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New Phase 3 Study in Treatment-Naive Adults with HIV Evaluates Efficacy and Safety of Once-Daily PREZISTA(TM)/ritonavir vs. KALETRA(R) as Part of HIV Combination Therapy
Date:9/18/2007

- PREZISTA/ritonavir data presented at ICAAC -

BRIDGEWATER, N.J., Sept. 18 /PRNewswire/ -- Results from a new ongoing, randomized, controlled, open-label Phase 3 study showed that 84 percent of treatment-naive HIV-1 infected adults taking an investigational dose of PREZISTA(TM) (darunavir) 800 mg (two 400 mg tablets) with 100 mg ritonavir once daily with TRUVADA(R)(1) (emtricitabine and tenofovir disoproxil fumarate) reached an undetectable viral load (<50 copies/mL) at week 48, compared with 78 percent of patients taking KALETRA(R)(2) (lopinavir/ritonavir) 800 mg/200 mg once daily (or 400 mg/100 mg twice daily) with TRUVADA. The mean difference in response between the treatment groups was 5.3 percent (95 percent confidence interval -0.5; 11.2).

Results from the study known as ARTEMIS were presented today at the 47th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Chicago. It is the first study to examine PREZISTA/ritonavir (PREZISTA/r) in treatment-naive adult patients with HIV.

ARTEMIS (AntiRetroviral Therapy with TMC114 examined in nave subjects) compared the efficacy and safety of PREZISTA/r with the protease inhibitor (PI) lopinavir/r in treatment-naive adult patients. In a pre-planned analysis, the study met the primary endpoint of non-inferiority (95 percent confidence interval lower limit for the difference in treatment response .12 percent or greater for HIV RNA of less than 50 copies per mL in plasma at week 48).

"This is an important study because it provides information regarding the potential use of a once daily PREZISTA regimen for the treatment of adult patients who have never taken HIV medications before," said Edwin DeJesus, MD, Medical Director of the Orlando Immunology Center and the HUG-Me Program's adult clinic at Orlando Regional Medical Center.

The use of PREZISTA/r in treatment-naive patients and the once-a-day 800 mg dose have not been approved by the FDA. The 48-we
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SOURCE Tibotec Therapeutics
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