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UNAIDS Strategic Direction 2 Treatment 2.0 Catalysing the next phase of treatment, care & support. Access to health as a right Social justice and equity Access to medicines: TRIPs; DOHA Resources: TGF and PEPFAR

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slide1
UNAIDS Strategic Direction 2

Treatment 2.0

Catalysing the next phase

of treatment, care & support

slide2
Access to health as a right

Social justice and equity

Access to medicines: TRIPs; DOHA

Resources: TGF and PEPFAR

AIDS transformed from a “death sentence” to a “chronic condition”

AIDS epidemic 30 years – what has changed?

slide3

AIDS epidemic 30 years – where are we now?

Global commitment to Universal Access

MDGs – taking AIDS out of isolation; convergence and integration with other health outcomesClear additional prevention benefits of treatment

New products and medicines; and simplified approaches

Changing financial environment - Global Funding crisiswith imperative to find efficiencies and savings

treatment 2 0
Treatment 2.0

Senior policy maker brainstorming meeting in June 2010

Concept launched in 2010 July by Michel Sidibe

Revamping the Public Health Approach to ART

Now a joint initiative – UNAIDS and WHO, with other partners

Core principle – universal access to treatment as a right

treatment 2 0 radical simplification of hiv treatment
Past

Large pill burden; toxic regimes

Emergency treatment (when sick)

Doctor based, nurse supported

Reliance on health facilities

5 million on treatment

Treatment versus prevention

Exponentially rising costs

Future

Low dose, less-toxic FDC regimens

Early initiation and chronic care

Nurse based, community supported

Increased autonomy and adherence

15 million on treatment (2010 needs)

Treatment as support to prevention

Sustainable financing

Treatment 2.0: radical simplification of HIV treatment
treatment 2 0 5 work streams
I - Optimize drug regimens

II – Promote point of care and simplified diagnostics

III – Reduce costs

IV – Strengthen delivery systems

V – Mobilize communities,

protect human rights

Treatment 2.0: 5 work streams
i optimize drug regimens a better pill
I. Optimize Drug Regimens – a better pill
  • Reduce pill burden/pill size
  • Reduce toxicity
  • Minimize drug-drug interactions
  • Minimize laboratory monitoring needs
  • Safe to use in adults, adolescents, children and pregnant women, Tb patients
  • Improved adherence & clinical outcomes (maximize time on effective 1st line therapy)
  • Improved convenience (patient and program levels, e.g )
  • Reduced costs (direct and indirect)

Lower dosage

Improved drug bioavailability

Substitution of toxic drug components with less toxic ones

Slow release formulations

Co-formulation (FDC or co-blister pack)

Use of new strategies e.g. induction-maintenance,

antiretrovirals with potential for dose optimization
Antiretrovirals with potential for dose optimization
  • _______________________________________________
  • Drug Current dose Potential optimised dose
  • _______________________________________________________
  • AZT 300mg BID 200 mg BID
  • d4T 30/40mg BID 10/20mg BID
  • 3TC 300 mg OD 150 mg OD
  • EFV 600 mg OD 400 mg OD
  • LPV/r 400/100 mg BID 200/100 or 200/150 mg BID
  • ATV/r 300/100 mg OD 300/50 or 200/50 mg OD
  • DRV/r 600/100 BID 400/50 mg OD
  • RTV 100mg (booster) 50mg (booster)
  • RAL 400 BID 100-200 mg BID
  • _______________________________________________

Many medicines have strong potential for dose-optimisation, providing

equivalent efficacy with an improved safety profile and lower costs

potential future areas for optimization
Potential future areas for Optimization?

Simplification of tenofovir route synthesis

Use of 3TC instead of FTC

1st Line

Reduced dosage of 3TC and EFV

Substitution of EFV for Rilpivirine or NVPxr or Lersivirine

TDF-FTC-EFV

Use of co-blister packs

Reduced dose of AZT, 3TC and LPVr

Substitution of 3TC for Apricitabine or Racivir or Elvucitabine

2nd Line

Substitution of LPVr for ATVr or DRVr

Substitution of AZT/3TC for integrase inhibitors (Raltegravir, Elvitegravir or GSK 572)

Substitution of RTV for cobicistat or SPI-452

AZT-3TC + LPVr

Maintenance with PI monotherapy

ii promote diagnostics using point of care and other simplified technologies
Rapid HIV diagnosis

Promote wider use

Improved diagnostic algorithms (beneficiary)

