Predictors of ART-associated TB in a prospective study: Results of the Kericho IRIS Study The Rainbow of IRIS in HIV Infection July 26, 2012 Fredrick.

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Predictors of ART-associated TB in a prospective study: Results of the Kericho IRIS Study The Rainbow of IRIS in HIV Infection July 26, 2012 Fredrick Kirui, MBChB, MMED Kenya Medical Research Institute/Walter Reed Project HIV Program Kericho, Kenya

IRIS-Kericho A Cohort Observational Study Evaluating Predictors, Incidence and Immunopathogenesis of Immune Reconstitution Syndrome (IRIS) in HIV-1 Infected Patients with CD4 Count <100 Cells/µL who are Initiating Antiretroviral Therapy Primary Objectives:  To identify baseline predictors of IRIS within 6 months of ART initiation.  To evaluate the immunopathogenesis of IRIS with the goal to identify more appropriate therapeutic targets and interventions. 200 volunteers enrolled between February 2009 and June 2010 and followed for 2 years

Participant Characteristics at Baseline CharacteristicValue [mean (SD) or %] Age (yrs)36.5 (8.2) Female53 BMI (kg/m 2 ) 18.6 (3.6) HgB (g/dL)11.2 (2.1) Cr (mmol/L)66.6 (21.0) ALT (U/L)34.3 (31.5) CD4 (T cells/mm 3 )43.2 (35.8) HIV-1 RNA (copies/ml)347,327 (266,135)

TB in the IRIS Study IRIS Events (37)  Majority of IRIS cases observed were TB related (17, 46%)  Approximately 2/3 were unmasking TB ART associated TB (within 6 months of ART initiation - considered unmasking TB-IRIS per ACTG definition)  31 cases (19%) of participants  Mean age=37 years, 59% F  At an average of 6 weeks after ART initiation  PTB (63%) > extra-pulmonary (25%) > disseminated (12%)

Comparison of ART-associated TB cases with non-TB study participants Compared to controls TB cases at baseline had: - Lower Hgb (9.4 vs gm/dL, p=<0.0001) and BMI (17.7 vs. 18.9, p=0.015) - Higher ESR (74.6 vs mm/hr, p=0.002) - Higher proportion of CD8+/PD1+ T cells (39.9 vs. 29.%, p=0.007) *remained significant in regression analysis (p=0.005) - Higher mortality (28% vs 9% p=0.0066) Screening of patients with low CD4 counts and BMI and anemia and high ESR may facilitate earlier TB diagnosis and treatment.

Asanteni Sana! IDCRPNIAIDUSMHRPKEMRI/WRP Brian AganIrini SeretiNelson MichaelFred Sawe Greg MartinAlice PauDeline GloverKibet Shikuku Gregg RobyJun TanDeborah Langat JoAnn MicanHellen Ngeno Virginia Sheikh Argwings Miruka Lazarus Momanyi Doug Shaffer IRIS Endpoint Committee: Martyn French, Chair IDCRPNIAIDUSMHRPKEMRI/WRP Brian AganIrini SeretiNelson MichaelFred Sawe Greg MartinAlice PauDeline GloverKibet Shikuku Gregg RobyJun TanDeborah Langat JoAnn MicanHellen Ngeno Virginia Sheikh Argwings Miruka Lazarus Momanyi Doug Shaffer IRIS Endpoint Committee: Martyn French, Chair IRIS Study Volunteers