суббота, 9 августа 2008 г.

Aptivus(R) (tipranavir) Capsules Granted Full Approval By The U.S. FDA Part 2




-- Use notify when prescribe APTIVUS/r surrounded by patients who may be at stake in favour of increased bleeding or who be acknowledgment medication set to mortgage the risk of bleeding.



-- The risk-benefit of APTIVUS/r have not be verified in pediatric patients.



There are no organization grades demonstrating the effect of APTIVUS/r against clinical increase of HIV-1.



IMPORTANT INDICATION AND SAFETY INFORMATION FOR COMBIVIR, EPZICOM, AND LEXIVA HIV tablets achieve not remedy HIV infection/AIDS or dowel endorsement HIV to others.



About RESIST The RESIST clinical deliberation program consists of two ongoing Phase 3 pivotal trial, RESIST-1 and RESIST-2. Comprising one of the largest study programs conduct in treatment-experienced HIV patients, RESIST-1 pillage in 620 patients in the U.S., Canada and Australia, and RESIST-2 includes 863 patients in Europe and Latin America. The trial logo and baseline biddable characteristics are comparable across study. Patients enrol in the RESIST studies be failing their popular PI-based regimen, have received at lowest two foregoing PI-based regimen, had received prior coverage from at least three classes of antiretroviral agents and had well-known PI chafing.



At the incident of supplied approval, the studies examine treatment comeback, defined by a confirmed 1 log10 or greater call upon a halt in the amount of HIV in the blood, or viral delivery, at 48 weeks versus a comparator commission where patients received one of several market ritonavir-boosted PIs. Investigators select a comparator PI (CPI/r) that offered patients the convincing opportunity for treatment response foundation on resistance conduct tests. The comparator PIs were lopinavir, indinavir, saquinavir and amprenavir. In totalling, patients in both guns received an optimized milieu regimen of other antiretroviral drugs. Patients were treatment-experienced and the majority (85.1%) were at least credibly impervious to the comparator PI set.



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