FDA has approved Odefsey (Gilead Sciences, Inc.) for the treatment of HIV-1 infection in certain patients. Here are the top 7 facts to know about Odefsey.
FDA recently approved Odefsey (Gilead Sciences, Inc.) for the treatment of HIV-1 infection in certain patients.
The fixed-dose combination pill containing emtricitabine 200 mg, rilpivirine 25 mg, and tenofovir alafenamide (TAF) 25 mg. Emtricitabine and TAF are manufactured by Gilead Sciences and rilpivirine is from Janssen Sciences Ireland UC.
With the new approval, Odefsey is now indicated as a complete regimen for the treatment of HIV-1 infection in patients aged 12 years and older who have no antiretroviral treatment history and HIV-1 RNA levels less than or equal to 100,000 copies per milliliter.
“As people are living longer with HIV, there is an increasing need to develop new treatments that are tolerable and help address long-term health for patients,” said John C. Martin, PhD, chairman and CEO of Gilead Sciences.
Here are the top 7 facts to know about Odefsey:
1. The anticipated availability and pricing of the drug is currently undetermined.
2. Odefsey is the smallest pill of any single tablet regimen for the treatment of HIV. The recommended dosing regimen for patients aged 12 years and older (≥35 kg) is one tablet taken orally once daily with a meal. Odefsey is not recommended for use in patients with a creatinine clearance (CrCl) < 30 mL per minute.
3. The combination is also indicated as replacement for 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.
4. Odefsey is Gilead’s second TAF-based regimen approved by FDA. The first was Genvoya, approved in November, 2015, which contains elvitegravir, cobicistat, emtricitabine, and TAF.
5. TAF is a novel targeted prodrug of tenofovir that has demonstrated high antiviral efficacy similar to and at a lower dose than that of Gilead’s Viread (tenofovir disoproxil fumurate, TDF). Data show that because TAF enters cells, including HIV-infected cells, more efficiently than TDF, it can be given at a much lower dose and there is 90% less tenofovir in the bloodstream.
6. FDA’s approval of Odefsey is based on a bioequivalence study demonstrating that the medication achieved similar drug levels of emtricitabine and TAF in the bloodstream as Genvoya and similar drug levels of ripilvirine as Edurant (ripilvirine 25 mg).
7. The most common adverse reactions associated with the use of rilpivirine are depressive disorders, insomnia, and headache. The most common adverse reaction with emtricitabine and TAF is nausea. Odefsey labelling also contains a boxed warning regarding the risks of lactic acidosis/ severe heptomegaly with steatosis, and post treatment acute exacerbation of hepatitis B.
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