Study 1844 Phase III results show Biktarvy efficacy in patients with HIV.- Gilead Sciences.

Gilead Sciences announced detailed 48-week results from a Phase III study (Study 1844) evaluating the efficacy and safety of switching from a regimen containing abacavir, dolutegravir and lamivudine (600/50/300mg) (ABC/DTG/3TC) to Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg), a once-daily single tablet regimen, in virologically suppressed adults with HIV.

Through Week 48, Biktarvy was found to be statistically non-inferior to ABC/DTG/3TC with a numerically lower incidence of mild or moderate study drug-related adverse events and no treatment-emergent resistance. At the primary endpoint of Week 48, switching to Biktarvy was non-inferior to continuing ABC/DTG/3TC with 1.1 percent in the Biktarvy arm and 0.4 percent in the ABC/DTG/3TC arm having HIV-1 RNA of at least 50 c/mL (difference: 0.7 percent; 95 percent CI: -1.0 percent to 2.8 percent, p=0.62); the proportion of patients with HIV-1 RNA below 50 c/mL was 93.6 percent in the Biktarvy arm and 95.0 percent in the ABC/DTG/3TC arm, according to FDA snapshot algorithm.

Patients in the Biktarvy arm had a lower incidence of study drug-related adverse events than those in the ABC/DTG/3TC arm (8 percent vs. 16 percent, p=0.006; all grades), which were primarily mild or moderate in severity. The difference between groups was primarily driven by numerically more drug-related gastrointestinal (flatulence, nausea, diarrhea) and neuropsychiatric (abnormal dreams and insomnia) adverse events in the ABC/DTG/3TC arm. The most common study drug-related adverse event was headache (3 percent in both arms). Few participants had adverse events leading to premature study discontinuation (2 percent vs. 1 percent).

Through Week 48, no patients in either treatment arm developed treatment-emergent resistance. In addition, there were no renal adverse events leading to discontinuations and no cases of proximal renal tubulopathy in either treatment group. The data were presented at the 2018 Conference on Retroviruses and Opportunistic Infections.