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What’s new in the diagnosis, prevention and management of HIV-related cryptococcal d isease

What’s new in the diagnosis, prevention and management of HIV-related cryptococcal d isease. Nelesh Govender (on behalf of the WHO Guidelines Development Group) National Institute for Communicable Diseases, South Africa. Why crypto disease was a priority OI for guidelines development.

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What’s new in the diagnosis, prevention and management of HIV-related cryptococcal d isease

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  1. What’s new in the diagnosis, prevention and management of HIV-related cryptococcal disease Nelesh Govender (on behalf of the WHO Guidelines Development Group) National Institute for Communicable Diseases, South Africa

  2. Why crypto disease was a priority OI for guidelines development • Magnitude of the problem (morbidity and mortality) • Poor access to optimal drugs and diagnostics - opportunities for advocacy • New evidence and opportunities • Lack of guidance for resource-limited settings, or wide variation in recommendations in national guidelines

  3. Objectives of guidelines • To provide evidence-based recommendations on the prevention, diagnosis and management of cryptococcal disease • HIV-infected adults, adolescents and children • Meningeal and non-meningeal disease • Directed at: • Resource-limited settings • Programme managers + National treatment panels • Clinicians providing in and outpatient care • To identify gaps and prioritize areas where further clinical and operational research or advocacy are required.

  4. Guiding principles • Earlier HIV diagnosis and ART initiation - most important preventive strategy to reduce high CM incidence and mortality • Initiate ART CD4 <500 cells, and before < 200. • Prompt HIV testing following diagnosis of CM • Early diagnosis of CM - key to improving mortality • Low threshold for suspecting CM • Prioritise access to rapid diagnostic CrAg assays. • Early initiation of optimal antifungal regimens while minimising drug-related toxicities

  5. 1. Diagnose crypto meningitis earlier • Depending on programmatic considerations and level of facilities: (Strong recommendation, moderate quality of evidence)

  6. 2. Prevent cryptococcal meningitis Routine serum or plasma CrAg screening with pre-emptive fluconazole therapy if CrAg +ve* may be considered in patients with a CD4 ≤ 100 cells and high prevalence of CrAg +ve (>3%) (Conditional recommendation, moderate quality of evidence) *LP and CSF CrAg to exclude active meningitis in patients with symptoms/signs of meningitis

  7. 3. Improve treatment outcomes

  8. 4. Improve treatment outcomes:amphotericin B toxicity Amphotericin B-based regimen is preferred induction option, where available, and when minimum package of pre-emptive hydration + electrolyte replacement + toxicity monitoring and management can be provided. (Strong recommendation, moderate quality of evidence)

  9. 5. Timing of ART initiation • Immediate ART initiation is not recommended in patients with CM due to high risk of IRIS, which may be life-threatening • Defer ART initiation until evidence of a sustained clinical response to anti-fungal therapy AND after: (Boulware D, et al. COAT Trial. N Engl J Med 2014;370:2487-98)

  10. 6. Timing of discontinuation of maintenance treatment Discontinuation* of maintenance treatment if > 1 year stable and adherent to ART and anti-fungal maintenance, and CD4 ≥200 cells (Strong recommendation, low quality of evidence) *Continue maintenance treatment among children aged < 2 years

  11. Non-GRADED PICOT topics • Monitoring treatment response • Diagnostic approach and management of persistent or recurrent symptoms • Raised intracranial pressure • Treatment failure • Cryptococcal IRIS (immune reconstitution inflammatory syndrome)

  12. Next steps • Improving access to crypto diagnostics • CrAg lateral flow assay validation and forecasting demand • Improving antifungal medicines access, supply and registration • WHO Essential Medicines List • Price reduction and generic manufacturing, pooled procurement of amphotericin B and oral 5FC • Harmonization of drug registration • Improved supply and distribution • Improved estimation of disease burden and drug forecasting • Dissemination of guidelines

  13. Acknowledgements Guideline Development Group WHO Philippa Easterbrook Lulu Muhe Marco Vittoria Frank Lule (AFRO) Omar Sued (PAHO) CDC Monika Roy Tom Chiller Joel Chehab 28 peer review group members • Graeme Meintjes, South Africa • NagalingeswaranKumarasamy, India • PloenchanChetchotisakd, Thailand • Tom Harrison, UK • Conrad Muzzora, Uganda • John Perfect, US • Tammy Meyers, South Africa • SayeKhoo, UK • YazdanpanahYazdan, France • George Rutherford, US • Ben Park, US • Neeraj Mohan, India • Papa Salif Sow, Senegal • Nelesh Govender, South Africa • Jon Kaplan, US • Lut Lynen, Belgium • Peter Pappas, US • Ryan Phelps, US

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