Study 1489 shows 96 week results Biktarvy in adults new to HIV therapy.- Gilead Sciences

Gilead Sciences, Inc. announced 96-week results from a Phase III, randomized, double-blinded study (Study 1489) evaluating the safety and efficacy of Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets) for the treatment of HIV-1 infection in treatment-na�ve adults. In the ongoing study, Biktarvy was found to be statistically non-inferior to a regimen of abacavir/dolutegravir/lamivudine (600/50/300mg, ABC /DTG/3TC) through 96 weeks of therapy. The data will be presented during a late-breaking abstract session at the IDWeek 2018 conference in San Francisco .

In Study 1489, treatment-na�ve adults (n=629) were randomized 1:1 in a blinded fashion to receive Biktarvy (BIC/FTC/TAF) or ABC /DTG/3TC. At Week 96, non-inferiority was maintained from the primary endpoint measurement at Week 48, with 87.9 percent (n=276/314) of patients taking Biktarvy and 89.8 percent (n=283/315) of patients taking ABC /DTG/3TC achieving HIV-1 RNA levels less than 50 copies/mL (difference: -1.9 percent, 95 percent CI: -6.9 percent to 3.1 percent, p=0.45). In the resistance analysis population, none of the study participants randomized to Biktarvy developed treatment-emergent resistance. There were no renal discontinuations and no cases of proximal renal tubulopathy or Fanconi syndrome in the Biktarvy treatment group.

The median change in estimated glomerular filtration rate (eGFR) from baseline to Week 96 was significantly less with Biktarvy compared with ABC /DTG/3TC (-7.8 mL/min vs. -9.6 mL/min, p=0.01). Median changes in proteinuria were similar between both treatment groups. Additionally, the mean percent changes from baseline in spine and hip bone mineral density in the Biktarvy group were similar to ABC /DTG/3TC group (spine: -0.71 vs. -0.22, p=0.14; hip: -1.13 vs. -1.26, p=0.59). Biktarvy was well tolerated through Week 96. Discontinuations due to adverse events were low in both groups (0.0 percent (n=0) for Biktarvy vs. 2 percent (n=5) for ABC /DTG/3TC). The most commonly reported adverse events (all grades) were nausea (11 percent for Biktarvy vs. 24 percent for ABC /DTG/3TC), diarrhea (15 percent vs. 16 percent) and headache (13 percent vs. 16 percent). Study 1489 is ongoing and will remain randomized and blinded through 144 weeks.