Table 2.
Virologic Outcomes at Week 48
| Outcome | B/F/TAF (n = 284) | DTG + F/TAF (n = 281) | B/F/TAF vs DTG + F/TAF |
|---|---|---|---|
| Difference in Percentages (95.001% CI)a | |||
| HIV-1 RNA <50 copies/mL | 265 (93.3%) | 256 (91.1%) | 2.2% (−2.3% to 6.8%) |
| HIV-1 RNA ≥50 copies/mL | 1 (0.4%) | 3 (1.1%) | −0.7% (−2.8% to 1.0%) |
| HIV-1 RNA ≥50 copies/mL | 1 (0.4%) | 1 (0.4%) | … |
| Discontinued due to lack of efficacy | 0 | 0 | … |
| Discontinued study drug due to AE/death and last available HIV-1 RNA ≥50 copies/mL | 0 | 0 | … |
| Discontinued due to other reasonsb and last available HIV-1 RNA ≥50 copies/mL | 0 | 2 (0.7%) | … |
| No virologic data | 18 (6.3%) | 22 (7.8%) | … |
| Discontinued due to AE/death and last available HIV-1 RNA <50 copies/mL | 6 (2.1%) | 6 (2.1%) | … |
| Discontinued due to other reasonsb and last available HIV-1 RNA <50 copies/mL | 12 (4.2%) | 15 (5.3%) | … |
| Missing data but on study drug | 0 | 1 (0.4%) | … |
| HIV-1 RNA <50 copies/mL by per-protocol snapshot analysis | 259/259 (100%) | 237/237 (100%) | NA |
| HIV-1 RNA <50 copies/mL by missing = failurec | 266/284 (93.7%) | 260/281 (92.5%) | 1.1% (−3.2% to 5.5%) |
| HIV-1 RNA <50 copies/mL by missing = excludedc | 266/269 (98.9%) | 260/261 (99.6%) | −0.7% (−2.9% to 1.2%) |
| HIV-1 RNA <20 copies/mL | 257/284 (90.5%) | 241/281 (85.8%) | 4.7% (−.7% to 10.3%) |
Data are presented as no. (%) unless otherwise indicated. Virology outcomes are based on snapshot algorithm unless otherwise specified. The week 48 window is between days 295 and 378 (inclusive). Per-protocol analysis excluded patients in the full analysis set who were off study drug at week 48 or had low adherence, that is, adherence ≤2.5th percentile among those in the study.
Abbreviations: AE, adverse event; B/F/TAF, bictegravir/emtricitabine/tenofovir alafenamide; CI, confidence interval; DTG + F/TAF, dolutegravir plus emtricitabine/tenofovir alafenamide; HIV-1, human immunodeficiency virus type 1; NA, not applicable.
aThe differences in percentages of subjects between treatment groups and their 95.001% CIs (for HIV-1 RNA <50 copies/mL or HIV-1 RNA ≥50 by US Food and Drug Administration snapshot algorithm), or otherwise 95% CI, were calculated based on an unconditional exact method using 2 inverted 1-sided tests.
bOther reasons include subjects who discontinued study drug due to the investigator’s discretion, subject decision, loss to follow-up, noncompliance with study drug, protocol violation, pregnancy, and study terminated by sponsor.
cDifferences in percentages, and 95% CI, were based on a dichotomized response: HIV-1 RNA <50 copies/mL vs HIV-1 RNA ≥50 copies/mL or missing for the missing = failure approach and HIV-1 RNA <50 copies/mL vs HIV-1 RNA ≥50 copies/mL for the missing = excluded approach.