Gilead announced that two Phase 3b switch studies evaluating Odefsey (emtricitabine, rilpivirine, tenofovir alafenamide) for the treatment of HIV-1 infection met their primary objectives.

Study 1216 (n=630) and Study 1160 (n=875) were intended to evaluate the safety and efficacy of Odefsey among virologically suppressed adults switching from tenofovir disoproxil fumarate (TDF)-based regimens Complera (emtricitabine, rilpivirine, TDF) or Atripla (efavirenz, emtricitabine, TDF), respectively. These studies are ongoing.

For both studies, treatment with Odefsey maintained similar rates of virologic suppression as the TDF-based regimens based on the proportion of patients with HIV-1 RNA levels <50 copies/mL. At Week 48, virologic suppression was maintained in 94% of patients taking Odefsey and in 94% of patients taking Complera (difference –0.3%, 95% CI: –4.2% to 3.7%). In Study 1160, virologic suppression was maintained in 90% of patients taking Odefsey vs. 92% of patients taking Atripla (difference –2.0%, 95% CI: –5.9 to 1.8%). 

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Odefsey showed statistically significant improvements in bone mineral density at the hip and spine (P<0.001) in both studies. Also, improvements in total and tubular proteinuria statistically favored Odefsey for both studies (P<0.001).  

Overall, study regimens were generally well tolerated, and general safety and discontinuation rates due to adverse events were comparable in the two studies.

Odefsey was approved in March 2016 as a complete regimen to treat HIV-1 infections in patients aged ≥12 years who have no antiretroviral treatment history and HIV-1 RNA levels ≤100,000 copies/mL. It is also indicated as replacement therapy for a stable antiretroviral regimen in those who are virologically suppressed for at least 6 months with no history of treatment failure and no known resistance to the individual components of Odefsey.

Odefsey is available as 200mg/25mg/25mg fixed-dose tablets in 30-count bottles. 

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