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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

EMIS clinical investigator.

PREZISTA, co-administered with 100 mg ritonavir (PREZISTA/r), and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection.

This indication is based on analyses of plasma HIV RNA levels and CD4+ cell counts from two controlled phase 3 trials of 48 weeks duration in antiretroviral treatment-naive and treatment-experienced patients and two controlled phase 2 trials of 96 weeks duration in clinically advanced, treatment-experienced patients.

In treatment-experienced patients, the following points should be considered when initiating therapy with PREZISTA/r: treatment history and, when available, genotypic or phenotypic testing, should guide the use of PREZISTA/r. The use of other active agents with PREZISTA/r is associated with a greater likelihood of treatment response.

The risks and benefits of PREZISTA/r have not been established in pediatric patients. No clinical studies have demonstrated the effect of PREZISTA/r on clinical progression of HIV-1.

ARTEMIS 96-Week Study Results

In the 96-week per-protocol analysis of 689 patients, PREZISTA/r 800/100 mg once daily was shown to be non-inferior to lopinavir/r 800/200 mg once daily or 400/100 mg twice daily in treatment-naive adults with HIV-1. In addition, in the intent-to-treat analysis, the study showed that:

-- 79 percent of patients in the PREZISTA/r arm reached an undetectable

viral load (<50 copies/mL) vs. 71 percent of patients in the

lopinavir/r arm, (p=0.012).

-- Of patients with baseline viral load greater than and equal to 100,000

copies/mL, 76 percent of patients in the PREZISTA/r arm reached an

undetectable viral load (<50 copies/mL) vs. 63 percent of patients in

the lopinavir/r arm, (p=0.023).

-- Of patients with baseline viral load less than 100,000 copies/mL, 81

percent of patients in the PR
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SOURCE Tibotec Therapeutics
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