Gilead presents new data on Biktarvy for tretment of HIV in women
Gilead Sciences presented findings from two Phase 3 trials - a trial demonstrating the effectiveness of switching to Biktarvy in women, and a trial evaluating the potential for the single tablet regimen to be an effective treatment option in virologically suppressed patients with known resistance to nucleo(s)tide or non-nucleo(s)tide reverse transcriptase inhibitors. The use of Biktarvy in patients with known drug resistance is investigational. These data were presented at the 10th International AIDS Society Conference on HIV Science being held in Mexico City. "These data presented at IAS provide new information about the treatment of HIV among women and patients with known drug resistance," said Diana Brainard, MD, Senior Vice President, HIV and Emerging Viruses, Gilead Sciences. "The studies further demonstrate the potential for Biktarvy to be an important treatment option for appropriate patients." This international multicenter, randomized, open-label Phase 3 trial evaluated 470 virologically suppressed women on a baseline regimen of either Genvoya, elvitegravir/cobicistat/F/TDF or atazanavir+ritonavir+F/TDF who switched 1:1 from these baseline regimens to Biktarvy. The primary endpoint for this study conducted exclusively in women, was previously presented, and demonstrated noninferior maintained virologic suppression, with a low frequency of serious adverse events and no emergent resistance at Week 48. All participants, including those on baseline regimens, switched to Biktarvy through Week 96. At Week 96, 99.5 percent of women who received Biktarvy throughout the study duration and 98.5 percent of women who switched to Biktarvy at Week 48 maintained virologic suppression, with no development of treatment-emergent resistance. Biktarvy was also shown to be well-tolerated with low frequencies of serious adverse events.