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Priorities for Drug Optimization

Priorities for Drug Optimization. 1. Funding needs for HIV is expected to grow significantly. Funding needs for HIV is expected to grow significantly. Lofty treatment goals and new prevention approaches make this an exciting time for HIV treatment….

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Priorities for Drug Optimization

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  1. Priorities for Drug Optimization 1

  2. Funding needs for HIV is expected to grow significantly Funding needs for HIV is expected to grow significantly Lofty treatment goals and new prevention approaches make this an exciting time for HIV treatment… Many countries already adopting emerging products in treatment protocols Treatment: 3 by ‘05 to 15 by ’15 Treatment 2.0 Better drugs and regimens Better diagnostics Turning the tide - Prevention: Microbicide gel Oral PrEP Source: AIDS 2031

  3. Funding needs for HIV is expected to grow significantly Funding needs for HIV is expected to grow significantly …But a looming funding gap threatens continued scale up of ART Many countries already adopting emerging products in treatment protocols Resources for HIV have grown considerably over the past 10 years… …but given limited scope for growth, a funding gap is looming Funding to date for HIV (USD billions) Projected needs (USD billions) Source: AIDS 2031

  4. Many countries already adopting emerging products in treatment protocols The Use of Newer, Better Therapeutics is Adding Additional Pressure to Systems # Patients on TDF in Generic Accessible Countries 5M 4.3M 3.4M 2.4M 1.6M .7M Note: Generic inaccessible markets include Argentina, Brazil, China, and MexicoSource: GLOPRO forecasting model, CHAI country teams

  5. Optimizing ARV Regimens is an Important Approach to Improving Care While Reducing Costs • Long term: Game-changers • 5-10 years to market • Objective: Develop new products that could change the landscape of HIV treatment • Short term: Value for Money • 1-3 years to market • Objective: Chose the best products we have and make them less expensive • Medium term: Dose Optimization • 3-5 years to market • Objective: Reduce the dose of drugs we have $ $ 5

  6. Short term: Value for money • Short term: Value for Money • 1-3 years to market • Objective: Chose the best products we have and make them less expensive • Approaches • Use solid evidence to select best regimens • Consolidate volumes • More efficient manufacturing technology (Chemistry and sourcing) • TDF, EFV, ATV, LPV, DRV, Pediatric formulations $ $ 6

  7. Does it work? TDF example LOWER PRICES OF TENOFOVIR RESULTED FROM SEVERAL STRATEGES Price Reduction for TDF From 2006 to 2010 (per patient per year) $207 - $60 New suppliers - $34 Cheaper inputs - $26 New process $87 2006 Price 2010 Price 58% price reduction for TDF from (from $207 in 2006 to $87 in 2010)

  8. Medium term: Dose reduction • Short term: Value for Money • 1-3 years to market • Objective: Chose the best products we have and make them less expensive • Medium term: Dose Optimization • 3-5 years to market • Objective: Reduce the dose of drugs we have • Approaches • Dose optimization – Phase III studies to demonstrate equivalent efficacy and equal or better tolerability • Reformulation – use novel formulation technology to increase amount of drug reaching its target • EFV, TDF, AZT, ATV/r, DRV/r $ $ 8

  9. Long term: Novel transformative drugs and formulations • Long term: Game-changers • 5-10 years to market • Objective: Develop new products that could change the landscape of HIV treatment • Short term: Value for Money • 1-3 years to market • Objective: Chose the best products we have and make them less expensive • Medium term: Dose Optimization • 3-5 years to market • Objective: Reduce the dose of drugs we have • Approaches • Catalyze the development of new drugs that represent a transformation in treatment • Question everything • RIL, DLG, CMX-157, GS-7340, GSK-744 $ $ 9

  10. How do we set our priorities for optimization? WHO treatment guidelines, Consensus meetings convened by WHO and UNAIDS Expert consultations such as the Conference on Antiretroviral Drug Optimization Ongoing process as new data and drugs become available Set a short-list of top priorities

  11. The result: A set of short-term priorities and a process for setting medium and long term goals Treatment 2.0 Blueprint & ARV Short Term Priorities on ARV Optimization Priorities: 1st line: Optimize TDF/3TC/EFV FDC tablet 2nd line: Develop and optimize ATV/r FDC Pediatrics: LPV/r sprinkle, RTV 25mg, AZT/3TC and ABC/3TC dispersible, scored adult TDF FDC

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