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