Gilead has unveiled data from a batch of late-stage trials showing that its investigational HIV therapy bictegravir was non-inferior to ViiV Healthcare’s flagship drug dolutegravir in suppressing levels of the virus.
Three of the ongoing Phase III studies are designed to explore the efficacy and safety of bictegravir in combination with emtricitabine/tenofovir alafenamide (F/TAF; brand name Descovy) compared to regimens containing dolutegravir (brand name Tivicay) among treatment-naïve patients and among virologically suppressed patients switching from an existing antiretroviral regimen.
A fourth ongoing study in virologically suppressed patients is comparing switching to the bictegravir fixed-dose regimen versus remaining on a suppressive regimen of two nucleoside/nucleotide reverse transcriptase inhibitors and a boosted protease inhibitor.
The company said that in all four Phase III studies the regimen of containing Gilead’s integrase inhibitor plus F/AF achieved non-inferiority in efficacy. Full results are to be presented at scientific meetings this year.
“This investigational single tablet regimen brings together the potency of an integrase inhibitor, bictegravir, with the demonstrated efficacy and safety profile of the F/TAF backbone,” said Norbert Bischofberger, executive vice president of , R&D and chief scientific officer of Gilead.
“Based on the results from these Phase III studies, the combination of bictegravir and F/TAF could represent an important advance in triple-therapy treatment for a broad range of HIV patients, and we look forward to submitting regulatory applications in the US and EU this year.”
The firm confirmed that it is planning to submit a new drug application in the US for the second quarter of this year, while a marketing application is planned for Europe in the third quarter.
Berenberg analysts believe annual bictegravir sales could reach $3.8 billion by 2020, thus taking a sizeable chunk of the market, according to Reuters.