Gilead said that if approved, this would be the second product that contains a complete HIV treatment regimen in a single once-daily tablet.
Gilead entered into a license and collaboration agreement with Tibotec for the development and commercialisation of the single-tablet regimen in July 2009.
Subject to regulatory approval, Gilead will assume the lead role in the manufacturing, registration, distribution and commercialisation of the single-tablet regimen worldwide, excluding the developing world and Japan.
Tibotec will be responsible for the commercialisation of TMC278 as a stand-alone product and will hold rights to co-promote the single-tablet regimen in these territories.
Tibotec submitted an NDA for US marketing approval of TMC278 for once-daily use with other antiretroviral agents on 23 July 2010.
Gilead chairman and CEO John Martin said that combination antiretroviral therapy has dramatically advanced the field of HIV medicine, but the need remains for new single-tablet regimens that are effective, safe and well tolerated.