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Priorities for Drug Optimization

Funding needs for HIV is expected to grow significantly

Source: AIDS 2031

Treatment: 3 by ‘05 to 15 by ’15Treatment 2.0Better drugs and regimensBetter diagnostics

Turning the tide - Prevention:Microbicide gelOral PrEP

Funding needs for HIV is expected to grow significantlyMany countries already adopting emerging products in treatment protocolsLofty treatment goals and new prevention approaches make this an exciting time for HIV treatment…

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Funding needs for HIV is expected to grow significantly

Projected needs (USD billions)

Source: AIDS 2031

Funding to date for HIV (USD billions)

…but given limited scope for growth, a funding gap is looming

Resources for HIV have grown considerably over the past 10 years…

Funding needs for HIV is expected to grow significantlyMany countries already adopting emerging products in treatment protocols…But a looming funding gap threatens continued scale up of ART

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Many countries already adopting emerging products in treatment protocolsThe Use of Newer, Better Therapeutics is Adding Additional Pressure to

Systems

# Patients on TDFin Generic Accessible Countries

Note: Generic inaccessible markets include Argentina, Brazil, China, and MexicoSource: GLOPRO forecasting model, CHAI country teams

.7M

1.6M

2.4M

3.4M

4.3M5M

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Optimizing ARV Regimens is an Important Approach to Improving Care While Reducing Costs

Short term: Value for Money1-3 years to market

• Objective: Chose the best products we have and make them less expensive

Long term: Game-changers5-10 years to market

• Objective: Develop new products that could change the landscape of HIV treatment

Medium term: Dose Optimization3-5 years to market

• Objective: Reduce the dose of drugs we have

$ $

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Short term: Value for money

Short term: Value for Money1-3 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$ $

LOWER PRICES OF TENOFOVIR RESULTED FROM SEVERAL STRATEGES

Does it work? TDF example

2006 Price 2010 Price

$207

$87

Price Reduction for TDF From 2006 to 2010 (per patient per year)

- $60 New suppliers

- $34- $26

Cheaper inputsNew process

58% price reduction for TDF from (from $207 in 2006 to $87 in 2010)

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Medium term: Dose reduction

Short term: Value for Money1-3 years to market

• Objective: Chose the best products we have and make them less expensive

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

$ $

Medium term: Dose Optimization3-5 years to market

• Objective: Reduce the dose of drugs we have

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Long term: Novel transformative drugs and formulations

Short term: Value for Money1-3 years to market

• Objective: Chose the best products we have and make them less expensive

Approaches

• Catalyze the development of new drugs that represent a transformation in treatment

• Question everything

RIL, DLG, CMX-157, GS-7340, GSK-744

$ $

Medium term: Dose Optimization3-5 years to market

• Objective: Reduce the dose of drugs we have

Long term: Game-changers5-10 years to market

• Objective: Develop new products that could change the landscape of HIV treatment

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

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