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History of Opportunistic Complications: Should This Remain An Exclusionary Criterion?

History of Opportunistic Complications: Should This Remain An Exclusionary Criterion?. Kathleen E. Squires, M.D. Associate Professor of Medicine Keck School of Medicine University of Southern California. Opportunistic Complications: Current Situation.

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History of Opportunistic Complications: Should This Remain An Exclusionary Criterion?

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  1. History of Opportunistic Complications: Should This Remain An Exclusionary Criterion? Kathleen E. Squires, M.D. Associate Professor of Medicine Keck School of Medicine University of Southern California

  2. Opportunistic Complications:Current Situation • History of opportunistic complications (infections or neoplasia) is an absolute reason for exclusion • Reason: immunosuppression required for transplantation will put these patients at increased risk of experiencing recurrence or a new complication • Studies do indicate that history of one OI confers increased risk of developing a novel OI

  3. Opportunistic Complications:Proposal to Change Eligibility Criteria • Reevaluate this requirement after the first 20 transplants: • if total number if OC’s in this group is </= 1, criteria would be changed to allow subjects with history of an OC to enroll • OC occurred some defined period of time prior to enrollment • Is there data to support this proposal?

  4. Changing Spectrum of Opportunistic Complications in the HAART Era • There has been a marked decline in the incidence of nearly all AIDS-defining opportunistic complications in the US and Europe • This decline has been linked temporally to advent of potent triple drug antiretroviral therapy • Several OC’s for which there is no definitive therapy (e.g. cryptosporidiosis, PML) have responded to HAART alone • Atypical presentations of well-characterized OC’s (vitritis, CMV; fever, regional adenopathy; MAC)

  5. Changing Spectrum of Opportunistic Complications in HAART ERA • Many lines of evidence indicate that immune reconstitution does occur: • evidence of increase in thymic mass in patients receiving HAART • gradual rise in naïve T cell populations • documentation of organism-specific host defense mechanisms • UPHS Guidelines now recommend discontinuation of primary and secondary prophylaxis for essentially all OI’s

  6. Changing Spectrum of Opportunistic Complications in HAART Era • Clinicians are now considering stopping ART in patients who have evidence of • sustained suppression of viral replication • CD4 counts >350 cells/mm3 for 1.5-2 years • SMART trial • There are concerns with this approach: • Incidence of lymphoma • Chronic viral infections (HPV)

  7. Opportunistic Complications in the Setting of Transplantation:What Should We Do? • The data supports allowing individuals with history of OI to undergo transplantation • Possible eligibility criteria: • viral load <400 (50) copies/mL for 6-12 months • CD4 cell counts >/=350 cells/mm3 for how long? • Maintain ART • Maintain or consider restarting prophylaxis • Monitor chronic conditions

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