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New Phase 3 Study Published in The Lancet Evaluates Efficacy and,Safety of Prezista/Ritonavir vs. Kaletra as Part of HIV Combination,Therapy in Treatment-Experienced Adults With HIV

BRIDGEWATER, N.J., July 05, 2007 /PRNewswire/ -- Results from the primary analysis of a randomized, controlled, open-label, Phase 3 study showed that 77 percent of treatment-experienced HIV-1 infected adults taking PREZISTA(TM) (darunavir) 600 mg tablets with 100 mg ritonavir (PREZISTA/r) twice daily, plus an optimized background regimen (OBR) of antiretroviral (ARV) agents, reached a plasma viral load of <400 copies/mL at week 48, compared to 68 percent of patients taking Kaletra(R)1 (lopinavir/ritonavir) 400 mg/100 mg twice daily, plus OBR in a per-protocol analysis. The mean difference in response was nine percent and was statistically significant (95 percent confidence interval 2-16).

The 48-week efficacy and safety results, published in the July 7, 2007 issue of The Lancet, will also be presented at the 4th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2007) in Sydney, Australia on July 24, 2007.

The Phase 3 study, known as TITAN, (TMC114/r In Treatment-experienced pAtients Naive to lopinavir/ritonavir), compared the efficacy and safety of PREZISTA/r with the protease inhibitor (PI) lopinavir/r in treatment- experienced adult patients who were lopinavir/r-naive. The primary endpoint of this study was non-inferiority (95 percent CI lower limit for the difference in treatment response -12 percent or greater) for HIV RNA of less than 400 copies per mL in plasma at week 48 (per-protocol analysis).

"This is exciting new information that adds to the body of knowledge on PREZISTA in a much broader group of treatment-experienced patients," said Daniel Berger, MD, medical director of NorthStar Healthcare and clinical assistant professor of medicine at the University of Illinois, Chicago.

The 48-week primary analysis from the TITAN study provides additional information regarding efficacy and safety of PREZISTA/r in combination with other ARV agen
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