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ICASA IAS

ICASA IAS. Scaling up Treatment Delivery Programmes: Issues, Challenges & Best Practices Siobhan Crowley HIV Department WHO Geneva. % Pregnant women with HIV who received ARVs to reduce MTCT increased 2004-2007 - but 49% still received only single dose nevirapine.

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ICASA IAS

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  1. ICASA IAS Scaling up Treatment Delivery Programmes: Issues, Challenges & Best Practices Siobhan Crowley HIV Department WHO Geneva

  2. % Pregnant women with HIV who received ARVs to reduce MTCT increased 2004-2007 - but 49% still received only single dose nevirapine Percentage of pregnant women with HIV receiving ARVs for PMTCT in low- and middle-income countries Distribution of ARV regimens, 2007 Towards Universal Access – Scaling up priority HIV/AIDS interventions in the health sector. WHO/UNAIDS/UNICEF, June 2008

  3. Progress has been made • More children are receiving ART • Increased from 75,000 in 2005 to almost 200,000 in 2007 • 19 of 20 countries with highest PMTCT burden are in sub-Saharan Africa • 90% of burden is in 20 countries • East,S and SE Asia increase coverage from 18% to 25% in 2008 Towards Universal Access: Scaling up priority HIV/AIDS interventions in the health sector, WHO/UNAIDS/UNICEF 2008

  4. WHO - A Public Health Approach Goal Maximize survival with improved quality of life Principles: • Population-based approach • Evidence-based standards of care • Simplified standardised treatment regimens & patient monitoring • Decentralised and integrated service delivery

  5. Core elements of the a Public Health Approach • Comprehensive approach to HIV prevention, care and ART • Provider-initiated Testing and Counselling • Prevention for those who test negative • Positive prevention for those who test positive • Pre-ART care for those who do not need ART immediately • Continuum of care • Decentralised and integrated service delivery • Treatment literacy, adherence and chronic care • Simplified clinical monitoring & basic laboratory

  6. Harmonised ART Policy Guidance IMAI/IMCI Implementation tools

  7. Audience for WHO guidelines • Primarily national planners and policy makers engaged in public sector ART and in target-setting • Which ARVs to make available in public sector for first and second-line regimens • How to use: the four Ss of clinical management: when to start, substitute, switch and stop • Care implementers - basic knowledge to use ARVs effectively according to national policy recommendations • Trainers, M&E experts – to design appropriate tools and materials to support national policy recommendations

  8. When to start ART

  9. Recommendations for initiating antiretroviral treatment in adults

  10. Issues for -when to start Earlier initiation of adult ART with CD4 350 – 500 • Reduced non AIDS events from cohort data not RCTs, and in industrialised settings • May further reduce HIV transmission • ? Feasibility of CD4 dependent strategy • No's - estimates for disease burden rise > 30% • Associated costs • Health systems demands – increase # providers/sites • Caution with NVP in women + CD4 > 250, men >400

  11. Areas for 2008 review in criteria to start ART adults

  12. When to start in pregnant women Currently WHO recommends • ART in all symptomatic women with CD4 < 350, • Consider ART for all pregnant women with CD4 < 350 • Prophylaxis (AZT + 3TC tail + Sd NVP ) for non ART eligible Being evaluated: • ? combination prophylaxis for all pregnant women <350 or < 500 +/- combination prophylaxis for all women who are breast-feeding • ? Treat all pregnant women irrespective of CD4 • Extended infant prophylaxis if breastfeeding

  13. Key issues ART & pregnancy • ? Safety of stopping post-partum: SMART data • Access to CD4 in ANC • Feasibility in universal ART antenatal / MCH clinic settings • ? What to use – NVP contraindicated CD4 > 250, Efavirenz – teratogenic, concerns re TDF, PIs and metabolic complications not • Complexity and health systems demands • Equity: very different ART access for pregnant • ? Adherence in well women • ? adverse pregnancy outcomes

  14. Children

  15. 6% excess mortality Starting ART when severely immunodeficient increases mortality Arrive E et al. 14th CROI, Los Angeles, CA, 2007 Abs. 727 • 73% median age > 5 years of age, > 50% start with severe immune deficiency, most deaths within 6 months of starting ART • Risk factors for death: • low CD4 • < 18 months age • WHO stage 3/4 • viral load greater than 6·0 log • severe malnutrition Sutcliffe et al. Lancet Infect Dis 2008;8: 477–89

  16. CD4% Increase in Children on cART in SSA Sutdiffe CG et al. Lancet Infect Dis 2008;8:447-89

  17. 1.00 0.80 Deferred Immediate 0.60 0.40 0.20 0.00 0 3 6 9 12 Month 0 Month 3 Month 6 Month 9 Month 12 Deferred 125 104 72 44 22 Immediate 252 213 145 99 52 CHER STUDY : 76% Reduction in the Risk of Death with Immediate Compared to Deferred ART P = 0.0002 Most deaths occurred within first 6 months (i.e., before age 10 months) Failure Probability 16% deferred 4% immediate Time to Death (months) Patients at risk

  18. Revised WHO Guidelines 2008 : When to Start Antiretroviral Therapy in HIV-Infected Children *If Viral test is not possible, use presumptive diagnosis of severe HIV (thrush, severe pneumonia or sepsis) in infants with +ve HIV antibody test and with clinical symptoms of severe HIV – confirm infection status as soon as possible.

