Odefsey Labeling Updated with New Data, Monitoring Recommendations

Updated with data from trials in which patients were switched to Odefsey from TDF-based regimens
Updated with data from trials in which patients were switched to Odefsey from TDF-based regimens

The Food and Drug Administration (FDA) has approved labeling changes for Odefsey (emtricitabine/rilpivirine/tenofovir alafenamide; Gilead) to include data from trials in which patients were switched to Odefsey from tenofovir disoproxil fumarate (TDF)-based regimens (Complera [emtricitabine/rilpirivine/TDF; Gilead] or Atripla [efavirenz/emtricitabine/TDF; Bristol-Myers Squibb and Gilead]).

In Study 1216, the efficacy and safety of switching from emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) to Odefsey were evaluated in a randomized, double-blind study of virologically-suppressed HIV-1 infected adults. Patients were suppressed (HIV-1 RNA <50 copies/mL) on their baseline regimen of FTC/RPV/TDF for at least 6 months and had no documented resistance mutations to FTC, TAF, or RPV prior to study entry. They were randomized to either switch to Odefsey (n=316) or stay on FTC/RPV/TDF (n=314).  At Week 48, 94% of patients in both groups had HIV-1 RNA <50 copies/mL. Patients who switched to Odefsey also saw an increase in bone mineral density (BMD) (1.61% lumbar spine, 1.04% total hip) compared to those in the FTC/RPV/TDF arm who remained stable or experienced a decrease (0.08% lumbar spine, –0.25% total hip).

In Study 1160, the efficacy and safety of switching from efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) to Odefsey were evaluated in a randomized, double-blind study of virologically-suppressed HIV-1 infected adults. Patients were suppressed (HIV-1 RNA <50 copies/mL) on their baseline regimen of EFV/FTC/TDF for at least 6 months and had no documented resistance mutations to FTC, TAF, or RPV prior to study entry. They were randomized to either switch to Odefsey (n=438) or stay on EFV/FTC/TDF (n=437). At Week 48, 90% of patients in the Odefsey group had HIV-1 RNA <50 copies/mL versus 92% of patients who remained on EFV/FTC/TDF. Patients who switched to Odefsey saw an increase in BMD (1.65% lumbar spine, 1.28% total hip) compared to patients who remained on EFV/FTC/TDF who experienced a slight decrease
(–0.05% lumbar spine, –0.13% total hip).

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In addition, the labeling includes information regarding renal laboratory tests and serum lipid changes in patients involved in these two trials. 

Section 2.1, related to Dosing and Administration, has also been revised to now state: It is recommended that serum creatinine, serum phosphorus, estimated creatinine clearance, urine glucose, and urine protein should be assessed before initiating Odefsey and during therapy in all patients as clinically appropriate.

For more information visit Odefsey.com.