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FDA Approves PREZISTA®/ritonavir Once-Daily Dosing for HIV-1 Treatment-Experienced Adults With No Darunavir Resistance-Associated Mutations
Date:12/13/2010

ODIN study were presented earlier this year at CROI 2010, the 17th Conference on Retroviruses and Opportunistic Infections, in San Francisco. The study achieved its primary objective of demonstrating non-inferiority of PREZISTA/ritonavir once daily compared with twice daily.

PREZISTA Indication: AdultsPREZISTA, co-administered with ritonavir and with other antiretroviral agents, is indicated for the treatment of HIV-1 infection.

This indication is based on analyses of plasma HIV-1 RNA levels and CD4+ cell counts from two controlled, Phase 3 trials of 48 weeks duration in antiretroviral treatment-naïve and treatment-experienced patients, and two controlled, Phase 2 trials of 96 weeks duration in clinically advanced, treatment-experienced adult patients. In treatment-experienced adult patients, the following points should be considered when initiating therapy with PREZISTA/ritonavir:


  • Treatment history and, when available, genotypic or phenotypic testing, should guide the use of PREZISTA/ritonavir.

  • The use of other active agents with PREZISTA/ritonavir is associated with a greater likelihood of treatment response.
  • About the ODIN StudyODIN is a Phase 3b, randomized, open-label study that compared the efficacy, safety, and tolerability of PREZISTA/ritonavir 800/100 mg once daily versus PREZISTA/ritonavir 600/100 mg twice daily at week 48 in 590 treatment-experienced HIV-1-infected adult patients with no DRV RAMs (V11I, V32I, L33F, I47V, I50V, I54L/M, T74P, L76V, I84V, L89V). Patients had HIV-1 RNA greater than 1,000 copies/mL and CD4 count greater than 50 cells/mm(3), and received a stable antiretroviral therapy regimen for greater than or equal to 12 weeks at screening. Patients received either once-daily (n=294) or twice-daily (n=296) PREZISTA/ritonavir plus optimized background regimen. The primary objective of the study was to demonstrate non-inferiority of PREZISTA/ritonavir
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    SOURCE Tibotec Therapeutics
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