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  EACS - European AIDS Conference
Oct 12-15 2011
Belgrade, Serbia
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Interleukin-6 and C-reactive Protein Levels after 144 Weeks of Efficacy of Darunavir /Ritonavir Monotherapy versus DRV/r + 2NRTIs in the MONET Trial for Patients with HIV RNA < 50 Copies/mL at Baseline: COINFECTED PATIENTS HAD HIGHER IL-6, INFLAMMATION LEVELS (In SMART >3 mg/L was associated with progression), YOU CAN SEE 15% to 19% of PATIENTS HAD VERY HIGH hs-CRP (inflammation) (>3 mg/L), INFLAMMATION WAS MORE LIKELY TO BE HIGHER IF VIRAL LOAD WAS DETECTABLE
  Reported by Jules Levin EACS 2011 Oct 12-15 Belgrade Serbia
J. Arribas1, A. Hill2, Y. van Delft3, C. Moecklinghoff4 1Hospital La Paz, Madrid, Spain, 2MetaVirology Ltd, London, United Kingdom, 3Janssen, Tilburg, Netherlands, 4Janssen, Neuss, Germany


Background: The effects of DRV/r monotherapy on immune activation markers are unknown. Higher Interleukin-6 (IL-6) levels have been associated with faster disease progression in other HIV studies; C-reactive Protein (CRP) is a commonly used marker of inflammation and tissue damage.
Methods: 256 patients with HIV RNA < 50 copies/mL on current HAART for at least 6 months switched to DRV/r 800/100 mg once daily, either as monotherapy (n=127) or with 2NRTI (n=129). Plasma samples from 129 patients were tested retrospectively for IL-6 at Week 144. Plasma samples from 101 patients were tested for CRP at the same time point.
Results: By Week 144, the percentage of patients with HIV RNA < 50 copies/mL (ITT, TLOVR, Switch=Failure) was 69% in the DRV/ r monotherapy arm versus 75% in the triple therapy arm (difference = -5.9%, 95% C.I. -16.9%, +5.1%); by a switch included analysis, HIV RNA < 50 copies/mL was 84.0% versus 83.5% (difference = +0.5%, 95% C.I.: -8.7%, +9.7%). At Week 144, the median (interquartile range) of IL-6 was 238 IU/L (154-465) in the DRV/r arm (n=64) and 263 IU/L (149-460) in the DRV/r + 2NRTI arm (n=65). IL-6 had a strong positive skew in both treatment arms: the range was 55-1969 IU/L in the DRV/r arm and 50-4758 IU/L in the DRV/r + 2NRTI arm. The median (IQ range) CRP level at Week 144 was 2 mg/L (1-4) in the DRV/r arm (n=42) and 2 mg/L (2-3) in the DRV/r + 2NRTI arm (n=59).
Conclusions: In this study, DRV/r monotherapy showed non-inferior efficacy to DRV/r + 2NRTI in the switch included analysis at Week 144, but not in the TLOVR switch equals failure analysis. At Week 144, there was no difference in mean levels of IL-6 or CRP between the treatment arms.