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?