CD4 POC devices – some in late stages of development and evaluation

Participate in pilots where possible

Introduce as soon as commercially available

Develop guidelines and protocols

Qualitative POC paediatric viral test in development

External Quality Assurance / Quality Control for current standard and all new technologies

II. Promote diagnostics using point of care and other simplified technologies
iii reduce costs
Manufacturing - reduce costs and volume of APIs (Active Pharmaceutical ingredient) needed for ARV synthesis

Most 2nd and 3rd line ARVs and many diagnostics are under patent - reduction through improved price competition and increasing the use of TRIPS flexibilities where applicable

Streamline procurement; improve supply chain management

Non-commodity costs – account for up to 75% of ART costs: decentralised chronic care; community delivery systems, simplified monitoring protocols, task shifting

Reduce health service and user costs: earlier and improved ART will reduce morbidity thus less hospitalization, use of facilities; absenteeism and out-of-pocket expenses

III. Reduce Costs
iv adapt delivery systems
Expand opportunities for individuals to access HIV testing and counselling

Decentralize treatment initiation and maintenance to lower levels of care

Task-shifting and peer support - community systems for adherence & delivery

Integrate ART with primary care, antenatal, maternal and child health, sexual and reproductive health and drug dependence services, according to context

Strengthen procurement and supply systems to allow for increased no. of patients and maintenance at decentralized level of care/in community

Document impact and cost-effectiveness of decentralized, integrated and community based service delivery

Disseminate best practices more widely

IV. Adapt Delivery Systems
v mobilize communities
Strengthen the demand side for treatment

Engage communities in HIV testing and counselling, decentralised service delivery, adherence support and provision of care and support

Actively promote relevant “positive prevention”

Monitoring to ensure that human rights of all of people living with HIV are protected

Achieve equity in access to treatment for all; – identify those marginalised and neglected

Leadership and advocacy; revitalised activism

V. Mobilize Communities
slide15

Where we are and next steps

  • UNAIDS/WHO core working group, with ITPC and Pangaea
  • 1st meeting with all partners on 7 February 2011 (MSF, CHAI, Gates, UNITAID, PEPFAR, ANRS, NIH, GFATM, Medicines Patent Pool, NGOs); integrated action plan in preparation
  • Bilateral meetings with pharmaceutical companies – joint meeting on access standards planned at CEO level
  • WHO taking lead on health systems adaption and diagnostics
  • Community mobilization agenda, coordinated by ITPC, supported by UNAIDS
selected priority actions in asia pacific 2011
Selected priority actions in Asia Pacific 2011

Review of testing and treatment protocols Introduce WHO 2010 guidelines

Initiation < 350 CD4

TDF-based 1st line

Use of FDCs

Participate in pilots regarding new CD4 POC technologies

Decentralization and integration of ART with drug dependency treatment, TB and others programs where indicated

Support community-based treatment schemes (e.g. Pangaea project in China)

selected priority actions in asia pacific 20111
Selected priority actions in Asia Pacific 2011

Engagement with Companies (APIs and medicines) in manufacturing countries like China and India

Monitor development of new bilateral Free Trade Agreements to help prevent TRIPS+ type restrictions; DE etc

Support upcoming ITPC organized meeting with civil society in Bangkok

selected resource materials
Selected resource materials

WHO, Antiretroviral therapy for HIV infection in adults and adolescents Recommendations for a public health approach (2010 version)

Treatment 2.0: A New Prevention Paradigm in the Global Response to AIDS New York, USA, 9 June 2010, Report of the Senior Strategy Meeting

MSF, Untangling the Web of ARV Price Reductions utw.msfaccess.org, 2010

UNDP HIV/AIDS, Good Practice Guide: Improving access to treatment by utilizing public health flexibilities in the WTO TRIPS agreement, 2011

CHAI, John Hopkins University, Conference on Antiretroviral Dose Optimization, Washington DC, June 2010 - Meeting Summary & appendix

slide19

The ideal and the good

Deploying the drugs used to treat AIDS

may be the way to limit its spread

Illustration by Peter Schrank

From The Economist Nov 27th 2008

slide20
Mariangela Simão, Karl Dehne, Charles Gilks

simaom@unaids.org, dehnek@unaids.org gilksc@unaids.org

These slides are a compilation from different presentations prepared by UNAIDS, WHO, MSF and maybe others – they are public goods, no intellectual property rights... Use them as you wish