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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

EZISTA/r arm reached an undetectable viral

load (<50 copies/mL) vs. 75 percent of patients in the lopinavir/r

arm, (p=not significant).

-- Of patients with baseline CD4+ cell count less than 200 cells per cubic

millimeter, 79 percent of patients in the PREZISTA/r arm reached an

undetectable viral load (<50 copies/mL) vs. 65 percent of patients in

the lopinavir/r arm, (p=0.009).

-- Of patients with baseline CD4+ cell count greater than 200 cells per

cubic millimeter, 79 percent of patients in the PREZISTA/r arm reached

an undetectable viral load (<50 copies/mL) vs. 75 percent of patients

in the lopinavir/r arm, (p=not significant).

ARTEMIS Safety Findings

-- Incidence of grade 2-4 treatment-related diarrhea reported in the

PREZISTA/r arm was four percent vs. 11 percent in the lopinavir/r arm.

Nausea was reported in two percent vs. three percent, respectively.

-- In both treatment arms, grade 2-4 treatment-related rash occurred

infrequently; three percent in the PREZISTA/r arm vs. one percent in the

lopinavir/r arm.

-- Discontinuations due to adverse events were four percent in the

PREZISTA/r arm vs. nine percent in the lopinavir/r arm.

Dosing

Recommended dosing for treatment-naive adult patients is 800 mg (two 400 mg tablets) taken with 100 mg ritonavir once daily with food. The new 400 mg tablet will be available by November 1. For treatment-experienced adult patients, the dosing for PREZISTA remains 600 mg taken with 100 mg ritonavir twice daily with food. PREZISTA must be taken in combination with other ARVs. PREZISTA/r is not recommended for use in patients with severe hepatic impairment.

About the ARTEMIS study

ARTEMIS (AntiRetroviral Therapy with TMC114 examined in naive subjects) is an international ongoing, randomized, controlled, open-label non-inferiority
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SOURCE Tibotec Therapeutics
Copyright©2008 PR Newswire.
All rights reserved

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