INADEQUACY OF CLINICAL AND IMMUNOLOGIC MONITORING TO IDENTIFY VIROLOGIC FAILURE; THE UGANDA  EXPERIENCE   <ul><li>Basenero...
Background   <ul><li>WHO recommends monitoring antiretroviral therapy (ART) by clinical criteria  and where feasible by im...
Infectious Diseases Institute (IDI) HIV/AIDS care, Research and Training Centre of Excellence Study site
The IDI clinic <ul><li>Free HIV/AIDS care including laboratory testing, opportunistic infections prophylaxis, and ART prov...
ART at the IDI <ul><li>1st line ART  </li></ul><ul><li>d4t, 3TC, NVP ( Multi country Access Program/Global Fund) </li></ul...
ART monitoring at IDI <ul><li>ART is monitored by clinical and immunologic responses  </li></ul><ul><li>CD4+ count measure...
The switch meeting <ul><li>Attended by  doctors, nurses, counselors and pharmacists </li></ul><ul><li>A consensus is reach...
Objectives <ul><li>To evaluate the use of a consensus meeting of care providers in a large urban HIV clinic to determine t...
Methods <ul><li>Suspected ART failing cases are classified </li></ul><ul><li>into 3 categories: </li></ul><ul><li>Clearly ...
Methods <ul><li>Immunological failure defined according to the WHO guidelines </li></ul><ul><li>Adherence measured through...
Category 1 <ul><li>Clearly failing : </li></ul><ul><li>Proven clinical, immunologic and/or virologic failure </li></ul><ul...
Category 2 <ul><li>Patients with poor adherence :  </li></ul><ul><li>Clinical and/or immunologic failure  </li></ul><ul><l...
Category 3 <ul><li>Inconclusive:   </li></ul><ul><li>Immunologic failure BUT clinically stable and with good adherence </l...
Results <ul><li>4200 started ART at IDI since September 2004 </li></ul><ul><li>73% on NVP, 3TC and d4t (MAP) </li></ul><ul...
Results 20 Clinical and Immunologic failure Good adherence 26 Clinical and immunologic failure Poor adherence 54 Immunolog...
Category 1 Clinical and immunologic failure with good adherence (20) All switched to 2nd line 15/15 who had post hock VL >...
Category 2 Poor adherence (26)  Adherence counseling reinforced Monthly for 3 to 6 months 10 (38%)CD4  same or  ↓,  switch...
Category 3 Immunologic Failure But clinically stable (54) 30 (56%)  VL> 400c/ml (median 93,686) (range2611-694,993) 24 (44...
Conclusions   <ul><li>Virological failure can be detected in presence of immunological and clinical failure by a consensus...
Conclusions <ul><li>Immunological failure alone predicted virological failure in only 56% and  may lead to unnecessary ART...
Acknowledgements   <ul><li>Our Friends, the patients at IDI </li></ul><ul><li>Switch meeting team </li></ul><ul><li>IDI st...
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  • The IDI is a state of art institute aimed at provision of HIV Aids care, research and training (Mission statement)
  • Switch meeting is chaired by the director of clinical services at IDI, attended by physicians, infectious dse fellows
  • State in full during the presentation the 3 WHO criteria
  • Adherence measured by patient self report and/ or pill count
  • Ideally the best methods of measuring adherence is drug levels, micro-electro mechanical systems (MEMS) , but this is not practical in clinical setting more so in RLS,
  • Normally picked from the routinely 6/12 CD4 results done on all patients on ART
  • Fixed dose generic combination (triomune)
  • INADEQUACY OF CLINICAL AND IMMUNOLOGIC MONITORING TO IDENTIFY ...

