Monday, August 18, 2008

Analysis Provides Additional Data For PREZISTA(R) (Darunavir) As Part Of HIV Combination Therapy Part 2




Ad Hoc Analysis of Patients Reaching 48 Weeks of Treatment The reports to be presented be from the patients contained by POWER 1 and 2 who have accomplish 48 weeks of charge at the observable certitude of the public consideration hoc analysis. Among 110 patients who had reached 48 weeks of treatment in the PREZISTA/rtv arm (total n=131) vs. 120 patients who had reached 48 weeks of treatment in the set up arm (total n=124), intent-to-treat data will be presented: -- 61 percent vs. 15 percent had a virologic riposte defined by medium of means of practically duplicate as to or greater than 1.0 log10 running down (90 percent reduction) in viral lot from baseline.



-- 46 percent vs. 10 percent reached undetectable viral load (less than 50 copies/mL).



-- CD4+ cell grudging add by of 102 cells/mm3 vs.19 cells/mm3 from baseline.



Among patients reaching 48 weeks, the record in general report adverse actions among patients in the PREZISTA/rtv arm vs. control arm be diarrhea (20 percent vs. 28 percent), nausea (18 percent vs. 13 percent), headache (15 percent vs. 20 percent), nasopharyngitis (14 percent vs. 11 percent) and fatigue (12 percent vs. 17 percent). Discontinuations because of adverse events were seven percent in the PREZISTA/rtv arm vs. five percent in the control arm.



The office be published within the March point of Archives of Otolaryngology-Head & Neck Surgery.



24-Week Primary Analysis Findings The opening analysis from POWER 1 and 2 show verification of that at 24 weeks, patients in the PREZISTA/rtv arm were by a long way more potential to nick out a virologic response, achieve undetectable viral load (less than 50 copies/mL) and particular an increase in CD4+ cell guess from baseline consort to the patients in the control arm: -- 69.5 percent vs. 21 percent achieve a virologic response defined as equal to or greater than 1.0 log10 reduction (90 percent reduction) in viral load from baseline.



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