ART in Resource-limited settings : Progress and Challenges Dr. B. B. Rewari MD,FRCP,FICP,FIACM,FGSI,FIAMS,FIMSA, NPO (ART) India 21 st July 2014, Adult Guidelines India

Making of Worlds Second Largest ART Programme Lessons Learnt and challenges ahead 2

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Country with the 2 nd largest number of PLHIV on ART 0.78 million on ART

Outline 1 Process of Guideline revision 2 Major Decisions 3 Challenges in Implementation 4 Road Ahead 5

Adapting the 2013 WHO Guidelines Technical Resource Group (TRG) on Adult ART –Independent technical advisory body –Mandate: reviews guidelines and makes technical recommendations –Programme and financial implementation by NACO 1st meeting (Sept 2013) Understand the 2013 WHO treatment guideline on AIDS and how to implement in local context Exchange the perspectives among policy makers, clinician, civil society, and KAPs on the policy of treatment at any CD4 and discuss on the feasibility to implement 2 nd meeting (Dec 2013) Present data on the programmatic issues raised by experts in the first meeting like availability of FDC, additional number who will be eligible, funding issues, additional HR requirement etc. Consensus

Technical Challenges Programmatic Challenges Implementation challenges

Technical Challenges 8 1.When to start -Earlier threshold -Serodiscordant couples -Hepatitis coinfection 2. What to start -TDF and EFV in preferred 1 st line -Costs 3. How to monitor -Routine Viral load testing -Other monitoring Getting “buy-in” WHO 2013 guidelines are clearly written with details of the evidence around recommendations Extensive preparations before and for the TRG meetings Visit to India by a high level WHO team prior to release of guidelines Knowledge dissemination to programme managers during the WHO regional meetings

Other key facilitators in acceptance Guidelines by the national programme Commitment Evidence Advocacy Public Health Approach Political will Community engagement Technical aspects Together with programmatic aspects TasP Sensitize policy makers Simplified, standardised, harmonized Easily adapted for decentralisation and task sharing Simplified, standardised, harmonized Easily adapted for decentralisation and task sharing

WHO 2013 Recommendations on When to Start in Adults as accepted by NACO Early initiation Option B+ for PMTCT Offer to SDC Early initiation Option B+ for PMTCT Offer to SDC

Updated India guidelines based on WHO 2013 Recommendations Simplify Harmonize Decentralise Access++ Simplify Harmonize Decentralise Access++

Programmatic Issues: Earlier treatment at CD4< 500 Not necessarily will improve coverage –Median CD4 for ART start ~ 200 currently –Estimated about 130,000 people enrolled with the programme with CD –Lead to earlier testing and enrollment? Interaction between ART and co- morbidities in the population –TB, malnutrition, dyslipidemia, renal dysfunction, diabetes, hypertension… Adherence in asymptomatic PLHIV?

Programmatic Issues: Earlier treatment at CD4< 500 Human resources –Increase patient burden at ART clinics –Dependence on GFATM funding: ART centers located within general health services but funded through GF grant so human resource limitation –Dilution of individual counselling Time-lag to operationalise (before the next WHO update in 2015) –budgets, procurement, guidelines dissemination, training…

Programmatic Issues: What to start – TDF/3TC or FTC/EFV Costs –TDF+3TC (single pill) + EFV costs USD 110 pppy vs. TDF+3TC+EFV at USD 150 pppy Limited suppliers –only 2 WHO prequalified companies Renal screening and TDR toxicities –? Co-morbidities in the population –Capacity and costs to health system and decentralised care TDF for children and adolescents Risks vs Benefits

Programmatic issues: How to monitor – viral load testing Quantum of testing and costs: –Targeted VL (10,000 tests p.a) vs Routine VL (800,000 to 1 million tests) –12 million USD needed in Year 1 only for viral load testing Human Resources and capacity: –More labs: currently only 9 labs Sample transport: –DBS still not approved for VL testing Ability for decentralised testing: –At the moment not possible, predict long turnaround times for results –Point-of-care VL testing in the market (?) Investment and health system strengthening

Implementation issues Strategic approaches to improve coverage for earlier HIV testing and delivery of services –Among key populations eg. self-testing, community testing –Nurse-led for ART maintenance Decentralisation & cost-effectiveness of delivery models –How far to primary systems in a low and concentrated diverse epidemic? Strengthening training and quality assurance –Labs, human resource, quality of patient care… Procurement and supplies

Roll-out of the 2013 guidelines Status –TRG recommended all guidelines accepted except for discordant couple –Procurement of drugs planned and in process –Training modules being revised Major policy initiative –Decentralisation to Link ART centres –Supply of drugs for three months –Training- revision of guidelines and curriculum –Virus load testing preparation- package of services in PPP model –Dissemination of guidelines Major service delivery initiative –Decentralization- link centres-FICTC- task shifting –Nurse led model for maintenance being discussed

Challenges ahead Private sector: little data HIV drug resistance and monitoring Early Warning Indicators (EWI) to prevent this Pharmacovigilance for ARV toxicities Convergence/integration with health system without compromising quality Sustaining quality of care Sustaining funding and increasing domestic contribution

Work intensifies after decisions are made 19

Sustaining Prevention & Addressing Emerging Epidemics Vs The growing ART needs Sustaining Prevention & Addressing Emerging Epidemics Vs The growing ART needs 20

NACP-IV Project Financing NACP-III: $ 1.8 Billion NACP-IV: $ 2.7 Billion Note: All figures in Charts in Million USD  Increase in size of overall envelope  Significant increase in government budgetary support & reduction in donor support  Increase in size of overall envelope  Significant increase in government budgetary support & reduction in donor support 21

The Journey ahead Universal access Decentralization Integration Quality issues 22

Thank You