The Food and Drug Administration (FDA) approved Gilead Sciences Inc's Truvada (tenofovir disoproxil/emtricitabine), fixed-dose combination treatment for HIV-1 infection. Control of HIV/AIDS generally requires simultaneous use of three or more drugs from different classes. Combination products bring together different HIV/AIDS drugs in a single medication or co-package and help make treatment regimens less complicated for patients to follow, an FDA release said.
"Simplifying treatment regimens by reducing the number of pills and times per day patients need to take them provides significant public health benefits," Dr. Crawford added.
Truvada is indicated for use in combination with other antiretroviral drug products from different classes such as non-nucleoside reverse transcriptase inhibitors or protease inhibitors for the treatment of adults with HIV-1 infection.
Truvada is a fixed-dose combination of the antiretroviral drugs tenofovir disoproxil fumarate 300mg and emtricitabine 200mg, both of which are approved individually under the brand names Viread and Emtriva, respectively. The approval of Truvada is based on data demonstrating therapeutic equivalence between the combination product and the individual products.
FDA completed its review of Truvada in 4 months. Gilead Sciences Inc submitted their New Drug Application (NDA) for Truvada in March 2004.