively). Compared to HHP, PLHIV were more likely to believe that an HIV cure would be achievable within 10 years (55% vs. 19%, p < 0.001), had less awareness of ATI (46% vs. 62%, p < 0.001) and were less likely to have had experience of either participation or enrolment in an ATI study (5% vs. 18%, p < 0.001) Conclusion PLHIV were more optimistic about the potential for HIV cure. HHP had more direct experience with HIV cure-focused studies. Educational strategies are required for both groups to increase understanding around ATIs in HIV cure research but should be tailored specifically to each group.

scholarly journals The significance and expectations of HIV cure research among people living with HIV in Australia

PLoS ONE ◽  
2020 ◽  
Vol 15 (3) ◽  
pp. e0229733 ◽  
Author(s):  
Jennifer Power ◽  
Gary W. Dowsett ◽  
Andrew Westle ◽  
Joseph D. Tucker ◽  
Sophie Hill ◽  
...  
Keyword(s):  
People Living With Hiv ◽  
Hiv Cure ◽  
Living With Hiv ◽  
Hiv Cure Research

scholarly journals Reply to Commentary: “Are HIV-Infected Candidates for Participation in Risky Cure-Related Studies Otherwise Healthy?”

2017 ◽  
Vol 13 (1) ◽  
pp. 23-25 ◽  
Author(s):  
Karine Dubé ◽  
Laurie Sylla ◽  
Lynda Dee
Keyword(s):  
Healthy Volunteers ◽  
Early Phase ◽  
Standard Of Care ◽  
People Living With Hiv ◽  
Hiv Cure ◽  
Acceptable Risk ◽  
Study Participants ◽  
Living With Hiv ◽  
Research Criteria ◽  
Hiv Cure Research

We respond to Eyal et al.’s commentary focusing on how people living with HIV participating in HIV cure-related studies are defined. We argue that the types of participants enrolled in research cannot be dissociated from the study interventions, the types of anticipated risks, and the background standard of care. As the field of HIV cure research advances, more nuance and granularity will be needed to define research criteria and acceptable risk/benefit ratios for cure study participants, as well as specific tiered protocol designs that serve to protect various participant populations from untoward risks, especially in very early phase research with interventions known to have potentially serious toxicities. We highlight key lessons from the ACTIVATE study involving a latency-reversing agent, Panobinostat, for HIV cure study design involving “otherwise healthy volunteers”.

scholarly journals Perceptions of HIV cure research among people living with HIV in Australia

PLoS ONE ◽  
2018 ◽  
Vol 13 (8) ◽  
pp. e0202647 ◽  
Author(s):  
Jennifer Power ◽  
Andrew Westle ◽  
Gary W. Dowsett ◽  
Jayne Lucke ◽  
Joseph D. Tucker ◽  
...  
Keyword(s):  
People Living With Hiv ◽  
Hiv Cure ◽  
Living With Hiv ◽  
Hiv Cure Research

scholarly journals Acceptability, motivation and the prospect of cure for people living with HIV and their healthcare providers in HIV cure-focused treatment interruption studies

2020 ◽  
Author(s):  
Jillian SY Lau ◽  
Miranda Z Smith ◽  
Brent Allan ◽  
Cipriano Martinez ◽  
Jennifer Power ◽  
...  
Keyword(s):  
Descriptive Analysis ◽  
Healthcare Providers ◽  
Treatment Interruption ◽  
People Living With Hiv ◽  
Hiv Cure ◽  
Educational Strategies ◽  
Analytical Treatment ◽  
Clinical Endpoints ◽  
Treatment Interruptions ◽  
Living With Hiv

Abstract Background Analytical treatment interruptions (ATI) are commonly used clinical endpoints to assess interventions aimed at curing HIV or achieving antiretroviral therapy (ART)-free HIV remission. Understanding the acceptability of ATI amongst people living with HIV (PLHIV) and their HIV healthcare providers (HHP) is limited. Methods Two online surveys for PLHIV and HHP assessed awareness and acceptability of ATI, and understanding of the prospect for HIV cure in the future. Responses were collected from July 2017-January 2018. A descriptive analysis was performed and similar questions across the two surveys were compared using χ squared test. Results 442 PLHIV and 144 HHP completed the survey. 105/400 (26%) PLHIV had ever interrupted ART, 8% of which were in a clinical trial. Altruistic motivations were drivers of participation of PLHIV in cure related research. 81/135 (60%) HHP would support their patients wishing to enrol in an HIV cure-focused trial, but fewer would promote and allow such participation (25% and 31% respectively). Compared to HHP, PLHIV were more likely to believe that an HIV cure would be achievable within 10 years (55% vs 19%, p<0.001), had less awareness of ATI (46% vs 62%,p<0.001) and were less likely to have had experience of either participation or enrolment in an ATI study (5% vs 18%,p<0.001) Conclusion PLHIV were more optimistic about the potential for HIV cure. HHP had more direct experience with HIV cure-focused studies. Educational strategies are required for both groups to increase understanding around ATIs in HIV cure research but should be tailored specifically to each group.

Reconceptualising risk–benefit analyses: the case of HIV cure research

2019 ◽  
Vol 46 (3) ◽  
pp. 212-219 ◽  
Author(s):  
Robert Steel
Keyword(s):  
Third Parties ◽  
People Living With Hiv ◽  
Hiv Cure ◽  
Ethical Justification ◽  
Antiretroviral Therapies ◽  
Regulatory Limits ◽  
Way Of Thinking ◽  
Living With Hiv ◽  
Hiv Cure Research ◽  
Substantial Interest

Modern antiretroviral therapies (ART) are capable of suppressing HIV in the bloodstream to undetectable levels. Nonetheless, people living with HIV must maintain lifelong adherence to ART to avoid the re-emergence of the infection. So despite the existence and efficacy of ART, there is still substantial interest in development of a cure. But HIV cure trials can be risky, their success is as of yet unlikely, and the medical gain of being cured is limited against a baseline of ART access. The medical prospect associated with participation in cure research thus look poor. Are the risks and burdens that HIV cure research places on participants so high that it is unethical, at present, to conduct it? In this paper, I answer ‘no’. I start my argument by describing a foundational way of thinking about the ethical justification for regulatory limits on research risk; I then apply this way of thinking to HIV cure trials. In offering this analysis, I confine my attention to studies enrolling competent adults and I also do not consider risks research may pose to third parties or society. Rather, my concern is to engage with the thought that some trials are so risky that performing them is an ethically unacceptable way to treat the participants themselves. I reject this thought and instead argue that there is no level of risk, no matter how high, that inherently mistreats a participant.

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