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Five million on ART with improvements in morbidity, mortality and MTCT….

The New WHO Recommendations for HIV Treatment Gottfried Hirnschall World Health Organization Vienna IAS, July 2010. Five million on ART with improvements in morbidity, mortality and MTCT…. Treatment benefits are clear….

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Five million on ART with improvements in morbidity, mortality and MTCT….

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  1. The New WHO Recommendations for HIV TreatmentGottfried HirnschallWorld Health OrganizationVienna IAS, July 2010

  2. Five million on ART with improvements in morbidity, mortality and MTCT….

  3. Treatment benefits are clear…. The number of AIDS-related deaths has declined by over 10% over the past five years… Since 1996 the availability of effective treatment, has saved some 2.9 million lives…

  4. And earlier treatment will also benefit prevention efforts, for both HIV and TB Source: Botswana MOH TB control program report to the Global Fund; mortality Central Statistical Office; ART, MOH; WHO, Botswana Triangulation 2005-6.

  5. New knowledge leads to periodic updating of guidelines… 1996 – Industrialized settings The Dawn of HAART: Combination ART becomes available. “Hit Hard, Hit Early Era” 2010 – WHOguidelines Evidence mounting to treat earlier and with better regimens. Equity key principle “Treat at CD4 <350” 4 ? 1 "Treatment 2.0" Further simplification and optimization of treatment to increase ART access Adding focus on the role of treatment in prevention of new infections 2 2003 – WHO guidelines Treatment costs high, ART toxicity is a concern, health systems are weak “Treat those with greatest need” (Treat at CD4 < 200) "The 3 by 5 Initiative" 2006 – WHO guidelines Access improves, Rx costs lower but late diagnosis as a major barrier Treat if CD4 < 200, but consider if < 350 Commitment to UA 3

  6. Level of evidence taken into account…. • Levels of evidence • Randomized clinical trials • Observational studies • Quality of evidence downgraded or upgraded according to GRADE process • Consideration of equity, risks, benefits, costs, feasibility, acceptability

  7. Major Early ART Studies • Clinical trials: • CHER (children), CIPRA HT001, SAPiT (TB), SMART (sub-study) • Observational data: • AQUITANE, ART-CC, ATHENA, CASCADE, HOPS, NA-ACCORD, PISCIS, TRIVACAN • Ongoing trials (2011-2012): • ACTG 5245, TEMPRANO, START

  8. CIPRA HT001: Early ART increases survival and decreases the incidence of tuberculosis Fitzgerald et al (2009)

  9. When to Start Consortium: analysis of 18 cohorts suggests that earlier start improves outcome When to start consortium.Lancet 2009 Apr 18;373(9672):1352-63

  10. Four guiding principles… • Do no harmWhen introducing changes preserve access for the sickest and most in need • Ensure access and equityAll clinically eligible people should be able to enter treatment (including ART) with fair and equitable distribution of treatment services • Promote quality and efficiencyEnsure delivery of the highest standards of care within a public health approach so as to achieve the greatest health impact with the optimal use of available human and financial resources • Ensure sustainability Understand the long-term consequences of change with the vision of providing continued, life-long access to ART for those in need

  11. 2010 guidelines… Four key messages… 1) Start ART earlier Use ART before becoming sick starting when CD4 threshold is less than 350 cells/mm3 2) Use less toxic and more patient-friendly options Reduce the risk of adverse events and improve adherence by using less toxic drugs as fixed dose combinations 3) Improve management of TB/HIV and HBV/HIV co infectionsStart ART in all PLHIV who have active TB and chronic active hepatitis B disease irrespective of CD4 cell count. 4) Promote strategic use of laboratory monitoring Use laboratory monitoring such as CD4 and viral load to improve efficiency and quality of HIV treatment and care

  12. New ART Recommendations: Benefits • Further reduce death, disability and morbidity • Reduce costs for OI and cancer management • Reduce orphan hood • Improve maternal and child health outcomes • Reduce toxicity • Reduce HIV and TB transmission

  13. Risk of AIDS or Death in patients initiating ART with Different CD4 cell ranges(ART Cohort Collaboration) n=21,247 Sterne et al, 2009

  14. Population-level impact of ART British Columbia, Canada Wood et al. BMJ 2009;338b:1649

  15. ART reduces sexual transmission of HIV: meta-analysis shows no transmission <400 copies/ml Attia S, et al.AIDS 2009 Jul 17;23(11):1397-404.

  16. Some realities…..

  17. ….there are more new infections each year than persons enrolling in treatment… …..the tap is still open…

  18. Late initiation of treatment in Sub-Saharan Africa leads to high initial mortality Source: Egger M, CROI 2007

  19. Counseling and testing is feasible and works in a variety of settings Photos courtesy of Bunnell R, Marum E, and Vestergaard Frandsen

  20. More patients on better regimens will increase cost: drug prices may not fall significantly

  21. Many countries are using these recommendations • In 2010 among 38 countries with available data: • 34 countries adopting CD4 threshold ≤350 cells/mm3 • 29 countries for all patients: Benin, Burkina Faso, Cameroon, CAR, Chad, China , Congo, Côte d'Ivoire, Eritrea, Ghana, Indonesia, Iran, Kenya, Lesotho, Malawi, Mali, Morocco, Moldova, PNG, Saudi Arabia*, Rwanda*, Seychelles*, Senegal, Swaziland, Tanzania, Togo, Ukraine, Zambia, Zimbabwe • 3 countries for pregnant women: Botswana (other patients CD4 ≤ 250 cells/mm3), South Africa (other patients CD4 ≤ 250 cells/mm3), DRC • 2 countries are planning the adoption in 2011 : Burundi, Djibouti • 4 countries are in process of decision (by end 2010): • Ethiopia, India, Mozambique, Uganda Source: WHO survey 2010 on ARV use, June 1st, 2010

  22. New guidelines… what are implications ? • Numbers eligible (in need) increase: ART coverage will decrease • Treatment cost - will initially increase (but long term benefits may balance out…)….. Costing work in progress • Non-drug related costs: need for efficiency gains (e.g. task shifting, and community engagement) • Laboratories: need for wider access to CD4 and VL, Hep B tests • HIV testing: need for a proactive people centred approach within a human rights framework • Human resources: increased demand at all levels (MCH, TB, harm reduction services, etc.) • Potential to exacerbate waiting lists - prioritization ?

  23. Next steps… • Country guideline review process • Move progressively towards adopting all recommendations and address operational questions • prioritize resources to facilitate full implementation over time • Not compromise ART access or exclude those most in need

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