Antiretroviral therapy offers well-documented benefits to people living with HIV. Why, then, would researchers ask study participants to interrupt treatment?
Recently, two faculty members from the UNC Gillings School of Global Public Health investigated how stakeholders respond to the concept of using analytical treatment interruptions (ATIs) to test the efficacy of potential HIV cure research strategies in the absence of antiretroviral therapy.
[Photo: Why would researchers ask people living with HIV to interrupt their treatment with antiretroviral therapy (ART)? Two researchers from the UNC Gillings School examine the ethical and social issues associated with “analytical treatment interruptions” to test the efficacy of potential HIV cure research strategies in the absence of ART. Photo courtesy of NIAID.]
The article, “‘We Need to Deploy Them Very Thoughtfully and Carefully’: Perceptions of Analytical Treatment Interruptions in HIV Cure Research in the United States – A Qualitative Inquiry,” was published online May 31 in AIDS Research and Human Retroviruses.
“This research is timely and important because the number of HIV cure studies is growing exponentially in the United States and around the world,” said first author Dr. Karine Dubé, research assistant professor in the Gillings School’s Public Health Leadership Program. “Analytical treatment interruptions are one way to show whether investigational HIV cure strategies have produced long-term viral suppression off treatment.”
Several ethical and social issues are associated with ATIs, including risks such as the potential for HIV drug resistance, heightened HIV transmission, and an increased HIV reservoir (dormant cells in the body latently infected with HIV but not actively producing new virus).
This empirical study was one of the first to examine perspectives of various stakeholders – people living with HIV, clinician-researchers and policy-makers/bioethicists – related to ATIs.
Dr. Dubé and study protocol chair Dr. Sandra B. Greene, Professor of the Practice of health policy and management at the UNC Gillings School, found several key topics in their stakeholder interviews. First, there was little agreement on when ATIs would be warranted ethically. Second, the most frequent “perceived hypothetical motivators” for participating in research on ATIs were advancing science and contributing to society. Third, risks related to viral rebound were the most prevalent concerns related to ATIs.
Stakeholders underscored the message that not every HIV cure study requires ATIs at this time. (Some HIV cure studies rely on sensitive assays to detect whether an HIV reservoir depletion has occurred.) Studies that do utilize ATIs must have proper safeguards in place, and participants must be informed appropriately of the risks of research. Stakeholders also suggested ways to minimize the risks of ATIs in HIV cure research, including increased cooperation between scientists, bioethicists, and local communities.
Dr. Dubé agreed.
“Increased collaboration between biomedical HIV cure scientists, social scientists, bioethicists, community representatives, and health-care providers may be needed to assess evolving perceptions around ATIs and create conditions for the responsible conduct of HIV cure research,” she said.Biostatistics and Informatics, Health Policy and Management, HIV/AIDS, UNC