Multi-stakeholder consensus on a target product profile for an HIV cure

Abstract

Developing 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.

Figure 1

Timeline of current and future treatments and cures for HIV Current and future treatments for HIV. Current treatment for HIV is oral ART. Future options available in the next 1-3 years will probably include long acting injectable antivirals or antibodies. The timing for introduction of HIV cure strategies under investigation currently and an aspirational HIV cure strategy is unknown. ART=antiretroviral therapy.

Figure 2

Responses from stakeholders The absolute number of stakeholders that were interviewed (blue) or had email correspondence (grey) for each professional group is shown.

Figure 3

Delphi respondents by stakeholder group. The absolute number of respondents is shown according to stakeholder group

Figure 4

Delphi respondents by geography The absolute number of people who received the email and responded (blue) or declined or refused to respond (grey) to the Delphi exercise according to geographical region is shown. The geography was self-reported by survey respondents, but is an estimate based on previous information for non-respondents.