Two phase 3b trials evaluating Odefsey (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg, Gilead Sciences) for the treatment of patients with human immunodeficiency virus-1 (HIV-1) infection have met their primary objectives. The ongoing studies were designed to assess the efficacy and safety of Odefsey in virologically suppressed adults switching from the tenofovir disoproxil fumarate (TDF)-based regimens Complera (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir disoproxil fumarate 300 mg, Gilead Sciences) (Study 1216) or Atripla (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg, Bristol-Myers Squibb/Gilead) (Study 1160). Odefsey combines Gilead’s emtricitabine and tenofovir alafenamide with rilpivirine (Janssen Sciences Ireland).
Odefsey maintained rates of virological suppression that were similar to those of the TDF-based regimens in both studies, based on the proportion of patients with HIV-1 RNA levels (viral load) of less than 50 copies/mL. At week 48, virological suppression was maintained in 94% of patients taking Odefsey and in 94% of patients taking Complera in Study 1216 (difference: –0.3%), and in 90% of patients taking Odefsey compared with 92% of patients taking Atripla in Study 1160 (difference: –2.0%).
Compared with the TDF-based regimens, Odefsey demonstrated significant improvements in bone mineral density (BMD) at the hip and spine (P < 0.001) in both studies. In addition, improvements in total and tubular proteinuria statistically favored Odefsey in both studies (P < 0.001).
The most commonly reported adverse events for Odefsey included upper respiratory tract infection, diarrhea, nasopharyngitis, cough, and headache.
Odefsey was approved in the United States in March 2016 and is indicated as a complete regimen for the treatment of HIV-1 infection in patients 12 years of age and older who have no antiretroviral treatment history and HIV-1 RNA levels of less than or equal to 100,000 copies/mL. Odefsey is also indicated as replacement for a stable antiretroviral regimen in patients who are virologically suppressed (HIV-1 RNA of less than 50 copies/mL) for at least six months with no history of treatment failure and no known resistance to the individual components of Odefsey. No dosage adjustment of Odefsey is required in patients with an estimated creatinine clearance of 30 mL per minute or greater.
Odefsey has a boxed warning in its product label regarding the risks of lactic acidosis or severe hepatomegaly with steatosis, and post-treatment acute exacerbation of hepatitis B.
Source: Gilead Sciences; July 21, 2016.
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