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

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

AIDS epidemic 30 years – what has changed?

Global commitment to Universal Access

MDGs – taking AIDS out of isolation; convergence and integration with other health outcomes

Clear additional prevention benefits of treatment

New products and medicines; and simplified approaches

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

AIDS epidemic 30 years – where are we now?

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: 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

I. Optimize Drug Regimens – a better pill

Lower dosage

Substitution of toxic drug components with less toxic ones

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

Co-formulation (FDC or co-blister pack)

Improved drug bioavailability

Slow release formulations

• Improved adherence & clinical outcomes (maximize time on effective 1st line therapy)

• Improved convenience (patient and program levels, e.g )

• Reduced costs (direct and indirect)

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

Antiretrovirals with potential

for dose optimization0 2 4 6 8 10 12 14 16

Efavirenz 200 mg + ZDV/3TC

Efavirenz 400 mg + ZDV/3TC

Efavirenz 600 mg + ZDV/3TC

0

20

40

60

80

100

Per

cent

HIV

RN

A <

400

0 2 4 6 8 10 12 14 16

Efavirenz 200 mg + ZDV/3TC

Efavirenz 400 mg + ZDV/3TC

Efavirenz 600 mg + ZDV/3TC

0

20

40

60

80

100

Per

cent

HIV

RN

A <

400

_______________________________________________Drug Current dose Potential optimised dose_______________________________________________________AZT 300mg BID 200 mg BIDd4T 30/40mg BID 10/20mg BID3TC 300 mg OD 150 mg ODEFV 600 mg OD 400 mg ODLPV/r 400/100 mg BID 200/100 or 200/150 mg BIDATV/r 300/100 mg OD 300/50 or 200/50 mg ODDRV/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?Simplification of tenofovir route synthesis

Use of 3TC instead of FTC

Reduced dosage of 3TC and EFV

Substitution of EFV for Rilpivirine or NVPxr or Lersivirine

TDF-FTC-EFV

AZT-3TC + LPVr

Reduced dose of AZT, 3TC and LPVr

Substitution of 3TC for Apricitabine or Racivir or Elvucitabine

Substitution of LPVr for ATVr or DRVr

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

Maintenance with PI monotherapy

Substitution of RTV for cobicistat or SPI-452

1st Line

2nd Line

Use of co-blister packs

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

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

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

Khayelitsha, South Africa (MSF): Facility-linked, PLWHA-led ‘Adherence Clubs'

Clinic Community based Clubs

Monthly doctor/nurse appointment

20-30 allocated to one club Counselor and PWHLA “facilitator”Peer support

Individual consultation Group screening

Time: 1 day in the clinic 2 hours

Monthly refills 2-3 months refills

General education, health talks

Specific education & discussion

12 visits a year 6 visits, with flexibility (family member can pick up meds)

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

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

• 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 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

• 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

From The Economist Nov 27th 2008

Illustration by Peter Schrank

The ideal and the good

Deploying the drugs used to treat AIDS may be the way to limit its spread

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