The US Food and Drug Administration (FDA) has approved Gilead Sciences' fixed-dose HIV combination pill Odefsey containing emtricitabine 200 mg, rilpivirine 25 mg, and tenofovir alafenamide (TAF; 25 mg), the company announced.
Odefsey is Gilead's second TAF-based regimen to receive FDA approval "and represents the smallest pill of any single tablet regimen for the treatment of HIV," the company said in a news release.
"TAF is a novel targeted prodrug of tenofovir that has demonstrated high antiviral efficacy similar to and at a dose less than one-tenth that of Gilead's Viread (tenofovir disoproxil fumarate, TDF). TAF has also demonstrated improvement in surrogate laboratory markers of renal and bone safety as compared to TDF in clinical trials in combination with other antiretroviral agents. 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 percent less tenofovir in the bloodstream," the company added.
Gilead's first TAF-based regimen to be approved was Genvoya, containing elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg, and TAF 10 mg.
"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 less than or equal to 100,000 copies/mL," the company said.
Odefsey may also replace a stable antiretroviral regimen in virologically suppressed patients (HIV-1 RNA <50 copies/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.
The recommended dosage of Odefsey is one tablet once daily with a meal in adults and children 12 years of age and older with body weight greater than or equal to 35 kg and a creatinine clearance 30 mL/minute or higher. Odefsey is not recommended in patients with estimated creatinine clearance lower than 30 mL/minute.
Odefsey has a boxed warning regarding the risks for lactic acidosis/severe hepatomegaly with steatosis and posttreatment acute exacerbation of hepatitis B. Before starting the drug, patients should be tested for hepatitis B virus infection. Estimated creatinine clearance, urine glucose, and urine protein should also be assessed before starting Odefsey and should be monitored during therapy in all patients.
Odefsey is contraindicated when coadministered with the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, and phenytoin; the antimycobacterials rifampin and rifapentine; proton pump inhibitors such as dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, and rabeprazole; the glucocorticoid systemic dexamethasone (more than a single dose); and John's wort (Hypericum perforatum).
Full prescribing information for Odefsey is available on the Gilead website.
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Cite this: FDA Clears Gilead's Second TAF-Based HIV Regimen (Odefsey) - Medscape - Mar 02, 2016.