FDA Approves Single-Tablet Regimen Odefsey for Treatment of HIV-1 Infection

FDA Approves Single-Tablet Regimen Odefsey for Treatment of HIV-1 Infection

Combo pill demonstrates antiviral efficacy at one-tenth the dose of Viread


The FDA has given the nod to Odefsey (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg) for the treatment of human immunodeficiency virus-1 (HIV-1) infection in certain patients. Emtricitabine and tenofovir alafenamide [TAF] are from Gilead Sciences, and rilpivirine is from Janssen Sciences Ireland. Odefsey is Gilead’s second regimen based on TAF, a tenofovir prodrug, to receive FDA approval.

Odefsey 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 per mL. Odefsey is also indicated as a replacement for a stable antiretroviral regimen in patients who are virologically suppressed (HIV-1 RNA of less than 50 copies per mL) for at least six months, with no history of treatment failure and no known substitutions associated with resistance to the individual components of Odefsey. No dosage adjustment of Odefsey is required in patients with an estimated creatinine clearance of greater than or equal to 30 mL per minute.

Odefsey has a boxed warning in its product label regarding the risks of lactic acidosis/severe hepatomegaly with steatosis, and post-treatment acute exacerbation of hepatitis B.

TAF has demonstrated high antiviral efficacy similar to and at a dose less than one-tenth that of Gilead’s tenofovir disoproxil fumarate (TDF, Viread). TAF has also demonstrated improvement in surrogate laboratory markers of renal and bone safety compared with TDF in clinical trials in combination with other antiretroviral agents. Data have shown that because TAF enters cells, including HIV-infected cells, more efficiently than does TDF, it can be given at a much lower dose, with 90% less tenofovir in the bloodstream.

The FDA’s approval was based on the results of a bioequivalence study in which Odefsey achieved drug levels of emtricitabine and TAF in the blood similar to that of Genvoya (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg, Gilead Sciences) and similar drug levels of rilpivirine compared with Edurant (rilpivirine 25 mg, Johnson & Johnson/Janssen).

Odefsey does not cure HIV infection or acquired immune deficiency syndrome (AIDS).

Source: Gilead Sciences; March 1, 2016.

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