Gilead plans to file for approval of novel HIV drug in the United States and Europe this year.
Emtricitabine/tenofovir alafenamide (FTC/TAF) used in combination with the investigational drug bictegravir met primary endpoints in 4 late-stage clinical trials.
Gilead said it plans to submit marketing applications for the combination in the second quarter in the United States and in the third quarter in the EU, according to Reuters.
Three of the 4 studies examined the safety and efficacy of the combination against a regimen that contained dolutegravir in treatment-naïve patients with HIV.
The fourth trial compared virologically suppressed patients previously treated with antiretrovirals who had switched to the Gilead combination therapy to patients on a different regimen.
The results of the study showed that the combination therapy was as effective as GlaxoSmithKline’s dolutegravir. Furthermore, it was well-tolerated and none of the participants discontinued treatment due to renal events.
“If the results point to superiority (rather than non-inferiority) for Gilead’s drug it will likely be taken negatively (for GSK),” Berenburg analysts noted.
The bictegravir and FTC/TAF combination is intended to treat HIV with a single-tablet regimen, MarketWatch reported.
Gilead commented that the latest results “could represent an important advance in triple-therapy treatment for a broad range of HIV patients.”
US shares of GSK were up 1.4% at $43.27 in early trading, Reuters reported.