2. Transplantation in HIV Michelle Roland, MD Assistant Professor of Medicine UCSF Positive Health Program at SFGH

3. Background HIV-infected patients have been excluded from consideration for transplantation because: 1. Morbidity too high to justify organ use 2. Immunosuppression might accelerate HIV disease Mortality is reduced with HAART Prospective study will evaluate: 1. Effect of immunosuppression on survival and HIV disease 2.Effect of HIV on graft survival 3. Drug interactions between PI/NNRTI and immunosuppressives Many centers transplanted patients prior to the study

4. Methods Prospective analysis of enrolled subjects + Retrospective review of recipients at study centers “Eligible” subjects: No opportunistic infection history CD4 > 200 kidney; >100 liver HIV RNA < 50 kidney, liver or unable to tolerate ARVs in liver but post-transplant suppression predicted “Ineligible” subjects: Did not meet 1 or more criteria above

5. Results: Baseline 41 “Eligible” Subjects 22 Kidney and 19 Liver 8 “Ineligible” Subjects undiagnosed HIV, HIV RNA > 50 (K), low CD4, altered MS, history of OI/ON Baseline CD4+ T Cell Counts Kidney: 455 (200 - 1054) Liver:321 (103 - 973) Baseline HIV-1 RNA Liver: <50 (<50 - 115,776)

6. Results: Outcomes Median follow-up279 days (3 - 1567) Deaths1 kidney + 3 liver - recurrent hepatitis C - rejection after PI stopped - post-op complications x 2 Opportunistic Complications 1 liver + 1 kidney - CMV esophagitis - candida esophagitis

7. Results: Outcomes CD4+ T Cell Counts Kidney 460 (76 - 1300) Liver296 (89 - 590) HIV-1 RNA Kidney< 50 (< 50 - 11,343) Liver <50 (<50 - 80) Re-transplantation1 liver Graft loss1 kidney Additional rejection36% kidney + 11% liver

8. Outcomes: Ineligible Subjects Undiagnosed HIVdeath (MAC< PML) Altered MSdeath (PML) HIV RNA > 50 (K)all <50 or < 400 Low CD4stable 76 --> 102 History of OI/ON (PCP + CMV; KS + CMV)no recurrence at 15 months and 5 weeks

9. Conclusions Patient survival is comparable to UNOS data at 1 year 95% kidney subjectsUNOS = 94.8% cadaver/97.6% living 84% liver subjectsUNOS = 87.9% No significant HIV disease progression in selected pts 2 OI s could be due to HIV or immunosuppression Stable CD4+ T-cell counts and suppressed HIV-1 RNA There is HIV progression with advanced disease Graft survival is comparable to UNOS data at 1 year 89% kidney subjectsUNOS = 89.4% cadaver/94.5% living 84% liver subjectsUNOS = 81.4%