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What are US, European and National Guidelines from Resource Limited Settings (RLS) Recommending ?

What are US, European and National Guidelines from Resource Limited Settings (RLS) Recommending ?. G. Gavriilidis, PJ. Easterbrook, L. Muhe, M. Vitoria World Health Organization, HIV Department (ATC) Geneva, Switzerland July 2011. Current Recommendations. Areas of consensus and discrepancy.

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What are US, European and National Guidelines from Resource Limited Settings (RLS) Recommending ?

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  1. What are US, European and National Guidelines from Resource Limited Settings (RLS) Recommending? G. Gavriilidis, PJ. Easterbrook, L. Muhe, M. Vitoria World Health Organization, HIV Department (ATC) Geneva, Switzerland July 2011

  2. Current Recommendations

  3. Areas of consensus and discrepancy Consensus: • Amphotericin B + 5FC as first line in high income countries and AmB + Fluconazole in RLS (IDSA and MSF) • Lack of specific monitoring and toxicity management guidance Discrepancy: • Dose of Amphotericin B (0.5-1, 0.7-1,1 mg/kg) • Fluconazole induction dose (400mg, 400-800mg, 800mg, 800-1200 mg, 1.2-2g) and consolidation dose (400mg, 800mg), and duration. • Criteria for discontinuation of secondary prophylaxis (Lifelong, Immune reconstitution on ART, CD4cell count and HIV RNA criteria) • Role of Itraconazole (alternative induction, consolidation or maintenance)

  4. Survey of National OI Guidelines in RLS (n=33) • Sources: • In-house databases • Key websites • WHO regional and country offices • Other key informants

  5. Africa: Botswana, Côte d'Ivoire, Kenya, Madagascar, Namibia, Rwanda, Senegal, Zambia, Americas: Argentina, Dom Republic, Ecuador, Guatemala, Panama, Paraguay, Venezuela, Asia: Bhutan (16) (12) Africa: Comoros, Ethiopia, Lesotho, Liberia, Tanzania Americas: Guyana Asia: China, India, Lao PDR, Malaysia, Myanmar, Vietnam (2) Cuba, El Salvador (2) Mozambique, Haiti Nigeria (1) 1st Line Induction (n=33) • Recommended AmB dose varied (0.4, 0.6-1, 0.7, 0.7-1, 1 mg/kg/day) • Two countries recommended either lower than the standard dose of AmB (Mozambique and Malaysia, 0.4mg/kg) or not per kg based dosing (China, 30-40mg QD)

  6. All Alternative Regimens (n=33) Number of Alternatives Provided 0: n=7 1: n=18 2: n=6 5: n=1 IV duration: 3d-10w (median=2w) (1) (3) (8) (4) PO duration: 2-12w (median=8w) (4) (15) (1)

  7. Minimum Induction Fluconazole dose (n=15) Mozambique, Cuba, Ecuador (3) Africa: Botswana, Côte d'Ivoire, Ethiopia, Kenya, Lesotho, Senegal, Tanzania Americas: Argentina, El Salvador, Haiti Duration: 3d (n=1); 4w (n=1); 6w (n=1) (10) Duration: 2w (n=2); 4-6w (n=2); 8-10w (n=3); 12w (n=2); lifelong (n=1) Guatemala, Paraguay (2) Duration: 8-10w (n=1); lifelong (n=1)

  8. Consolidation Fluconazole dose (n=26) 200mg (1) Senegal Africa: Botswana, Comoros, Ethiopia,, Kenya, Lesotho, Liberia, Madagascar, Mozambique, Namibia, Rwanda, Tanzania Americas: Argentina, Ecuador Guatemala, Guyana, Paraguay, Venezuela Asia: Bhutan, India, Myanmar, Vietnam 400mg (1) Cuba (22) (2) Côte d'Ivoire, Malaysia

  9. Treatment Monitoring Recommendations (n=33) Africa: Madagascar, Namibia, Nigeria, Rwanda, Senegal Americas: Panama, Paraguay, Venezuela (8) (23) (2) Botswana, Kenya Complete: Guidelines that cover neurological, renal, liver, blood and electrolyte monitoring and frequency for CM Partial/Unspecific: Guidelines that omit one or more of the above, or give general instructions for patient follow-up (not specific to CM treatment)

  10. Focus of Monitoring (n=33) (6) (11) (12) (7) (10) (7)

  11. Secondary prophylaxis (n=29) Duration • 77%: did not specify • 15%: indefinite • 8%: until CD4 >100-200 cells/mm3 on ART (29) 200mg (n=29) Africa: Côte d'Ivoire, Rwanda Americas: Dom. Republic, Panama, Paraguay, Venezuela Asia: China (7) 0.5mg QW (n=2); 0.6mg QW (n=2) 1mg QW (n=3) Argentina, Panama, Ecuador, Venezuela (4) 200mg (n=2); 400mg (n=2)

  12. Conclusions • Still wide variation in drug, dose and duration of initial and alternative treatment regimens • Specific areas of concern e.g.: • Too low a dose (or too short a duration) of oral fluconazole regimens for induction and consolidation • Use of amphotericin B as maintenance • Few national guidelines include explicit, complete and detailed instructions for monitoring and management of toxicities • Minimal paediatric guidance

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