  19. What to use

  20. Adults & children (1 year or over) Clinical and/or immunological criteria to start ART Standard first line regimen NNRTI + 2NRTI < 3 years NVP + AZT + 3TC > 3 years EFV + AZT + 3TC Standard second line regimen PI + 2 new NRTI

  21. What ART to Start in infants –2008 revision NVP triple ART No infant or maternal ARV exposure Baby 18% Mum 34% PI triple ART# Sd NVP or NNRTI containing ART MTCT ARV Exposure NVP triple ART No NNRTI exposure Unknown infant maternal MTCT Exposure NVP triple ART # If no PI is available use NVP triple ART

  22. Revised simplified dosing infants & children

  23. WHO FDC ARV tablet regimen superimposed 1 ADULT FDC AM & PM 1 ADULT FDCAM & 0.5 PM 0.5 ADULT FDC AM + PM 2 BABY FDC AM & PM 2 BABY FDC AM & 1 PM 1 BABY FDC AM & 1 PM Most dose adjustments done in 1st year Same dosing irrespective of FDC, or same dosing for all three single ARV agents Adapted from T. NUNN

  24. Percentage of adults and children on 1st and 2nd line regimens (2007)

  25. Median transaction prices for one years treatment Transaction prices for ARVs Summary Report form GPRM Oct 2008

  26. First line failure – when to switch

  27. Clinical Virologic Immunologic Failure / When to Switch Clinical criteria CD4 count Viral load "Late Switch" "Early Switch"

  28. WHO ART Failure Meeting: Major Conclusions Time on ART : Clinical: WHO Stage 3 or 4 after at least 1 year on ART CD4: confirmed CD4 < 100-200 after at least 1 year on ART (check/reinforce adherence before switching decision) HIV RNA threshold : Maintain 10,000 as a switch point (little immediate immune damage). Action when VL> 1,000 (adherence, toxicity, drug interaction assessment) and start to consider switching More efficient use of VL (targeted strategy) Confirm immunologic/clinical failure (?discordance) Pregnant women Adherence monitoring

  29. What to switch to……..second line

  30. # if anaemia use alternative ABC or d4T

  31. Summary of Regimen options - adults

  32. Options for adult second-line ART

  33. Managing co-infection with TB

  34. Geographical distribution of estimated HIV-positive TB cases, 2006

  35. Opportunistic Illnesses

  36. Intensified TB case finding and IPT provision among people living with HIV, 2006 Number of people receiving the intervention as % of estimated PLHIV in reporting Countries 0.96% 12% 0.08% (Number of Countries reporting; % of total estimated HIV+ TB patients accounted for by those Countries)

  37. WHO the 3 'Is' • Intensified case finding • Infection control for TB • Isoniazid preventive therapy

  38. Country HIVDR Committees HIVDR monitoring & surveys The WHO HIVResNet is a global group of experts, laboratories, and organizations constituted to support HIVDR prevention, surveillance, and monitoring as antiretroviral treatment (ART) is rolled out worldwide. Steering Committee WHO Secretariat • WHO HIVResNet • Laboratory Network • Surveillance and Monitoring Network WG Modeling of The emergence and transmission of resistance WG Operational Research Time-Limited Subject Matter Working Groups WG Mutation lists for Surveillance and monitoring WG WG Global Laboratory Network: Criteria, Protocols, Training, QA HIVDR database development and support WG Public Health Assessment Tool For evaluation of country HIVDR data

  39. Transmitted HIV drug resistance Articles reporting results from HIVDR transmission surveys in 7 countries all showed <5% DR in incident cases

  40. Interface between prevention and care PRIMARY PREVENTION Prep and PEP • POSITIVE PREVENTION • Pre ART care – condoms safer sex • Disclosure & partner testing • MTCT prevention • OI & STI prevention Lancet, November 26, 2008 • ART CARE • Reduce Viral load • Likely reduction transmission

  41. HIV ART No ART Current ART Proposed Universal ART

  42. Acknowledgments: Paediatric and adult Guideline groups HIV DR team HIV- dept staff Paediatric ARV dosing working group Charlie Gilks. Marco Vitoria, Lynne Mofenson, Ying-ru Lo, HIV -AMD & GPRM HIV- SIR Yves Soutyrandy Thank you

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