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2013 Consolidated ARV Guidelines. OVERVIEW OF CLINICAL RECOMMENDATIONS FOR ADULTS, PREGNANT WOMEN AND CHILDREN Dr. Philippa Easterbrook. Dr. Philippa Easterbrook. Guideline Dissemination Regional Guidelines Workshops. Objectives of presentation. WHO guidelines development and key features
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2013 Consolidated ARV Guidelines OVERVIEW OF CLINICAL RECOMMENDATIONS FOR ADULTS, PREGNANT WOMEN AND CHILDRENDr. Philippa Easterbrook Dr. Philippa Easterbrook
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
Find the New 2013 WHO Consolidated ARV Guidelines on http://www.who.int/hiv/pub/guidelines/arv2013/en/index.html
Evolution of WHO ART Guidelines Vitoria M et al, CurrOpin HIV/AIDS 2013 Earlier initiation Simplified treatment options for pregnant women Simpler treatment Less toxic, more robust regimens Better monitoring
WHO 2013 Consolidated ARV Guidelines WHAT TO DO? • When to start or switch • Which regimen to use • How to monitor • Co-infections & • co-morbidities Operational Clinical Guidance for Programme Managers HOW TO DO IT? • Service delivery • Diagnostics • Drug supply HOW TO DECIDE? • Prioritization • Equity and ethics • Monitoring & Evaluation
Concept Behind Consolidation… • Consolidation across populations and ages • Consolidation along the continuum of care • Consolidation of new with existing guidance
WHO Guideline Development 1 2 3 4 6 7 9 Scoping the document Setting up Guideline Development Group and External Review Group Disclosure and management of secondary interests Formulation of the questions (PICO) and choice of the relevant outcomes 5 Evidence retrieval, assessment and synthesis (systematic review(s)) PICO: requires specifics of Population , Intervention, Comparator & Outcomes GRADE - evidence profile(s) Formulation of the recommendations (GRADE) • Including explicit consideration of: • Benefits and harms • Values and preferences • Resource use Dissemination, implementation (adaptation) 8 Evaluation of impact Plan for updating
Guideline Developmentat WHO 1 2 3 4 6 7 9 Scoping the document Setting up Guideline Development Group and External Review Group Disclosure and management of secondary interests Formulation of the questions (PICO) and choice of the relevant outcomes 5 Evidence retrieval, assessment and synthesis (systematic review(s)) PICO: requires specifics of Population , Intervention, Comparator & Outcomes GRADE - evidence profile(s) Formulation of the recommendations (GRADE) • Including explicit consideration of: • Benefits and harms • Values and preferences • Resource use Dissemination, implementation (adaptation) 8 Evaluation of impact Plan for updating
Grades of Recommendation Assessment, Development and Evaluation
Guideline developmentat WHO 1 2 3 4 6 7 9 Scoping the document Setting up Guideline Development Group and External Review Group Disclosure and management of secondary interests Formulation of the questions (PICO) and choice of the relevant outcomes 5 Evidence retrieval, assessment and synthesis (systematic review(s)) PICO: requires specifics of Population , Intervention, Comparator & Outcomes GRADE - evidence profile(s) Formulation of the recommendations (GRADE) • Including explicit consideration of: • Benefits and harms • Values and preferences • Resource use Dissemination, implementation (adaptation) 8 Evaluation of impact Plan for updating
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 Community consultation • Option B+ Focus Groups • 87 participants • Malawi and Uganda • 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 Health care worker consultation • Adult (n=98) & Paediatric (n=342): • 9 Global implementers (ANEPA, ANECA, CHAI, CDC, EGPAF, ICAP, IeDEA, MSF, PATH)