HIV/AIDS Update - Dutrebis approved, though not commercially marketed in US at this time

"U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx> · Mon, 09 Feb 2015 17:39:10 -0600

Title:     HIV/AIDS Update - Dutrebis approved, though not commercially marketed in US at this time

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  On February 6, 2015, the FDA approved Dutrebis a fixed dose combination tablet containing 150 mg of lamivudine and 300 mg of raltegravir. Dutrebis tablet is approved for use in combination with other antiretroviral products for the treatment of HIV-1 infection in adults and pediatric patients greater than or equal to 6 years of age weighing at least 30 kg. The recommended dosage of Dutrebis is one tablet taken twice daily with or without food.
Dutrebis approval was based on an open-label, single dose, randomized, two-period, crossover study in healthy subjects (n=108). One Dutrebis fixed dose combination table was shown to provide comparable lamivudine and raltegravir exposures to one Epivir 150 mg tablet plus on Isentress 400 mg tablet. Due to the higher bioavailability of raltegravir contained in Dutrebis, the exposures provided by the 300 mg dose of raltegravir are comparable to 400 mg of ralegravir given as the raltegravir poloxamer formulation (Isentress), which accounts for the difference in raltegravir dose.
Clinical trials have not been specifically performed with Dutrebis. The indication of Dutrebis is based on efficacy and safety data demonstrated in clinical trials with lamivudine and with raltegravir.
According to the manufacturer, Merck Pharmaceuticals, Dutrebis, will not be made commercially available in the U.S. at this time.
Richard Klein
Office of Health and Constituent Affairs
Food and Drug Administration
Kimberly Struble
Division of Antiviral Products
Food and Drug Administration
Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration

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