the innovation & access gaps and challenges for hiv/aids under the treatment 2.0 framework
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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 - PowerPoint PPT PresentationTRANSCRIPT
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Proposals for a Global Innovation System that Responds to Patients Needs and Ensures both Innovation and AccessIAC –22 July 2012
The innovation & access gaps and challenges for HIV/AIDS under the Treatment 2.0 framework
Mariângela SimãoRights, Gender and
Community Mobilization DepartmentUNAIDS
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Global summary of the AIDS epidemic 2011
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
TotalAdults
WomenChildren (<15 years)
TotalAdults
Children (<15 years)
TotalAdults
Children (<15 years)
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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
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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.
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Prices of first-line and second-line ARV regimens for adults in low-income countries, 2008–2011
Source: Global Price Reporting Mechanism, World Health Organization, 2012.
FIRST-LINE REGIMENS
SECOND-LINE REGIMENS
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The future is happening right now
Migration from 1st to 2nd LineRegion Annual Rate of Migration
Africa 2.6%
Latin America 2.6%
South-East Asia 1.1%
Western Pacific 1.1%
Other Regions 1.9%
Countries using routine viral load monitoring
6.0%
Source: Systematic review by WHO and Australian National Centre in HIV Epidemiology and Clinical Research (CROI 2010)
Long term treatment programs – 25-30% patients on 2nd line
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Can treatment be more accessible, affordable, simple and efficient?
The right drugs available at the right place and time….
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Treatment 2.0 – a programmatic approach
TREATMENT2.0
Adapt delivery systems
Mobilize communities
POC and other
simplified monitoring
Optimize drug
regimens
Reduce costs
Five pillars
Achieve and sustain universal access & maximize the preventive benefits of ART
Simplification
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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
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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. XIXInternational 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 isembargoed until 15:00 (U.S. Eastern Standard Time) on Sunday, 22 July 2012; (iv) Viegas Neves 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.
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Optimization Strategy
Rationale What is critically needed
Major challenges & risks
Fixed-Dose Combinations
Combining existing compatible ARV drugs in one pill or co-blister improve adherence and simplify treatment
Bioequivalence studies Register results
Lab-development and testingRegulatory issuesMarket fragmentation
ARV Dose Reduction
A lower dose of a given ARV drug may have the same effect on treating the disease, at lower cost /lower side effects
Clinical trials (efficacy)Publish/register resultsDosing guidelines
Clinical trials very expensiveRegulatory issuesEthical concernsPerception concernsMarket confusion
Reformulation (eg; extended release formulations)
New formulation of an existing ARV drug can give equal level of drug in the body/blood, while taking lower dose
Bioequivalence studies Register resultsDosing guidelines
Lab-development and testingClinical trials less expensivePerception concernsMarket confusion
New Drugs & Combinations
New drug with a different profile will replace a previous component in the drug regimen, with improvement of efficacy, tolerability or convenience
Clinical trials (safety and efficacy)
Clinical trials very expensiveMarket fragmentation
New ART Strategies (eg: Induction-maintenance)
Phased approach with a short/periodic induction using combined ARV drug regimen followed by a long term monotherapy for maintenance after stable viral suppression , with improvement of tolerability, convenience, cost and long term adherence
Clinical trials (efficacy) Clinical trials very expensiveEthical concernsPerception concernsMarket confusion
ART Optimization
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Addressing innovation and access to innnovation
o Improving effectiveness, tolerability and resilience of 1st line regimens
o Assessing regimen switch needs: PoC VLo New drugs in the pipeline: accelerating entry into
market of innovative productso Ensuring competition for innovative products:
licensing mechanisms and technology transfero Global R&D convention?
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Pipeline for adults’ ARVs (UNITAID)
Apricitabine
IDX-12899
Ibalizumab
Festinavir
BMS-663068
Long-acting Rilpivirine
Lersivirine
Long-acting Dolutegravir
Long-acting CMX-157
GS-7340
SPI-452
CMX-157
Therapeutic type: Attachment InhibitorIntegrase InhibitorPK boosterNNRTINRTI PI
Pre-clinical Phase I Phase IIIDiscovery Phase II
Registration Market
Long-actingElvucitibine
QuadEVG/COB/TDF/FTC
c. 2012
DRV/COB
DRV/COB/FTC/GS-7340
ATV/COB
c. 2012
CobicistatJul 2011
Dolutegravirc. 2014
Elvitegravirc. 2012
Zidovudine Dose Reduction
300 mg 200 mg bid
Efavirenz Dose Reduction
600 mg 400 mg bid
ATV/rDose Reduction
300/100 mg 200/100 mg bid
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.
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Etravirine
Rilpivirine
Atazanavir
Dolutegravir
Raltegravir
Darunavir
Tenofovir
Maraviroc
Pre-clinical Phase I Phase IIIDiscovery Phase II
Registration Market
Therapeutic type: Entry InhibitorIntegrase InhibitorPK boosterNNRTINRTI PI
EVG/COB
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.
Pipeline for paediatric ARVs (UNITAID)
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What is needed to meet the challenge of scale up?
o Radical simplification (Tx algorithm, drugs, services)
o Innovation (in drug design, diagnostics, delivery) – shorten time between development and entry into market – registration…
o Efficiency gains – service delivery
o Effectiveness and impact – coverage and early diagnosis
o Equity and affordability (at individual and system level)
o Leadership, willingness and resources to invest
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What do we stand for?
o “No one being left behind”o Different approaches to coverage – upper middle
income countries; key populations, etc
o No double standardso Simpler to use, less toxic, heat stable drugs are
good for patients no matter where they live
o People live long and better liveso Early diagnosis. Earlier treatment initiation(?)o Better drugs and monitoring kitso…………..
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Bridging the gap?