    1. 1. INADEQUACY OF CLINICAL AND IMMUNOLOGIC MONITORING TO IDENTIFY VIROLOGIC FAILURE; THE UGANDA EXPERIENCE <ul><li>Basenero A 1 , Castelnuovo B 1 , Birabwa E 1 , John L 1 , MacAdam K 1 , Schlech W 2 , Kambugu A 1 </li></ul><ul><li>Presenter Dr. Apollo Basenero </li></ul><ul><li>1 Infectious Diseases Institute (IDI), Kampala, Uganda </li></ul><ul><li>2 Dalhousie University Faculty of medicine Canada </li></ul>
    2. 2. Background <ul><li>WHO recommends monitoring antiretroviral therapy (ART) by clinical criteria and where feasible by immunologic monitoring since HIV-RNA measurement is costly </li></ul>
    3. 3. Infectious Diseases Institute (IDI) HIV/AIDS care, Research and Training Centre of Excellence Study site
    4. 4. The IDI clinic <ul><li>Free HIV/AIDS care including laboratory testing, opportunistic infections prophylaxis, and ART provision since September 2004 </li></ul><ul><li>By June 2007 over 18,000 adult patients were registered at IDI </li></ul>
    5. 5. ART at the IDI <ul><li>1st line ART </li></ul><ul><li>d4t, 3TC, NVP ( Multi country Access Program/Global Fund) </li></ul><ul><li>AZT, 3TC and EFV ( Presidential Emergency Plan For AIDS Relief) </li></ul><ul><li>2nd line </li></ul><ul><li>d4T or AZT, ddI, LVP/r </li></ul>
    6. 6. ART monitoring at IDI <ul><li>ART is monitored by clinical and immunologic responses </li></ul><ul><li>CD4+ count measurement every 6 months </li></ul><ul><li>VL not routinely performed (50$) </li></ul><ul><li>The “Switch meeting” is a weekly </li></ul><ul><li>meeting set up in August 2005 to discuss </li></ul><ul><li>patients that are thought to be failing ART </li></ul>
    7. 7. The switch meeting <ul><li>Attended by doctors, nurses, counselors and pharmacists </li></ul><ul><li>A consensus is reached on whether to do a viral load (VL) or employ other interventions </li></ul><ul><li>By IDI policy, change from 1 st line to 2 nd line ART must be approved by this meeting </li></ul>
    8. 8. Objectives <ul><li>To evaluate the use of a consensus meeting of care providers in a large urban HIV clinic to determine the need to switch to 2 nd line treatment in patients suspected to be failing their 1st line regimen </li></ul>
    9. 9. Methods <ul><li>Suspected ART failing cases are classified </li></ul><ul><li>into 3 categories: </li></ul><ul><li>Clearly failing </li></ul><ul><li>2) Patients with poor adherence </li></ul><ul><li>3) Inconclusive </li></ul>
    10. 10. Methods <ul><li>Immunological failure defined according to the WHO guidelines </li></ul><ul><li>Adherence measured through self report (visual analog scale) and pill count </li></ul>
    11. 11. Category 1 <ul><li>Clearly failing : </li></ul><ul><li>Proven clinical, immunologic and/or virologic failure </li></ul><ul><li>Counseling sessions revealed good adherence (>95 %) </li></ul>Switch to 2nd line is recommended, post hoc VL done at switching therapy
    12. 12. Category 2 <ul><li>Patients with poor adherence : </li></ul><ul><li>Clinical and/or immunologic failure </li></ul><ul><li>Counseling reveals missing ART doses on several occasions (<95%). </li></ul>Adherence counseling is emphasized monthly and CD4 count repeated after 3 or 6 months
    13. 13. Category 3 <ul><li>Inconclusive: </li></ul><ul><li>Immunologic failure BUT clinically stable and with good adherence </li></ul>VL is requested
    14. 14. Results <ul><li>4200 started ART at IDI since September 2004 </li></ul><ul><li>73% on NVP, 3TC and d4t (MAP) </li></ul><ul><li>27% on AZT, 3TC and EFV (PEPFAR) </li></ul><ul><li>67% female </li></ul><ul><li>Median age 37.5 yrs </li></ul><ul><li>Median baseline CD4+ count 104 cell/ µL (1-516) </li></ul>
    15. 15. Results 20 Clinical and Immunologic failure Good adherence 26 Clinical and immunologic failure Poor adherence 54 Immunologic failure But clinically stable (N=100) Total number of patients discussed
    16. 16. Category 1 Clinical and immunologic failure with good adherence (20) All switched to 2nd line 15/15 who had post hock VL > 400 c/ml (detectable)
    17. 17. Category 2 Poor adherence (26) Adherence counseling reinforced Monthly for 3 to 6 months 10 (38%)CD4 same or ↓, switched to 2nd line 16 (62%) CD4 increased (36-113)
    18. 18. Category 3 Immunologic Failure But clinically stable (54) 30 (56%) VL> 400c/ml (median 93,686) (range2611-694,993) 24 (44%) VL< 400c/ml
    19. 19. Conclusions <ul><li>Virological failure can be detected in presence of immunological and clinical failure by a consensus of trained clinicians </li></ul><ul><li>In patients with poor adherence, interventions such as intensive counseling are recommended before switching to 2 nd line therapy or performing VL measurement </li></ul>
    20. 20. Conclusions <ul><li>Immunological failure alone predicted virological failure in only 56% and may lead to unnecessary ART change in up to 44% of patients </li></ul><ul><li>This suggests that VL testing should be an essential part of monitoring in RLS and resources should be made available to make this possible. </li></ul>
    21. 21. Acknowledgements <ul><li>Our Friends, the patients at IDI </li></ul><ul><li>Switch meeting team </li></ul><ul><li>IDI staff </li></ul><ul><li>Mulago Hospital and Complex </li></ul>

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