Tibotec drugs fight resistant HIV in study

Results from the primary analysis of the Phase III study showed that 77% of treatment-experienced HIV-1 infected adults taking Prezista (darunavir) 600mg tablets with 100mg Prezista/r (ritonavir) twice daily, plus an optimized background regimen of antiretroviral agents (ARV), reached a plasma viral load of <400 copies/mL at week 48, compared to 68% of patients taking Abbott Laboratories' protease inhibitor Kaletra. The multinational phase III clinical trial, which involved 18 nations and more than 30 centers in the US, is the first trial to offer patients infected with resistant HIV the potential of receiving two investigational new drugs together to fight the disease. "This is exciting new information that adds to the body of knowledge on Prezista in a much broader group of treatment-experienced patients," said Daniel Berger, medical director of NorthStar Healthcare and clinical assistant professor of medicine at the University of Illinois, Chicago. The 48-week primary analysis from the study provides additional information regarding efficacy and safety of Prezista/r in combination with other ARV agents for the treatment of HIV infection in treatment-experienced adult patients. The use of Prezista/r therapy in this broader range of treatment-experienced patients has not been approved by the FDA. These results will be submitted to the FDA as part of the post-marketing commitment to support the traditional approval of Prezista, Tibotec said.