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 crisis with 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 1 st 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 optimization _______________________________________________ Drug Current dosePotential optimised dose _______________________________________________________ AZT300mg BID200 mg BID d4T30/40mg BID10/20mg BID 3TC300 mg OD150 mg OD EFV600 mg OD400 mg OD LPV/r400/100 mg BID200/100 or 200/150 mg BID ATV/r300/100 mg OD300/50 or 200/50 mg OD DRV/r600/100 BID400/50 mg OD RTV 100mg (booster)50mg (booster) RAL400 BID 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 st Line 2 nd 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 2 nd 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' ClinicCommunity based Clubs Monthly doctor/nurse appointment allocated to one club Counselor and PWHLA “facilitator” Peer support Individual consultationGroup screening Time: 1 day in the clinic2 hours Monthly refills2-3 months refills General education, health talks Specific education & discussion 12 visits a year6 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 1 st 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, 2010utw.msfaccess.org 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 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 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