f Includes patients who discontinued due to AE or death at any time point from Day 1 through the time window if this resulted in no virologic data on treatment during the specified window.
g Includes patients who discontinued for reasons other than an AE, death or lack or loss of efficacy, e.g. withdrew consent, loss to follow-up, etc.
h Patients who had ≥ 50 copies/mL in the Week 48 window included patients who discontinued early due to lack or loss of efficacy (n=0), and patients who discontinued for reasons other than an AE, death or lack or loss of efficacy (B/F/TAF n=12; ABC/DTG/3TC n=2; DTG+F/TAF n=3), and at the time of discontinuation had a viral value of ≥ 50 copies/mL.
B/F/TAF was non-inferior in achieving HIV-1 RNA < 50 copies/mL at Week 48 when compared to abacavir/dolutegravir/lamivudine and dolutegravir+emtricitabine/tenofovir alafenamide, respectively. Treatment outcomes were similar across subgroups by age, sex, race, baseline viral load, baseline CD4+ cell count, and region.
In Studies GS-US-380-1489 and GS-US-380-1490, the mean increase from baseline in CD4+ count at Week 48 was 207, 229, and 201 cells/mm3 in the pooled B/F/TAF, abacavir/dolutegravir/lamivudine, and dolutegravir+emtricitabine/tenofovir alafenamide groups, respectively.
HIV-1 infected, virologically suppressed patients
In Study GS-US-380-1844, the efficacy and safety of switching from a regimen of dolutegravir+abacavir/lamivudine or abacavir/dolutegravir/lamivudine to B/F/TAF were eva luated in a randomized, double-blind study of virologically-suppressed (HIV-1 RNA < 50 copies/mL) HIV-1 infected adults (n=563). Patients must have been stably suppressed (HIV-1 RNA < 50 copies/mL) on their baseline regimen for at least 3 months prior to study entry. Patients were randomized in a 1:1 ratio to either switch to B/F/TAF at baseline (n=282), or stay on their baseline antiretroviral regimen (n=281). Patients had a mean age of 45 years (range 20-71), 89% were male, 73% were White, and 22% were Black. 17% of patients identified as Hispanic/Latino. The preva lence of different HIV-1 subtypes was comparable between treatment groups, with subtype B predominant in both groups; 5% were non-B subtypes. The mean baseline CD4+ cell count was 723 cells/mm3 (range 124-2444).
In Study GS-US-380-1878, the efficacy and safety of switching from either abacavir/lamivudine or emtricitabine/tenofovir disoproxil fumarate (200/300 mg) plus atazanavir or darunavir (boosted by either cobicistat or ritonavir) to B/F/TAF were eva luated in a randomized, open-label study of virologically-suppressed HIV-1 infected adults (n=577). Patients must have been stably suppressed on their baseline regimen for at least 6 months and must not have been previously treated with any INSTI. Patients were randomized in a 1:1 ratio to either switch to B/F/TAF (n=290), or stay on their baseline antiretroviral regimen (n=287). Patients had a mean age of 46 years (range 20-79), 83% were male, 66% were White, and 26% were Black. 19% of patients identified as Hispanic/Latino. The mean baseline CD4+ cell count was 663 cells/mm3 (range 62-2582). The preva lence of different subtypes was comparable across treatment groups, with subtype B predominant in both groups; 11% were non-B subtypes. Patients were stratified by prior treatment regimen. At screening, 15% of patients were receiving abacavir/lamivudine plus atazanavir or darunavir (boosted by either cobicistat or ritonavir) and 85% of patients were re |
