Drug updated on 4/26/2024
| Dosage Form | Tablet (emtricitabine/ rilpivirine/tenofovir alafenamide; 200 mg/25 mg/ 25 mg) |
| Drug Class | HIV nucleoside analog reverse transcriptase inhibitors and non-nucleoside reverse transcriptase inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated as a complete regimen for the treatment of HIV-1 infection in patients weighing at least 35kg as initial therapy in those with no antiretroviral treatment history with HIV-1 RNA less than or equal to 100,000 copies per mL; or to replace a stable antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of ODEFSEY.
Summary
- Emtricitabine, rilpivirine, and tenofovir alafenamide (Odefsey) is indicated as a complete regimen for the treatment of HIV-1 infection in patients weighing at least 35kg. It can be used as initial therapy in those with no antiretroviral treatment history with HIV-1 RNA less than or equal to 100,000 copies per mL, or to replace a stable antiretroviral regimen in those who are virologically suppressed.
- One study is associated with this drug, focusing on Randomized Controlled Trials.
- Odefsey has demonstrated noninferior efficacy compared to other regimens such as RPV/FTC/TDF or EFV/FTC/TDF in maintaining virological suppression (HIV-1 RNA < 50 copies/mL) at 96 weeks.
- In terms of safety and tolerability, Odefsey showed significant improvements, especially concerning bone mineral density and renal tubular markers when compared to baseline therapies like RPV/FTC/TDF and EFV/FTC/TDF.
- No participants on the Odefsey regimen developed treatment-emergent resistance. However, there were instances of resistance development among participants continuing with EFV/FTC/TDF and one instance with RPV/FTC/TDF. This suggests that Odefsey might offer an advantage in minimizing the risk of developing resistance against HIV medications.
- Studies have included adults who were already virologically suppressed, indicating that emtricitabine, rilpivirine, and tenofovir alafenamide could be suitable for a broad range of patients looking to switch their current regimen due to possibly related reasons including safety concerns.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Odefsey (emtricitabine, rilpivirine, and tenofovir alafenamide) Prescribing Information. | 2021 | Gilead Sciences, Inc. Foster City, CA |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| Switching to coformulated rilpivirine (RPV), emtricitabine (FTC) and tenofovir alafenamide from either RPV, FTC and tenofovir disoproxil fumarate (TDF) or efavirenz, FTC and TDF: 96-week results from two randomized clinical trials. | 1,505Subjects F: 12% M: 88% | 2018 | HIV Medicine |
Sex Distribution:
F:12%
M:88%
1505Subjects
Year:
2018
Source:HIV Medicine