June 2, 2017
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.
The full article, titled, “’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 by the journal 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 Karine Dubé, DrPH, research assistant professor in the Public Health Leadership Program in the Gillings School. “Analytical treatment interruptions are one way to show whether investigational HIV cure strategies have produced long-term viral suppression off treatment.”
There are several ethical and social issues 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 that are latently infected with HIV but are not actively producing new HIV).
This empirical study was one of the first to examine the perspectives of various stakeholders – people living with HIV, clinician-researchers and policy-makers/bioethicists – related to ATIs.
Dubé and study protocol chair Sandra B. Greene, DrPH, professor of the practice of health policy and management at UNC Gillings, found several key topics in their stakeholder interviews. First, there was little agreement on when ATIs would be ethically warranted. 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 messaged 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 properly informed 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.
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.”