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The innovation & access gaps and challenges for HIV/AIDS under the Treatment 2.0 framework

Proposals for a Global Innovation System that Responds to Patients Needs and Ensures both Innovation and Access IAC –22 July 2012. The innovation & access gaps and challenges for HIV/AIDS under the Treatment 2.0 framework . Mariângela Simão Rights, Gender and

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The innovation & access gaps and challenges for HIV/AIDS under the Treatment 2.0 framework

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  1. Proposals for a Global Innovation System that Responds to Patients Needs and Ensures both Innovation and Access IAC –22 July 2012 The innovation & access gaps and challenges for HIV/AIDS under the Treatment 2.0 framework Mariângela Simão Rights, Gender and Community Mobilization Department UNAIDS

  2. Global summary of the AIDS epidemic  2011 Total Adults Women Children (<15 years) Total Adults Children (<15 years) Total Adults Children (<15 years) 34.2 million[31.8 - 35.9 million] 30.7 million [28.6–32.2 million] 16.7 million [15.7–17.8 million] 3.4 million [3.1–3.9 million] 2.5 million [2.2 –2.8 million]2.2 million [2.0 - 2.4 million] 330 000 [280 000–380 000] 1.7 million [1.6 –1.9 million]1.5 million [1.3 –1.7 million] 230 000 [200 000–270 000] Number of people living with HIV People newly infected with HIV in 2011 AIDS deaths in 2011

  3. People receiving antiretroviral therapy versus the 2015 target and the number of AIDS-related deaths, low- and middle-income countries, 2003–2011 AIDS-related deaths Estimated range of AIDS-related deaths People receiving antiretroviral therapy 2015 Target

  4. Eligibility for antiretroviral therapy versus coverage, low- and middle-income countries, by region, 2011 The area of the larger circle represents the number of people eligible for antiretroviral therapy. The shaded circle and percentage represent coverage in 2011.

  5. Prices of first-line and second-line ARV regimens for adults in low-income countries, 2008–2011 FIRST-LINE REGIMENS SECOND-LINE REGIMENS Source: Global Price Reporting Mechanism, World Health Organization, 2012.

  6. The future is happening right now Migration from 1st to 2nd Line Long term treatment programs – 25-30% patients on 2nd line Source: Systematic review by WHO and Australian National Centre in HIV Epidemiology and Clinical Research (CROI 2010)

  7. Can treatment be more accessible, affordable, simple and efficient? The right drugs available at the right place and time….

  8. Treatment 2.0 – a programmatic approach Optimize drug regimens Mobilize communities POC and other simplified monitoring TREATMENT 2.0 Adapt delivery systems Reduce costs Five pillars Achieve and sustain universal access & maximize the preventive benefits of ART Simplification

  9. Reducing costs and increasing sustainability – collaboration? • Role for the UN supporting countries on the use of TRIPS flexibilities, access principles – guidelines, policy papers, issues briefs • Global mechanisms for IP related issues and access • Medicines Patent Pool – “ up and running” – licensing mechanisms - FDC and optimized Tx options • Ohter initiatives • UNITAID, CHAI • Local production and regulatory harmonization • Upcoming – consultation on pricing in upper middle income countries

  10. Successful country initiatives to cut the costs of ARV Note: (i) At an exchange rate of 7.40 ZAR/USD, the savings amounted to R 4.7 billion. Sources: (ii) Massive reduction in ARV prices. Johannesburg, Government of South Africa, 2010 (www.info.gov.za/speech/DynamicAction?pageid=461&sid=15423&tid=26211, accessed 15 June 2012); (iii) Mutabaazi I.I. Scaling up antiretroviral treatment using the same dollar: cost efficiency and effectiveness of TASO Uganda Pharmacy Management System of CDC-PEPFAR funded program. XIX International AIDS Conference, Washington, DC, 22–27 July 2012. Note: the content of poster discussion abstracts and poster exhibition abstracts for the XIX International AIDS Conference is embargoed until 15:00 (U.S. Eastern Standard Time) on Sunday, 22 July 2012; (iv) ViegasNeves da Silva F, Hallal R, Guimaraes A. Compulsory licence and access to medicines: economic savings of efavirenz in Brazil. XIX International AIDS Conference, Washington, DC, 22–27 July 2012. Note: the content of poster discussion abstracts and poster exhibition abstracts for the XIX International AIDS Conference is embargoed until 15:00 (U.S. Eastern Standard Time) on Sunday, 22 July2012.

  11. ART Optimization

  12. Addressing innovation and access to innnovation • Improving effectiveness, tolerability and resilience of 1st line regimens • Assessing regimen switch needs: PoC VL • New drugs in the pipeline: accelerating entry into market of innovative products • Ensuring competition for innovative products: licensing mechanisms and technology transfer • Global R&D convention?

  13. Discovery Pre-clinical Phase I Phase II Phase III Registration Market Quad EVG/COB/ TDF/FTC c. 2012 Cobicistat Jul 2011 c. 2012 Zidovudine Dose Reduction 300 mg 200 mg bid Elvitegravir c. 2012 Efavirenz Dose Reduction 600 mg 400 mg bid Dolutegravir c. 2014 ATV/r Dose Reduction 300/100 mg 200/100 mg bid PI NNRTI NRTI Attachment Inhibitor Integrase Inhibitor PK booster Therapeutic type: Pipeline for adults’ ARVs (UNITAID) DRV/COB Long-acting CMX-157 Apricitabine DRV/COB/ FTC/GS-7340 GS-7340 Long-acting Elvucitibine Festinavir Long-acting Rilpivirine ATV/COB CMX-157 Long-acting Dolutegravir Lersivirine IDX-12899 Ibalizumab SPI-452 BMS-663068 Source: Source: Adapted from 2011 i-Base/TAG Pipeline Report (available at http://i-base.info/home/2011-pipeline-report-2nd edition-september-2011) and clinicaltrials.gov.

  14. Discovery Pre-clinical Phase I Phase II Phase III Registration Market Tenofovir EVG/COB Etravirine Maraviroc Rilpivirine Atazanavir Darunavir Dolutegravir Raltegravir PI NNRTI NRTI Entry Inhibitor Integrase Inhibitor PK booster Therapeutic type: Pipeline for paediatric ARVs (UNITAID) Source: Source: Adapted from 2011 i-Base/TAG Pipeline Report (available at http://i-base.info/home/2011-pipeline-report-2nd edition-september-2011) and clinicaltrials.gov.

  15. What is needed to meet the challenge of scale up? • Radical simplification (Tx algorithm, drugs, services) • Innovation (in drug design, diagnostics, delivery) – shorten time between development and entry into market – registration… • Efficiency gains – service delivery • Effectiveness and impact – coverage and early diagnosis • Equity and affordability (at individual and system level) • Leadership, willingness and resources to invest

  16. What do we stand for? • “No one being left behind” • Different approaches to coverage – upper middle income countries; key populations, etc • No double standards • Simpler to use, less toxic, heat stable drugs are good for patients no matter where they live • People live long and better lives • Early diagnosis. Earlier treatment initiation(?) • Better drugs and monitoring kits • …………..

  17. Bridging the gap?

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