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Delphine Sculier, MD,MPH Stop TB Department World Health Organisation Geneva, Switzerland

Update on the revision of ART guidelines for TB patients. Delphine Sculier, MD,MPH Stop TB Department World Health Organisation Geneva, Switzerland. Outline of presentation. Critical ART issues that were reviewed Process of drafting recommendations Main changes from 2006 to 2010

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Delphine Sculier, MD,MPH Stop TB Department World Health Organisation Geneva, Switzerland

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  1. Update on the revision of ART guidelines for TB patients Delphine Sculier, MD,MPH Stop TB Department World Health Organisation Geneva, Switzerland

  2. Outline of presentation • Critical ART issues that were reviewed • Process of drafting recommendations • Main changes from 2006 to 2010 • Recommendations for HIV-infected TB patients • Conclusions

  3. WHO ART treatment guidelines –the critical issues being reviewed How to diagnose earlier? • Critical patient & public health important outcomes: • Mortality • Disease progression (morbidity) • Severe or regimen limiting adverse events • Adherence & retention on ART • Durability of regimen effect • Reduction of HIV transmission • Cost How to monitor? When to Start? What to Use 1st Line? What to use- 2nd Line? Third line ?

  4. Drafting Recommendations and Risk Benefit Analysis • Systematic reviews and GRADE profiles • Impact assessment reports • PLWH consultation reports • Costing and feasibility analysis DRAFT RECOMMENDATIONS VALIDATION BY REVIEW GROUPS FINAL RECOMMENDATIONS

  5. ART guidelinesChanges from 2006 to 2010

  6. Laboratory monitoring WHO 2006 Proposed WHO 2010

  7. Recommendations for HIV infected TB patients When to start? What to start?

  8. Grade review: When to start ART in HIV-infected TB patients? SAPiT: Optimal Time to Initiate ART in HIV/TB-Coinfected Patients Early ART ART initiated during intensive or continuation phase of TB therapy (n = 429) HIV-infected patients diagnosed with TB and CD4+ cell count < 500 cells/mm3 (N = 642) Sequential ART ART initiated after TB therapy completed (n = 213) Primary endpoint: all-cause mortality From Larry William Chang, MD, MPH, Johns Hopkins School of Medicine, Cochrane Collaborative Group on HIV/AIDS at UCSF

  9. SAPiT: Increased survival with concurrent HIV and TB treatment 1.00 Early ART Sequential ART 0.95 0.90 Survival 0.85 0.80 Intensive phase of TB treatment Post-TB treatment Continuationphase of TB treatment 0.75 0.70 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 Months Post-randomization Abdool Karim SS, et al. CROI 2009. Abstract 36a.

  10. GRADE Table From Larry William Chang, MD, MPH, Johns Hopkins School of Medicine, Cochrane Collaborative Group on HIV/AIDS at UCSF

  11. Randomised controlled trials N2R (Manosuthi 2009) (Thailand, N=142) Observational studies Boulle 2008 (South Africa, N=1 283) Manosuthi 2008 (Thailand, N=188) Sathia 2008 (UK, N=103) Shipton 2009 (Botswana, N=155) Sungkanuparph 2006 (Thailand, N=29) Varma 2009 (Thailand, N=667) Grade review: What to start in HIV-infected TB patients? EFV vs. NVP in patients taking rifampicin From George W. Rutherford, M.D. University of California, San Francisco Global Health Sciences

  12. EFV vs. NVP in TB patients Manosuthi 2009 (N2R) MH Mantel-Haenszel, RE random effects RR <1.0 favours EFV From George W. Rutherford, M.D. University of California, San Francisco Global Health Sciences

  13. EFV vs. NVP in TB patients Observational studies From George W. Rutherford, M.D. University of California, San Francisco Global Health Sciences

  14. WHO 2009 Proposed Recommendations on When to Start & What to Use in TB/HIV

  15. WHO 2009 Proposed Recommendations on When to Start & What to Use in TB/HIV (ctd)

  16. Risk Benefit Analysis

  17. Risk Benefit Analysis (ctd)

  18. Conclusions • Trends: • Encourage earlier diagnosis • Treat earlier • Promote less toxic/ more friendly regimens • Monitor more strategically • Will cost more • The major operational question is not if these recommendations should be followed or not, but how to do it safely and with equity • For TB/HIV, the panel placed high value on the reduction of the current high level of mortality from HIV/TB co-infection and the positive impact on TB transmission and prevalence of initiating ART in all HIV infected individuals with TB in developing these recommendations.

  19. Acknowledgments • Haileyesus Getahun, Stop TB Dept • Marco Vitoria, HIV/AIDS Dept

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