Excellent healthcare – locally delivered OVERVIEW OF CLINICAL RECOMMENDATIONS FOR ADULTS, PREGNANT WOMEN AND CHILDREN OVERVIEW OF CLINICAL RECOMMENDATIONS FOR ADULTS, PREGNANT WOMEN AND CHILDREN Dr. Philippa Easterbrook 2013 Consolidated ARV Guidelines Dr. Philippa Easterbrook

30 th June 2013

Guideline Dissemination Regional Guidelines Workshops MonthEventDatesLocation JulyStrategic Use of ARVs23-25/07/2013Yogyakarta, Indonesia JulyAFRO East and Southern Africa 23-25/07/2013Pretoria, South Africa AugustPPTCT Asia Regional PMTCT meeting 27-29/08/2013Kathmandu, Nepal AugustPAHO Regional26-28/08/2013Buenos Aires, Argentina SeptemberEMRO Regional11-13/09/2013Casablanca, Morocco SeptemberWPRO/SEARO Consultation16-18/09/2013Beijing, China OctoberEURO29-31/10/2013Istanbul, Turkey NovemberAFRO East and Central Africa 11-13/11/2013Accra, Ghana DecemberICASA7-11/12/2013Cape Town, South Africa

Objectives of presentation WHO guidelines development and key features Recommendations for Adults, pregnant women and children and Overview of Evidence Base and Rationale: When to Start ART What ART to Start (First-Line) What ART to Switch to (Second-Line) How to Monitor ART

30 th June 2013 Find the New 2013 WHO Consolidated ARV Guidelines on

TOPIC WHEN TO START CD4 ≤200 - Consider CD4 ≤ 350 for TB CD4 ≤ 350 -Irrespective CD4 for TB & HBV PMTCTSince weeks AZT; AZT+ 3TC, or single dose NVP 2004 AZT from 28 weeks + single dose NVP AZT from 28 weeks + single dose NVP +AZT/3TC 7days Option A (AZT +infant NVP) Option B (triple ARVs) 1 ST LINE8 options - AZT preferred 4 options - AZT preferred 8 options - AZT or TDF preferred - d4T dose reduction 6 options & FDCs - AZT or TDF preferred - d4T phase out 2 ND LINEBoosted PI ATV/r, DRV/r, FPV/r LPV/r, SQV/r Boosted PI Heat stable FDC: LPV/r, ATV/r VIRAL LOAD TESTING No (Desirable) Yes Tertiary centers Yes Phase in Evolution of WHO ART Guidelines Vitoria M et al, Curr Opin HIV/AIDS 2013 Earlier initiation Simpler treatment Less toxic, more robust regimens Better monitoring Simplified treatment options for pregnant women

Guidance for Programme Managers HOW TO DO IT? Service delivery Diagnostics Drug supply HOW TO DO IT? Service delivery Diagnostics Drug supply HOW TO DECIDE? Prioritization Equity and ethics Monitoring & Evaluation HOW TO DECIDE? Prioritization Equity and ethics Monitoring & Evaluation WHAT TO DO? When to start or switch Which regimen to use How to monitor Co-infections & co-morbidities WHAT TO DO? When to start or switch Which regimen to use How to monitor Co-infections & co-morbidities Operational WHO 2013 Consolidated ARV Guidelines

Concept Behind Consolidation… Consolidation of new with existing guidance Consolidation across populations and ages Consolidation along the continuum of care

Scoping the document Disclosure and management of secondary interests Formulation of the recommendations (GRADE) Including explicit consideration of:  Benefits and harms  Values and preferences  Resource use Including explicit consideration of:  Benefits and harms  Values and preferences  Resource use Dissemination, implementation (adaptation) Dissemination, implementation (adaptation) Evaluation of impact Plan for updating Formulation of the questions (PICO) and choice of the relevant outcomes Formulation of the questions (PICO) and choice of the relevant outcomes Evidence retrieval, assessment and synthesis (systematic review(s)) Evidence retrieval, assessment and synthesis (systematic review(s)) GRADE - evidence profile(s) WHO Guideline Development PICO: requires specifics of Population, Intervention, Comparator & Outcomes 6 Setting up Guideline Development Group and External Review Group 2

Scoping the document Disclosure and management of secondary interests Formulation of the recommendations (GRADE) Including explicit consideration of:  Benefits and harms  Values and preferences  Resource use Including explicit consideration of:  Benefits and harms  Values and preferences  Resource use Dissemination, implementation (adaptation) Dissemination, implementation (adaptation) Evaluation of impact Plan for updating Setting up Guideline Development Group and External Review Group 2 3 Guideline Development at WHO PICO: requires specifics of Population, Intervention, Comparator & Outcomes 6 Formulation of the questions (PICO) and choice of the relevant outcomes Formulation of the questions (PICO) and choice of the relevant outcomes 4 Evidence retrieval, assessment and synthesis (systematic review(s)) Evidence retrieval, assessment and synthesis (systematic review(s)) GRADE - evidence profile(s) 5

G rades of R ecommendation A ssessment, D evelopment and E valuation

Scoping the document Disclosure and management of secondary interests Dissemination, implementation (adaptation) Dissemination, implementation (adaptation) Evaluation of impact Plan for updating Setting up Guideline Development Group and External Review Group Formulation of the questions (PICO) and choice of the relevant outcomes Formulation of the questions (PICO) and choice of the relevant outcomes Evidence retrieval, assessment and synthesis (systematic review(s)) Evidence retrieval, assessment and synthesis (systematic review(s)) GRADE - evidence profile(s) Guideline development at WHO PICO: requires specifics of Population, Intervention, Comparator & Outcomes Formulation of the recommendations (GRADE) Including explicit consideration of:  Benefits and harms  Values and preferences  Resource use Including explicit consideration of:  Benefits and harms  Values and preferences  Resource use 6

Modelling of impact and cost-effectiveness Earlier ART and different testing strategies Different populations  General population  Serodiscordant couples  Pregnant women  IDUs, sex workers and MSMs  HIV-HBV and HCV Different settings  Generalised (South Africa, Zambia)  Concentrated (Vietnam, India)

Values and Preferences 87 participants Malawi and Uganda Adult (n=98) & Paediatric (n=342): 9 Global implementers (ANEPA, ANECA, CHAI, CDC, EGPAF, ICAP, IeDEA, MSF, PATH) Health care worker consultation Community consultation Option B+ Focus Groups E-survey (n=1088), E-forums (n=955) 6 UN languages E-survey: 21% LIC, 58% MIC; 45% PLHIV; Topics  Earlier ARV initiation  Lifelong ART in pregnant women  Task-shifting and integrated services  Role of communities