Table 3.
Treatment Differences in Virologic Outcomes at Week 48, by Subgroup
| Characteristic | B/F/TAF (n = 284), No. (%) | DTG + F/TAF (n = 281), No. (%) | Difference in Percentages (95% CI) |
|---|---|---|---|
| HIV-1 RNA <50 copies per mL | |||
| Overall | 265 (93.3%) | 256 (91.1%) | 2.2% (−2.3% to 6.8%) |
| Age | |||
| <50 y | 118/127 (92.9%) | 120/130 (92.3%) | 0.6% (−6.3% to 7.6%) |
| ≥50 y | 147/157 (93.6%) | 136/151 (90.1%) | 3.6% (−2.7% to 10.3%) |
| Sex | |||
| Male | 230/245 (93.9%) | 220/240 (91.7%) | 2.2% (−2.5% to 7.1%) |
| Female | 35/39 (89.7%) | 36/41 (87.8%) | 1.9% (−13.6% to 18.1%) |
| Race | |||
| Black | 62/68 (91.2%) | 56/61 (91.8%) | −0.6% (−11.3% to 10.3%) |
| Not black | 201/214 (93.9%) | 197/217 (90.8%) | 3.1% (−2.0% to 8.5%) |
| Region | |||
| United States | 202/216 (93.5%) | 197/215 (91.6%) | 1.9% (−3.3% to 7.1%) |
| Ex–United States | 63/68 (92.6%) | 59/66 (89.4%) | 3.3% (−7.3% to 14.5%) |
| Study drug adherence | |||
| <95% | 51/59 (86.4%) | 60/66 (90.9%) | −4.5% (−17.0% to 7.2%) |
| ≥95% | 214/225 (95.1%) | 196/213 (92.0%) | 3.1% (−1.6% to 8.1%) |
| Baseline NRTI resistance | |||
| No NRTI mutation | 199/213 (93.4%) | 191/214 (89.3%) | 4.2% (−1.3% to 9.9%) |
| Any NRTI mutation | 66/71 (93.0%) | 65/67 (97.0%) | −4.1% (−13.2% to 4.5%) |
| Baseline M184V/I resistance | |||
| No M184V/I | 223/237 (94.1%) | 224/247 (90.7%) | 3.4% (−1.5% to 8.4%) |
| M184V/I | 42//47 (89.4%) | 32/34 (94.1%) | −4.8% (−18.2% to 9.9%) |
| HIV-1 RNA <20 copies per mL | |||
| Overall | 257 (90.5%) | 241 (85.8%) | 4.7% (−.7% to 10.3%) |
| Baseline NRTI resistance | |||
| No NRTI mutation | 194/213 (91.1%) | 182/214 (85.0%) | 6.0% (−.2% to 12.4%) |
| Any NRTI mutation | 63/71 (88.7%) | 59/67 (88.1%) | 0.7% (−10.7% to 12.3%) |
| Baseline M184V/I mutation | |||
| No M184V/I | 216/237 (91.1%) | 212/247 (85.8%) | 5.3% (−.5% to 11.2%) |
| M184V/I | 41/47 (87.2%) | 29/34 (85.3%) | 1.9% (−13.8% to 19.6%) |
| Undetectable HIV-1 RNA | |||
| Overall | 182 (64.1%) | 170 (60.5%) | 3.6% (−4.5% to 11.6%) |
| Baseline NRTI resistance | |||
| No NRTI mutation | 133/213 (62.4%) | 129/214 (60.3%) | 2.2% (−7.1% to 11.4%) |
| Any NRTI mutation | 49/71 (69.0%) | 41/67 (61.2%) | 7.8% (−8.4% to 23.8%) |
| Baseline M184V/I mutation | |||
| No M184V/I | 153/237 (64.6%) | 153/247 (61.9%) | 2.6% (−6.0% to 11.3%) |
| M184V/I | 29/47 (61.7%) | 17/34 (50.0%) | 11.7% (−10.5% to 33.6%) |
Virology outcomes are based on snapshot algorithm. For race, subjects who reported “not permitted” were excluded from the percentage. Study drug adherence subgroup analyses are based on the adherence up to week 48 visit for active study drug; only subjects who returned at least 1 bottle and had calculable drug adherence were included.
Abbreviations: 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; NRTI, nucleoside reverse transcriptase inhibitor.