Subgroup analysis and predictors of virologic response in treatment-experienced HIV-1-infected patients in the ODIN trial
P. Cahn1, S. Hodder2, P. Mootsikapun3, J. Suleiman4, T. Van de Casteele5, P. De Doncker5, E. Lathouwers5, F. Tomaka6
1Fundación Huesped, Buenos Aires, Argentina, 2University of Medicine and Dentistry of New Jersey, Newark, United States, 3Infectious Disease Unit, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand, 4Brasilmed Assistencia Medica e Pesquisas, Sao Paulo, Brazil, 5Tibotec BVBA, Mechelen, Belgium, 6Tibotec Inc., Titusville, United States
Background: ODIN was a Phase III, randomised, open-label study that demonstrated non-inferiority of darunavir/ritonavir (DRV/r) 800/100mg qd vs DRV/r 600/100mg bid in treatment-experienced HIV-1-infected adults with no DRV RAMs at screening. Week-48 analysis of virological response by subgroups is reported.
Methods: Virological response (HIV-1 RNA < 50 copies/mL; intent-to-treat, time-to-loss of virological response) was assessed by baseline stratification factor (HIV-1 RNA ≤ or >50,000 copies/mL), baseline CD4 count, number of previously used PIs, number of active NRTIs in the optimised background regimen (OBR), presence of primary PI mutations and PI RAMs or M184I/V mutation at baseline, and adherence (based on patient questionnaire). A multivariate logistic regression analysis was conducted to investigate factors predictive of virological response.
Results: Differences in virologic responses between DRV/r qd and bid arms were consistent across subgroups (Table).
In the multivariate model baseline CD4 cell count, number of prior PIs, number of active NRTIs in the OBR, the presence of primary PI mutations and PI RAMs were not significantly associated with response. Baseline HIV-1 RNA (P=0.0014), M184V/I presence at baseline (P< 0.0001) and adherence (P< 0.0001) were significantly associated with response.
Conclusions: Week 48 virological responses were comparable between DRV/r qd and bid for all subgroups. Baseline HIV-1 RNA, presence of M184V/I and adherence were independently associated with virological response, but other factors examined (including study arm and prior PI mutations) were not.
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