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AIDSRelief: Optimizing the Durability of First line Treatment

AIDSRelief: Optimizing the Durability of First line Treatment. Robb Sheneberger, MD Martine Etienne-Mesubi, PhD Mian B. Hossain, PhD Robert R. Redfield, MD University of Maryland School of Medicine Institute of Human Virology July 25, 2012. The AIDSRelief Consortium. AIDSRelief.

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AIDSRelief: Optimizing the Durability of First line Treatment

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  1. AIDSRelief: Optimizing the Durability of First line Treatment Robb Sheneberger, MD Martine Etienne-Mesubi, PhD Mian B. Hossain, PhD Robert R. Redfield, MD University of Maryland School of Medicine Institute of Human Virology July 25, 2012 UMSOM-IHV Division of Clinical Care & Research International Programs

  2. The AIDSRelief Consortium

  3. AIDSRelief Over the eight years of the program • Supported 276 mostly rural treatment facilities in ten countries • Delivered HIV care and treatment to 706,593 clients • Initiated 395,088 patients on ART, including 268,631 currently on treatment at transition quarter

  4. Durability of the Initial Regimen is the Key to Sustainability, Scalability and Long Term ARV Access to Global HIV Treatment Programs

  5. Durability of Initial Regimen: Key Factors • Regimen Choice • Treatment Strategy • Care Delivery System

  6. Durability of the Initial Regimen • Systematic implementation of: • Regimen Choice • Treatment Strategy • Care Delivery Systems • Lack of durability shifts resources from these key areas reducing the ability to progressively improve outcomes • Continued improvement of treatment outcomes to the initial regimen remains a critical area

  7. What we learned about:Regimen Choice • We used national guidelines but moved to greater durability as we were able to work with National governments to transition to more effective NRTIs (i.e. TDF based regimens)

  8. Time to Switch to 2nd line Regimen PLO AIDSRelief: 2008 1.00 0.75 0.50 Probability 0.25 0.00 0 3 6 9 12 15 18 21 24 27 30 33 36 Months D4T/3TC/NVP D4T/3TC/EFV AZT/3TC/NVP AZT/3TC/EFV TRUVADA/NVP TRUVADA/EFV Truvada/NVP or EFV D4T/3TC/EFV N= 5199

  9. What we learned about:Regimen Choice • With increased use of TDF based regimens an in-depth review showed: • On treatment analysis TDF/XTC/EFV had significantly higher odds of viral suppression than AZT/3TC/NVP (p<0.03) or TDF/XTC/NVP (p<0.01) N= 3862 XTC=3TC or FTC Amoroso, A, et al Treatment Outcomes of Recommended First-Line Antiretroviral Regimens in Resource-Limited Clinics JAIDS 1 July 2012 - Volume 60 - Issue 3 - p 314–320

  10. What we learned about:Regimen Choice Missed Appointments and Initial Regimen p<0.004 N=7,513 Fewer people missed appointments on TDF compared to the other regimens

  11. What we learned about:Treatment Strategy • We used national guidelines but moved to greater durability as we were able to work with National governments to treat earlier

  12. What we learned about:Treatment Strategy • Baseline CD4 and viral suppression rates • Higher the initial CD4, greater the chances of increasing durability p<0.001 N=7,513

  13. What we learned about:Treatment Strategy WHO Stage at ART Initiation of Active Patients WHO Stage at ART initiation of Care-ended Patients N=9,747 N=1,762

  14. Mean Baseline CD4 over time, by cohort mean baseline CD4 c/mm3= 229 N=13,135

  15. On Treatment Viral Suppression in Randomly Selected Patients 2006-2011 N=13,770

  16. What we learned about:Care Delivery System We had greater flexibility with the care delivery system and found that patients achieved greater durability in clinical settings that provided comprehensive treatment support, follow up and treatment education

  17. What we learned about:Care Delivery Structure Year 1- initial start up Year 5- follow up n=27 sites; n= 13,391 persons n=143 sites Sites with fewer support systems had greater loss to follow up Etienne, M et. al. Situational analysis of varying models of adherence support and loss to follow up rates; findings from 27 treatment facilities in eight resource limited countries; Trop Med Int Health. 2010 Jun;15 Suppl 1:76-81.

  18. Final Lessons Learned • With consistent and systematic implementation of: • Regimen Choice • TDF favored over D4T or AZT • EFV favored over NVP • Treatment Strategy - starting early = better outcomes • Care Delivery Systems - community based support • Durable viral suppression in the most rural settings is possible

  19. Final Lessons We Are Learning • The care delivery structure is profoundly critical • Overall loss to follow up rates have been increasing as funding as been decreasing • Insufficient investment made to support health care delivery structures to sustain optimal outcomes • The number of deaths, loss to follow up, and dropped out of care may hit critical levels where many of our gains will be lost, and care and treatment will become more complex and costly

  20. Thank you!

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