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INFLAMMATORY MARKERS DURING TREATMENT OF OIs ARE PREDICTIVE OF LATE VIROLOGIC AND IMMUNOLOGIC RESPONSES: Sub-study of A5164
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Reported by Jules Levin
CROI 2010
Sanchez A1, KomarowL2, Andersen J2, AsmuthD4, Grant P3, DevarajS4, Pollard R4, ZolopaA3, and Sattler F1for the AIDS Clinical Trials Group
1. Keck School of Medicine, 2. Harvard School of Public Health, 3. Stanford University, 4. University of California, Davis
BACKGROUND
ACTG study A5164 was a 48-week randomized trial of immediate(I)-ART vsdeferred (D)-ART in 282 participants with acute Opportunistic Infection (OIs) or Bacterial Infections (BIs) but not with tuberculosis.
We hypothesized that I-ART during OI treatment (Rx) would attenuate systemic inflammation more than OI Rx alone by down-regulating HIV nuclear transcription and mediators of inflammation, thereby affecting immunologic and virologic
outcomes later.
We present results of inflammatory cytokines during the first 12 weeks after starting ART and their effects on CD4 counts and viral load (VL) later at weeks 24 and 48.
METHODS
Participants in the I-ART and D-ART arms started ART a median of 12 and 45 days after start of OI-Rx, respectively.
Plasma concentrations of TNFa, sTNFr, IL-6, IL-1, IL-2, IL-17, IL-8, IFN, IL-10, and IL-15 were measured with a Bioplexsystem at study entry, study weeks 4 and 12 of ART for both arms and at ART start for D-ART (D-ART-pre).
Comparisons between randomized arms of cytokine levels and change in cytokines from study entry to week 4 (n=252) and ART week 12 (n=219) use the Wilcoxonrank sum test.
Logistic regression models examined change in Log10cytokine as a predictor of CD4 and VL outcomes.
Favorable outcomes were CD4 >200 cells/mm3and VL <50 at ART week 24 and study week 48.
Deaths prior to week 24 or 48 were considered to be the least favorable outcome.
Type I error was 0.10 in exploratory tables.
In stepwise logistic regression models, p<0.05 was used for other potential predictor variables (age, prednisone at start, hemoglobin grade, LDH (>400), albumin <2.5, and treatment arm).
RESULTS
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