Gilead has applied to the US Food and Drug Administration for approval of a new version of Truvada. The upgraded compound replaces tenofovir disoproxil fumarate (TDF) with tenofovir alafenamide (TAF). As already mentioned, TAF has a more favourable side-effect profile than TDF.
The application is backed by phase III clinical trials in which the improved formulation proved non-inferior in its ability to suppress HIV. However, Gilead has not filed for approval of the new Truvada as a pre-exposure prophylaxis as there have been no clinical trials of the tablet for that purpose. The drug — which will go under a new name — is only intended for use with other antiretrovirals to treat HIV in people age 12 or older.