ctive-controlled studies, GS-US-380-1489 (n=629) and GS-US-380-1490 (n=645).
The efficacy and safety of Biktarvy in virologically-suppressed HIV-1 infected adults are based on 48-week data from a randomized, double-blind, active-controlled study, GS-US-380-1844 (n=563); and a randomized, open label, active-controlled study, GS-US-380-1878 (n=577).
HIV-1 infected, treatment-naïve patients
In Study GS-US-380-1489, patients were randomized in a 1:1 ratio to receive either B/F/TAF (n=314) or abacavir/dolutegravir/lamivudine (600/50/300 mg) (n=315) once daily. In Study GS-US-380-1490, patients were randomized in a 1:1 ratio to receive either B/F/TAF (n=320) or dolutegravir + emtricitabine/tenofovir alafenamide (50+200/25 mg) (n=325) once daily.
In Studies GS-US-380-1489 and GS-US-380-1490, the mean age was 35 years (range 18-77), 89% were male, 58% were White, 33% were Black, and 3% were Asian. 24% percent of patients identified as Hispanic/Latino. The preva lence of different subtypes was comparable across all three treatment groups, with subtype B predominant in both groups; 11% were non-B subtypes. The mean baseline plasma HIV-1 RNA was 4.4 log10 copies/mL (range 1.3-6.6). The mean baseline CD4+ cell count was 460 cells/mm3 (range 0-1636) and 11% had CD4+ cell counts less than 200 cells/mm3. Eighteen percent of patients had baseline viral loads greater than 100,000 copies/mL. In both studies, patients were stratified by baseline HIV-1 RNA (less than or equal to 100,000 copies/mL, greater than 100,000 copies/mL to less than or equal to 400,000 copies/mL, or greater than 400,000 copies/mL), by CD4 count (less than 50 cells/μL, 50-199 cells/μL, or greater than or equal to 200 cells/μL), and by region (US or ex-US).
Treatment outcomes of Studies GS-US-380-1489 and GS-US-380-1490 through Week 48 are presented in Table 3.
Table 3: Pooled Virologic Outcomes of Studies GS-US-380-1489 and GS-US-380-1490 at Week 48 in Treatment-Naïve Patientsa
B/F/TAF
(n=634)b
ABC/DTG/3TC
(n=315)c
DTG + F/TAF
(n=325)d
HIV-1 RNA < 50 copies/mL
91%
93%
93%
Treatment Difference (95% CI) B/F/TAF vs. Comparator
-
-2.1%
(-5.9% to 1.6%)
-1.9%
(-5.6% to 1.8%)
HIV-1 RNA ≥ 50 copies/mLe
3%
3%
1%
No Virologic Data at Week 48 Window
6%
4%
6%
Discontinued Study Drug Due to AE or Deathf
<1%
1%
1%
Discontinued Study Drug Due to Other Reasons and Last Available HIV-1 RNA < 50 copies/mLg
4%
3%
4%
Missing Data During Window but on Study Drug
2%
<1%
1%
Proportion (%) of Patients with HIV-1 RNA < 50 copies/mL by Subgrouph
By Baseline Viral Load
≤ 100,000 copies/mL
> 100,000 copies/mL
92%
87%
94%
90%
93%
94%
By Baseline CD4+ Cell Count
< 200 cells/mm3
≥ 200 cells/mm3
90%
91%
81%
94%
100%
92%
HIV-1 RNA < 20 copies/mL
85%
87%
87%
ABC=abacavir
DTG=dolutegravir
3TC=lamivudine
F/TAF=emtricitabine/tenofovir alafenamide
a Week 48 window was between Day 295 and 378 (inclusive).
b Pooled from Study GS-US-380-1489 (n=314) and Study GS-US-380-1490 (n=320).
c Study GS-US-380-1489
d Study GS-US-380-1490
e Includes patients who had ≥ 50 copies/mL in the Week 48 window; patients who discontinued early due to lack or loss of efficacy; patients who discontinued for reasons other than an adverse event (AE), death or lack or loss of efficacy and at the time of discontinuation had a viral value of ≥ 50 copies/mL.
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