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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

ith HIV medications and had a viral load greater than 5,000 copies. Overall the study population had a mean baseline viral load of 4.85 log10 copies per mL and a median CD4+ cell count of 225 cells per cubic millimeter.

Patients were randomized to receive PREZISTA/r 800 mg/100 mg once daily (n=343) or, based on approved dosing in each country, either lopinavir/r 800 mg/200 mg once daily or 400 mg/100 mg twice daily (n=346), plus a background regimen of tenofovir and emtricitabine once daily. Patient randomization was stratified based on viral load and CD4+ cell count.

ARTEMIS: 48-week study results

In the per-protocol analysis of 689 patients, among patients randomized to the once-daily PREZISTA/r arm (n=343) vs. the lopinavir/r arm (n=346), the 48-week analysis showed that:

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

viral load (<50 copies/mL) vs. 78 percent of patients in the

lopinavir/r arm.

-- The median change in CD4+ cell count from baseline was similar between

the PREZISTA/r and lopinavir/r arms (137 cells per cubic millimeter vs.

141 cells per cubic millimeter).

ARTEMIS: Safety findings

-- In the two study arms the adverse events at least Grade 2 in severity

included diarrhea, nausea and rash. Diarrhea was 4.1 percent in the

PREZISTA/r arm vs. 9.8 percent in the lopinavir/r arm. Nausea was 1.7

percent in the PREZISTA/r arm vs. 2.9 percent in the lopinavir/r arm.

Rash was 2.6 percent in the PREZISTA/r arm vs. 1.2 percent in the

lopinavir/r arm.

-- Incidence of Grade 3-4 lipid-related adverse events reported in

PREZISTA/r arm were 1.7 percent vs. 5.2 percent in the lopinavir/r arm.

-- In both treatment arms there was a low incidence of discontinuation.

Discontinuations due to adverse events were 3.4 percent in the

PREZISTA/r arm vs. 6.9 percent in the lopinavir/r arm.


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SOURCE Tibotec Therapeutics
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