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Gilead’s Odefsey (Emtricitabine, Rilpivirine, Tenofovir Alafenamide) Meets Primary 48-Week Objective in Two Phase 3b Studies
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Odefsey maintained similar rates of virologic suppression as the TDF-based regimens in both studies based on the proportion of patients with HIV-1 RNA levels (viral load) <50 copies/mL. At Week 48, virologic suppression was maintained in 94 percent of patients taking Odefsey and in 94 percent of patients taking Complera in Study 1216 (difference: -0.3 percent; 95 percent CI: -4.2 percent to +3.7 percent), and in 90 percent of patients taking Odefsey versus 92 percent of patients taking Atripla in Study 1160 (difference: -2.0 percent; 95 percent CI: -5.9 percent to +1.8 percent).Compared to the TDF-based regimens, Odefsey demonstrated statistically significant improvements in bone mineral density (BMD) at the hip and spine (p<0.001) in both studies. Additionally, improvements in total and tubular proteinuria statistically favored Odefsey in both studies (p<0.001). Study regimens were generally well tolerated, and general safety and discontinuation rates due to adverse events were comparable in the two studies. The most commonly reported adverse events for Odefsey included upper respiratory tract infection, diarrhea, nasopharyngitis, cough and headache. Gilead plans to submit these data for presentation at scientific conferences in 2016.
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Jul 21, 2016
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Related Keywords Emtricitabine, Rilpivirine, Tenofovir Alafenamide, Phase 3b Studies, Tenofovir Disoproxil Fumarate, Complera, Respiratory Tract Infection, Diarrhea, Nasopharyngitis, Cough, Headache