1. Modeling Studies in AIDS Vaccine R&D 1 Arne Naeveke Executive Director Advocacy, Policy and Communications IAEN – AIDS 2014 Pre-conference – July 19, 2014, Melbourne, Australia

2. Our objectives for modeling in AIDS vaccine R&D Demonstrate the impact of an AIDS vaccine in accelerating progress in the global HIV response Quantify the influence of different product characteristics on the impact and cost-effectiveness of an AIDS vaccine 2

3. Major Obstacles to ‘Getting to Zero’ Persist There are still 2.1M new infections every year (2013) Rates are still growing in specific populations and regions Access, enrollment and adherence to available prevention and treatment remains challenging for specific populations and regions Annual funding in LICs/MICs is currently falling $3-5B short of the $22-24B needed to fully scale up existing tools (2013) 3

4. A Vaccine Is Needed to “Get Close to Zero” Potential impact of an AIDS vaccine as part of the UNAIDS Enhanced Investment Framework, IFE Modeling project – UNAIDS, Futures Institute, IAVI, AVAC [funded by USAID] 4 22.5M 16.0M 7.4M Cumulative infections avoided 2011-50 New HIV Infections * An illustrative vaccine with an assumed efficacy of 60%, not representative of any specific candidate in development. Coverage reaches 70% in generalized HIV/AIDS epidemics, 60% in concentrated epidemics.

5. 5 A Vaccine Used in Combination with Other NPTs Achieves Most Dramatic and Quickest Impact Modeling project – UNAIDS, Futures Institute, IAVI, AVAC [funded by USAID] Vaccine efficacy 60% and vaccination coverage 70%/60% in generalized/concentrated epidemics New HIV Infections – NPTs added to full scale up of Investment Framework Enhanced (IFE)

6. The Impact of a Vaccine Will Be Highly Dependent on Its Efficacy 6 Modeling project – UNAIDS, Futures Institute, IAVI, AVAC [funded by USAID] Vaccination coverage reaches 70%/60% in generalized/concentrated HIV/AIDS epidemics New infections at varying vaccine efficacy levels – IFE full scale-up

7. 7 Total Cost Per Regimen will be Key to Achieving Cost-effectiveness in LICs and Lower MICs Cost($)/QALY 1200 3800 Lower MICs LICs Modeling project – UNAIDS, Futures Institute, IAVI, AVAC [funded by USAID] Vaccine efficacy 60% and vaccination coverage 70%/60% in generalized/concentrated epidemics. CE definitions and categories from according to the Word Development Indicators (WDI) of the World Bank.

8. 8 Lower Cost Per Regimen is Even More Important at Lower Efficacy Levels Cost($)/QALY 1200 3800 Lower MICs LICs Modeling project – UNAIDS, Futures Institute, IAVI, AVAC [funded by USAID] Vaccination coverage 70%/60% in generalized/concentrated epidemics. CE definitions and categories according to the Word Development Indicators (WDI) of the World Bank.

9. Preliminary Conclusions from Impact Modeling An AIDS vaccine is needed in combination with other prevention approaches to truly achieve and sustain the end of AIDS A modestly effective vaccine does reduce new infections significantly, but a highly effective vaccine is needed to get “close to zero” and to provide the cost-effectiveness needed to support broad access Cost per regimen is a critical factor to achieve acceptable cost-effectiveness in low and middle income countries, particularly at lower efficacy levels 9

10. Next steps Refine and finalize cost per regimen assumptions “Stress-test” coverage assumptions Complete calculations of the influence of variables on impact and cost-effectiveness Further update as the epidemic and the response evolve 10