A Person-Centered Cure

New study champions the needs of people living with HIV in cure trials

By Jeffrey Laurence, M.D.

Research question
Striking advances have been made in the development of diverse approaches to eradicating the HIV reservoir, the main barrier to a cure, but these studies have involved test tubes and animal models. Ultimately, the validity of these methods can only be proven in people living with HIV (PLWH) themselves.

And that requires a test—an analytic treatment interruption, or ATI—by which the person agrees to stop taking antiretroviral therapy (ART) to determine if or when HIV reappears. There is no clear marker, in blood or tissue, that can predict a durable, ART-free cure without stopping ART.

Yet little is known about the personal experiences of PLWH enrolled in cure-related trials involving extended ATIs, including psychological stressors and the need to change sexual behaviors (e.g., new requirement to use of condoms or PrEP).

Dr. Karine Dubé. Photo courtesy of the UNC Gillings School of Global Public Health
Dr. Karine Dubé. Photo courtesy of the UNC Gillings School of Global Public Health

This study involved six cisgender men and one transgender woman enrolled in a UCSF-amfAR cure trial that incorporated a prolonged ATI. The trial was complex and combined five interventions: an HIV DNA vaccine, the immune hormone IL-12, a vaccinia boost vaccine, broadly HIV neutralizing antibodies, and a drug to activate the immune protein TLR9. Five of the seven participants had some level of HIV control for at least 100 days off ART, and one of the seven had no detectable virus for 18 months off ART.

Many participants agreed to enroll as “giving back to science [was] part of a personal HIV journey.” One participant “described excitement around this trial, even claiming willingness to sacrifice his life for an HIV cure.” But then half of those interviewed described “emotional highs and lows during the ATI, coupled with periods of uncertainty about the outcome.” Four of the seven noted challenges protecting their partners from HIV during the ATI.

The authors concluded that the study findings “underscore the need for increased and dedicated efforts to support [PLWH]undergoing intensive ATI trials, particularly in the areas of mental health and partner protections.”

amfAR’s role
amfAR was a funder of this research. amfAR grantee Karine Dubé, DrPh, of the University of California, San Diego, and the University of North Carolina at Chapel Hill was the lead author of the paper.

Original article

Dr. Laurence is amfAR’s senior scientific consultant.

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