Transcript Treatment 2.0

UNAIDS Strategic Direction 2
Treatment 2.0
Catalysing the next phase
of treatment, care & support
AIDS epidemic 30 years – what has changed?
• 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 – where are we now?
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 crisis
with imperative to find efficiencies and savings
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
Future
Large pill burden; toxic regimes
Low dose, less-toxic FDC regimens
Emergency treatment (when sick)
Early initiation and chronic care
Doctor based, nurse supported
Nurse based, community supported
Reliance on health facilities
Increased autonomy and adherence
5 million on treatment
15 million on treatment (2010 needs)
Treatment versus prevention
Treatment as support to prevention
Exponentially rising costs
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
 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
Lower dosage
• Improved adherence & clinical
outcomes (maximize time on effective
1st line therapy)
• Improved convenience (patient and
program levels, e.g )
• Reduced costs (direct and indirect)
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
Percent HIV RNA <400
100
80
60
Efavirenz 200 mg + ZDV/3TC
40
Efavirenz 400 mg + ZDV/3TC
Efavirenz 600 mg + ZDV/3TC
20
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0
0
2
4
6
8
10
12
Drug
Current dose
Potential optimised dose
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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
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Many medicines have strong potential for dose-optimisation, providing
equivalent efficacy with an improved safety profile and lower costs
14
16
Potential future areas for Optimization?
Simplification of tenofovir route synthesis
1st
Use of 3TC instead of FTC
Line
Reduced dosage of 3TC and EFV
TDF-FTC-EFV
Substitution of EFV for Rilpivirine or NVPxr or
Lersivirine
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
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
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
Mariangela Simão, Karl Dehne, Charles Gilks
[email protected], [email protected]
[email protected]
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