Pharmacokinetic (PK) and pharmacodynamic analyses of once- and twice-daily darunavir/ritonavir (DRV/r) in the ODIN trial
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چکیده
Background In the Phase III, randomised, open-label ODIN trial, treatment-experienced HIV-1-infected adults with no screening DRV resistance-associated mutations received DRV/r 800/100mg qd or DRV/r 600/100mg bid (both arms + ≥2 NRTIs). At Week 48, 72.1% qd vs 70.9% bid patients achieved HIV-1 RNA <50 copies/mL (95% CI = -6.1 to 8.5%, p<0.001; ITT-TLOVR), confirming noninferiority of DRV/r qd. The relationship between DRV PK and efficacy and safety following treatment with DRV/r is explored.
منابع مشابه
Health-related quality of life (HRQoL) assessment with once- and twice-daily darunavir/ritonavir (DRV/r) in the ODIN trial
Background The open-label, Phase III, ODIN trial randomised treatment-experienced HIV-1-infected patients with no DRV resistance-associated mutations (RAMs) to receive DRV/ r 800/100mg qd or DRV/r 600/100mg bid, plus an optimised background regimen (≥2 NRTIs). Non-inferiority in the primary endpoint of virological response at Week 48 was demonstrated with DRV/r qd versus bid dosing: 72.1% vs 70...
متن کاملVirological analysis of once-daily and twice-daily darunavir/ritonavir in the ODIN trial of treatment-experienced patients.
BACKGROUND The aim of this analysis was to characterize viral resistance in the Phase III, randomized ODIN trial, which demonstrated non-inferiority of once-daily darunavir/ritonavir (DRV/r) 800/100 mg to DRV/r 600/100 mg twice daily, each combined with an optimized background regimen in treatment-experienced patients with no DRV resistance-associated mutations (RAMs) at screening. METHODS Vi...
متن کاملWeek 48 analysis of once-daily vs. twice-daily darunavir/ritonavir in treatment-experienced HIV-1-infected patients.
OBJECTIVE ODIN (Once-daily Darunavir In treatment-experieNced patients) was a phase III, 48-week, open-label study comparing once-daily vs. twice-daily darunavir/ritonavir (DRV/r) in treatment-experienced patients with no DRV resistance-associated mutations (RAMs) at screening. METHODS Patients with no DRV RAMs and receiving stable HAART for at least 12 weeks were stratified by HIV-1 RNA (≤ o...
متن کاملEfficacy of Once Daily Darunavir/Ritonavir in PI-Naïve, NNRTI-Experienced Patients in the ODIN Trial.
Background. An exploratory subanalysis of the ODIN trial was performed to evaluate the efficacy of darunavir/ritonavir (DRV/r) 800/100 mg OD versus 600/100 mg BID in patients who were NNRTI-experienced but PI-naïve. Methods. ODIN was a phase III, 48-week study comparing DRV/r OD versus BID in 590 treatment-experienced patients with no DRV resistance-associated mutations (RAMs) at screening. Pat...
متن کاملSimplification from twice-daily to once-daily darunavir/ritonavir in a randomized trial among HIV-infected persons with HIV-1 RNA suppression on antiretroviral therapy.
BACKGROUND DRIVESHAFT is a randomized, open-label, 48-week clinical trial that examined virological outcomes and safety of antiretroviral simplification among virologically suppressed, treatment-experienced HIV-infected patients switching from darunavir/ritonavir (DRV/r) twice-daily-based regimens to a once-daily DRV/r component. METHODS HIV-infected adults with a stable antiretroviral regime...
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