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ODIN: efficacy and safety at 48 weeks of
once-daily versus twice-daily darunavir/ritonavir in treatment-experienced HIV-1-infected patients with no darunavir resistance-associated mutations
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Reported by Jules Levin
CROI SF Feb 16-20 2010
Cahn P, Fourie J, Grinsztejn B, Hodder S, Molina J-M, Ruxrungtham K, Workman C, Van de Casteele T, De Doncker P, Tomaka F on behalf of the ODIN investigators
From Jules: 5 patients entered the study with darunavir specific mutations, it was a protocol violation as they were not supposed to enroll in study, and some of the 5 patients did respond well to once daily darunavir and some did not. The message from this study is that darunavir once-daily is NOT for patients with darunavir specific mutations, twice-daily is recommended. Secondly, 15% of patients entering the study had primary PI mutations but they did respond well, in fact they did as well as patients without primary PI mutations, 78% had undetectable viral load.
ITT = intent-to-treat
TLOVR = lime-to-loss of virologic response
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