Background: We investigated perceptions of and willingness to undergo analytical treatment interruptions (ATIs) as part of HIV cure studies in the United States.
Methods: We completed a cross-sectional survey with 400 American adults living with HIV (22% females; 77% males; < 1% transgenders) in 2015. The sample was ethnically diverse and 38 U.S. states were represented. We also conducted extensive key informant interviews with 36 people living with HIV, researchers, bioethicists and regulators to assess motivations, perceptions of and concerns around ATIs.
Results: In the sample of potential HIV-positive volunteers, 98% [95% CI: 93, 100]; n = 400) were currently taking antiretrovirals. Almost half 44% [39, 49%]; n = 399) reported they had ever participated in an HIV treatment study and 7% [2, 12%]; n = 400 said they had ever been part of a HIV cure-related study. Of the survey respondents, 26% [21, 31%] were very willing to interrupt treatment, 42% [37, 47%] were somewhat willing, 12% [7, 17%] were not very willing, 9% [4, 14%] were not at all willing and 11% [6, 16%]; n = 359 were unsure. Close to two thirds (65% [60, 70%]; n = 350) reported that no more HIV treatment ever would be the definition of cure to them. Motivations for undergoing ATIs included: desire to help find a cure, past experiences with treatment interruptions and compensation. A subset of potential volunteers considered ATIs to be “too much risk” and expressed concerns about the possibility of viral rebound and development of resistance to ARVs. Clinicians-researchers and regulators were divided on the topic of ATIs. Some believed ATIs should not be attempted unless proof of concept is established for experimental modalities. Others agreed that there are criteria for proceeding with ATIs, including strong scientific justification, close monitoring and demonstrated substantial reduction in reservoir size and/or significant augmentation of the immune clearance function.
Conclusions: As a functional cure may be defined as ART-free remission, ATIs could become a clinically meaningful measure for cure. To ensure ethical utilization, it will be important to continue understanding stakeholders'' perspectives while minimizing risks.

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