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Long-Term Study Evaluates Boosted PREZISTA(R) Vs. Lopinavir/Ritonavir as Part of HIV Combination Therapy in Treatment-Naive Adults
Date:10/26/2008

- Ninety-six week ARTEMIS data presented at ICAAC -

BRIDGEWATER, N.J., Oct. 26 /PRNewswire/ -- Ninety-six week results presented today from a phase 3, randomized, open-label, ongoing clinical trial showed that 79 percent of treatment-naive HIV-1 infected adults taking PREZISTA(R) 800 mg (two 400 mg tablets) with 100 mg ritonavir (r) once daily reached an undetectable viral load (<50 copies/mL) at week 96, compared with 71 percent of patients taking lopinavir/ritonavir 800 mg/200 mg once daily (or 400 mg/100 mg twice daily), each with a fixed dose of emtricitabine and tenofovir disoproxil fumarate.

Results from the study, known as ARTEMIS, were presented today at the 48th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Washington, DC. ARTEMIS is a 192-week study comparing the efficacy and safety of the protease inhibitors (PIs) PREZISTA/r and lopinavir/r in treatment-naive adults with HIV (those who have never taken HIV medication before). PREZISTA was developed by Tibotec Pharmaceuticals and is marketed in the U.S. by Tibotec Therapeutics, a division of Ortho Biotech Products, L.P.

At 48 weeks, the primary objective of ARTEMIS was reached when PREZISTA/r was demonstrated to be non-inferior to lopinavir/r for virologic response (confirmed HIV RNA < 50 copies/mL). The difference between the treatment arms was not significant at week 48. The pre-planned safety and efficacy analysis at 96 weeks was a secondary endpoint. At 96 weeks, the study showed PREZISTA/r was non-inferior to lopinavir/r for virologic response. The estimated difference in virologic response between the treatment groups was eight percent and was statistically significant (95 percent confidence interval 1.8; 14.7). The 96-week results from ARTEMIS will be submitted to the FDA.

"This study offers the healthcare provider community long-term efficacy and safety data for PREZISTA in treatment-naive adult patients," said Tony Mills, M.D., ART
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SOURCE Tibotec Therapeutics
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