Abstract
SummaryDeveloping a cure for HIV is a global priority. Target product profiles are a tool commonly used throughout the drug development process to align interested parties around a clear set of goals or requirements for a potential product. Three distinct therapeutic modalities (combination therapies, ex-vivo gene therapy, and in-vivo gene therapy) for a target product profile for an HIV cure were identified. Using a process of expert face-to-face consultation and an online Delphi consultation, we found a high degree of agreement regarding the criteria for the optimum target product profile. Although the minimum attributes for a cure were debated, the broad consensus was that an acceptable cure need not be as safe and effective as optimally delivered antiretroviral therapy. An intervention that successfully cured a reasonable fraction of adults would be sufficient to advance to the clinic. These target product profiles will require further discussion and ongoing revisions as the field matures.
Highlights
38 million people worldwide are living with HIV
Initial drafting phase The initial drafting phase was initiated on July 8, 2019, with the first virtual convening of the target product profile working group, together with a secretariat supported by the International AIDS Society and the Bill & Melinda Gates Foundation
Most fundamental, how should HIV cure be defined? Second, because of the ambitious goal of developing a curative intervention for HIV, should there be more than one target product profile,? what are the key characteristics that should be captured in HIV cure target product profiles, and what are the minimum and optimum goals for each of these characteristics?
Summary
38 million people worldwide are living with HIV. This number continues to rise, due to the effects of antiretroviral therapy (ART) on life expectancy, and a sustained and stable rate of new infections with 1·7 million people newly infected each year. 1, 2 combination ART has substantially improved the health of people living with HIV, globally only about half are receiving effective therapy. 2 Many have not yet been tested and, of those known to be living with HIV, many cannot readily access or adhere to therapy in a sustained manner.[3]. Acknowledging that a first-generation cure might be at least a decade away, we do not view curative interventions as immediately supplanting traditional approaches like ART; rather, we view curative interventions as an alter native to ART, ones that might be most approp riate for those who, for whatever reason, are not able to access or to tolerate an effective ART regime over a long period of time Viewed in this manner, the minimum criteria for an effective cure might in many ways potentially be less safe, effective, or scalable than optimally delivered ART, if the attributes of the strategy address some of the unmet needs for current therapeutic interventions. Review in the Acknowledgments section) met at the Sunnylands Summit: The Path Toward Ending HIV, which took place Feb 7–9, 2019, a target product profile working group was formed to develop target product profiles for HIV curative interventions, using three distinct processes: (1) an initial drafting phase involving the members of the working group followed by (2) an expert consultative phase with stakeholders from across the field (involving email com munication and interviews) and, in parallel, (3) a broader Delphi consultation of more than 500 invited respondents
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