FDA Approves Odefsey for the Treatment of HIV-1

Odefsey is the second tenofovir alafenamide-based regimen to be approved by the FDA
Odefsey is the second tenofovir alafenamide-based regimen to be approved by the FDA

Gilead Sciences announced that the Food and Drug Administration (FDA) has approved Odefsey (emtricitabine/rilpivirine/tenofovir alafenamide [R/F/TAF]) tablets for the treatment of HIV-1 infection in certain patients. 

Odefsey is indicated as a complete regimen for the treatment of HIV-1 in patients ≥12 years old who have no antiretroviral treatment history and HIV-1 RNA levels ≤100,000 copies/mL. It is also indicated as replacement for a stable antiretroviral regimen for those who are virologically suppressed (defined as HIV-1 RNA levels <50 copies/mL) for ≥6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Odefsey.

Odefsey combines emtricitabine and tenofovir alafenamide, both HIV nucleoside analog reverse transcriptase inhibitors (NRTIs), and rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI).

RELATED: Gilead Announces Tenofovir Alafenamide Phase 3 Study Results

The FDA approval was based on a bioequivalence study that showed Odefsey achieved similar blood drug levels of emtricitabine and TAF as Genvoya (elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide; Gilead Sciences) and similar drug levels of rilpivirine as Edurant (rilpivirine). Its safety, efficacy, and tolerability have been supported by clinical studies of rilpivirine-based therapy and F/TAF-based therapy in various patient populations with HIV: treatment-naive adults and adolescents, virologically suppressed adults who switched from PI-, NNRTI-, and INSTI-based regimens, and virologically suppressed adults with mild-to-moderate renal impairment. 

Odefsey is the second tenofovir alafenamide-based regimen to be approved by the FDA and is also the smallest pill of any single-tablet regimen for the treatment of HIV. 

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

For more information call (800) GILEAD-5 or visit Odefsey.com.

 

RELATED: Gilead Announces Tenofovir Alafenamide Phase 3 Study Results

 

The FDA approval was based on a bioequivalence study that showed Odefsey achieved similar blood drug levels of emtricitabine and TAF as Genvoya (elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide; Gilead Sciences) and similar drug levels of rilpivirine as Edurant (rilpivirine). Its safety, efficacy, and tolerability have been supported by clinical studies of rilpivirine-based therapy and F/TAF-based therapy in various patient populations with HIV: treatment-naive adults and adolescents, virologically suppressed adults who switched from PI-, NNRTI-, and INSTI-based regimens, and virologically suppressed adults with mild-to-moderate renal impairment. 


Odefsey is the second tenofovir alafenamide-based regimen to be approved by the FDA and is also the smallest pill of any single-tablet regimen for the treatment of HIV. 


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

 

For more information call (800) GILEAD-5 or visit Odefsey.com.

 

RELATED: Gilead Announces Tenofovir Alafenamide Phase 3 Study Results

 

The FDA approval was based on a bioequivalence study that showed Odefsey achieved similar blood drug levels of emtricitabine and TAF as Genvoya (elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide; Gilead Sciences) and similar drug levels of rilpivirine as Edurant (rilpivirine). Its safety, efficacy, and tolerability have been supported by clinical studies of rilpivirine-based therapy and F/TAF-based therapy in various patient populations with HIV: treatment-naive adults and adolescents, virologically suppressed adults who switched from PI-, NNRTI-, and INSTI-based regimens, and virologically suppressed adults with mild-to-moderate renal impairment. 


Odefsey is the second tenofovir alafenamide-based regimen to be approved by the FDA and is also the smallest pill of any single-tablet regimen for the treatment of HIV. 


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

 

For more information call (800) GILEAD-5 or visit Odefsey.com.

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