Situation Analysis:

HIV infection continues to be a major public health threat with approximately 37 million people infected worldwide. Sub-Saharan Africa bears the greatest burden with nearly 1 in 20 adults infected. The world invests approximately US$1 billion in HIV R&D, but only 10 percent of this investment focuses on cure research. The HIV Cure Initiative is an international alliance of scientific, governmental, philanthropic and industrial organizations dedicated to augmenting existing HIV cure efforts by facilitating partnerships and collaborations, advocating funding for HIV cure efforts, and disseminating information among stakeholders. To raise awareness and motivate greater cure R&D investment, the initiative sponsored a project to estimate the investment required to develop a cure (i.e., prolonged viral remission in the absence of antiretroviral therapy) and to determine the potential health impact and cost effectiveness associated with a cure.

Discovery & Solutions:

SDG’s global health subsidiary, Applied Strategies, conducted an extensive literature review to identify ongoing cure-related research, to understand populations living with and transmitting HIV, and to assess the cost and benefit of current HIV treatments. We then worked closely with initiative members and other experts to define a feasible target product profile, develop appropriate methodology, agree on key analysis assumptions, and review and refine key analysis inputs. The subsequent analysis determined the demand, health impact and cost effectiveness of a cure if it were available today and had a duration of remission of three, five, or 10 years. We then leveraged appropriate development cost and probability of success benchmarks to estimate the cost of developing at least one cure.

Results & Impact:

The R&D investment analysis concluded an investment of $5 billion to $45 billion would be needed to successfully develop a cure, depending on the characteristics of the cure regimen (e.g., drug vs. vaccine vs. combination). The demand for a cure regimen assumed the currently known HIV-positive population would be immediately cure-eligible and the undiagnosed HIV-positive population would be diagnosed and become cure-eligible over a five-year time frame. The analysis did not include future incident cases. Given these assumptions, annual demand for cure regimens was forecast to be 2 to 6 million depending on the duration of remission and number or repeat cure regimens. It was assumed that the portion of the HIV-positive population that failed cure treatment due to efficacy or adherence would return to an ART regimen for the duration of the 10-year study period. As a result, ART demand reached a steady state demand that was approximately equivalent to 2015 ART demand levels. With modest assumptions for cure regimen efficacy and adherence, the cost-benefit analysis indicated that in a single remission period, an HIV cure could save $20 billion to $90 billion on treatment costs and prevent 236,000 to 710,000 new infections due to transmission, depending on the duration of remission.

The HIV Cure Initiative is now using these results to advocate for additional cure-related R&D investment and increased industry participation in cure-related R&D.