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1 (1:1) to receive oral fixed-dose combination bictegravir 50 mg, emtricitabine 200 mg, and tenofovir a
2 block size of four), to receive coformulated bictegravir 50 mg, emtricitabine 200 mg, and tenofovir a
3                                              Bictegravir, a novel, once-daily, unboosted INSTI, showe
4                            Administration of bictegravir, a novel, potent, once-daily INSTI designed
5 study comparing initial HIV-1 treatment with bictegravir-a novel INSTI with a high in-vitro barrier t
6 e aimed to assess the efficacy and safety of bictegravir coformulated with emtricitabine and tenofovi
7 ned 631 participants to receive coformulated bictegravir, emtricitabine, and tenofovir alafenamide (n
8    INTERPRETATION: At 48 weeks, coformulated bictegravir, emtricitabine, and tenofovir alafenamide ac
9                         Because coformulated bictegravir, emtricitabine, and tenofovir alafenamide do
10 ere randomly assigned to treatment (327 with bictegravir, emtricitabine, and tenofovir alafenamide fi
11 d in 92.4% of patients (n=290 of 314) in the bictegravir, emtricitabine, and tenofovir alafenamide gr
12 h occurred less frequently in patients given bictegravir, emtricitabine, and tenofovir alafenamide th
13  related to study drug were less common with bictegravir, emtricitabine, and tenofovir alafenamide th
14 6; p=0.78), demonstrating non-inferiority of bictegravir, emtricitabine, and tenofovir alafenamide to
15                                              Bictegravir, emtricitabine, and tenofovir alafenamide wa
16                The fixed-dose combination of bictegravir, emtricitabine, and tenofovir alafenamide wa
17  due to adverse events (5 [2%] of 320 in the bictegravir group and 1 [<1%] 325 in the dolutegravir gr
18 eved in 286 (89%) of 320 participants in the bictegravir group and 302 (93%) of 325 in the dolutegrav
19          At week 24, 63 (96.9%) of 65 in the bictegravir group had HIV-1 RNA loads of less than 50 co
20 lated adverse events were less common in the bictegravir group than in the dolutegravir group (57 [18
21 enofovir alafenamide fixed-dose combination [bictegravir group] and 330 with dolutegravir plus emtric
22                                              Bictegravir is a novel, potent INSTI with a high in-vitr
23 pants (2:1) to receive oral once-daily 75 mg bictegravir or 50 mg dolutegravir with matching placebo
24 ported by 55 (85%) of 65 participants in the bictegravir plus emtricitabine and tenofovir alafenamide
25                              INTERPRETATION: Bictegravir plus emtricitabine and tenofovir alafenamide
26 ing and giving study drug to 98 (65 received bictegravir plus emtricitabine and tenofovir alafenamide
27                       One participant taking bictegravir plus emtricitabine and tenofovir alafenamide
28            320 participants who received the bictegravir regimen and 325 participants who received th
29 1.0, p=0.12), showing non-inferiority of the bictegravir regimen to the dolutegravir regimen.
30 t 48 weeks, virological suppression with the bictegravir regimen was achieved and was non-inferior to
31 se results, we did a phase 2 trial comparing bictegravir with dolutegravir.

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