HIV :: PREZISTA Phase III Study meets primary objective in HIV patients

Results from a Phase 3 head-to-head study showed that a significantly greater percent (77 percent) of treatment-experienced HIV-1 infected adults* taking Prezista? (darunavir)/ritonavir, with an optimised background regimen (OBR) of antiretroviral agents, reached a viral load of less than 400 copies/mL at week 48, compared to 68 percent of patients taking the widely prescribed medication lopinavir/ritonavir, with OBR, in a per-protocol analysis (95 percent confidence interval 2-16). In addition, significantly more patients receiving darunavir/r in this study reached an undetectable viral load (<50 copies/mL) compared to patients taking lopinavir/r (71 percent vs. 60 percent).The 48-week efficacy and safety results, published in the 7 July 2007 issue of The Lancet, will also be presented at the 4th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2007) in Sydney, Australia on 24 July 2007.The study met both the primary and secondary objective of non-inferiority and superiority. The primary objective was to demonstrate non-inferiority in virologic response with darunavir/ritonavir versus lopinavir/ritonavir, both combined with an individualised OBR, at week 48. If non-inferiority was established, the secondary objective was to demonstrate superiority in virologic response with darunavir/ritonavir versus lopinavir/ritonavir at week 48. Virologic response was defined as a confirmed plasma viral load of <400 copies/mL“The POWER studies have shown us that darunavir is an option for highly treatment experienced patients, and the results of TITAN demonstrate that darunavir is also a treatment option for patients with early virological failure, which is representative of patients commonly encountered in clinical practice,” said Jos? Valdez Madruga, M.D., Centro de Referencia e Treinamento DST/AIDS, Mariana-S?o Paulo, Brazil.Prezista, co-administered with low dose ritonavir (r), is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in highly pre-treated adult patients who failed more than one regimen containing a protease inhibitor (PI). Prezista is currently approved in several areas including the United States, Canada, and the European Union, among others, and applications for approval also have been submitted or are planned for submission in many other countries.

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