ceiving emtricitabine/tenofovir disoproxil fumarate plus atazanavir or darunavir (boosted by either cobicistat or ritonavir).
Treatment outcomes of Studies GS-US-380-1844 and GS-US-380-1878 through Week 48 are presented in Table 4.
Table 4: Virologic Outcomes of Studies GS-US-380-1844 and GS-US-380-1878 at Week 48a
Study GS-US-380-1844
Study GS-US-380-1878
B/F/TAF(n=282)
ABC/DTG/3TC (n=281)
B/F/TAF (n=290)
Baseline ATV- or DRV-based regimen (n=287)
HIV-1 RNA < 50 copies/mL
94%
95%
92%
89%
Treatment Difference (95% CI)
-1.4% (-5.5% to 2.6%)
3.2% (-1.6% to 8.2%)
HIV-1 RNA ≥ 50 copies/mLb
1%
<1%
2%
2%
Treatment Difference (95% CI)
0.7% (-1.0% to 2.8%)
0.0% (-2.5% to 2.5%)
No Virologic Data at Week 48 Window
5%
5%
6%
9%
Discontinued Study Drug Due to AE or Death and Last Available HIV-1 RNA < 50 copies/mL
2%
1%
1%
1%
Discontinued Study Drug Due to Other Reasons and Last Available HIV-1 RNA < 50 copies/mLc
2%
3%
3%
7%
Missing Data During Window but on Study Drug
2%
1%
2%
2%
ABC= abacavir
ATV=atazanavir
DRV=darunavir
DTG=dolutegravir
3TC=lamivudine
a Week 48 window was between Day 295 and 378 (inclusive)
b 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 lack or loss of efficacy and at the time of discontinuation had a viral value of ≥ 50 copies/mL.
c 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.
B/F/TAF was non-inferior to the control regimen in both studies. Treatment outcomes between treatment groups were similar across subgroups by age, sex, race, and region.
In GS-US-380-1844, the mean change from baseline in CD4+ count at Week 48 was -31 cells/mm3 in patients who switched to B/F/TAF and 4 cells/mm3 in patients who stayed on abacavir/dolutegravir/lamivudine. In GS-US-380-1878, the mean change from baseline in CD4+ count at Week 48 was 25 cells/mm3 in patients who switched to B/F/TAF and 0 cells/mm3 in patients who stayed on their baseline regimen.
Patients co-infected with HIV and HBV
The number of patients co-infected with HIV and HBV treated with B/F/TAF is limited. In Study GS-US-380-1490, 7 of 8 patients with HIV/HBV co-infection at baseline who were randomized to receive B/F/TAF were HBV suppressed (HBV DNA < 29 IU/mL) and had HIV-1 RNA < 50 copies/mL at Week 48. One patient had missing HBV DNA data at Week 48.
In Study GS-US-380-1878, at Week 48, 100% (8/8) of the patients co-infected with HIV/HBV at baseline in the B/F/TAF arm maintained HBV DNA < 29 IU/mL (missing = excluded analysis) and HIV RNA < 50 copies/mL.
Paediatric population
The European Medicines Agency has deferred the obligation to submit the results of studies with B/F/TAF in one or more subsets of the paediatric population in the treatment of human HIV-1 infection (see section 4.2 for information on paediatric use).
5.2 Pharmacokinetic properties
Absorption
Bictegravir is absorbed following oral administration with peak plasma concentrations occurring at 2.0-4.0 hours after administration of B/F/TAF. Relative to fasting conditions, the administration of B/F/TAF with either a moderate fat (~600 kcal, 27% fat) or high fat meal (~800 kcal, 50% fat) resulted in an increase in bictegravir AUC (24%). This modest change is not considered |
