Table 1.
Baseline Demographic and Clinical Characteristics
| Characteristic | B/F/TAF (n = 284) | DTG + F/TAF (n = 281) |
|---|---|---|
| Age, y, median ( range) | 51 (22–79) | 50 (20–79) |
| Women | 39 (14%) | 41 (15%) |
| Race | ||
| White | 200 (71%) | 199 (72%) |
| Black | 68 (24%) | 61 (22%) |
| Other | 9 (3%) | 13 (5%) |
| Asian | 3 (1%) | 3 (1%) |
| Native Hawaiian or Pacific Islander | 2 (1%) | 1 (<1%) |
| Ethnicity | ||
| Hispanic or Latino | 61 (22%) | 49 (18%) |
| Region | ||
| United States | 216 (76%) | 215 (77%) |
| Ex–United States | 68 (24%) | 66 (23%) |
| HIV disease status | ||
| Asymptomatic | 240 (85%) | 227 (81%) |
| Symptomatic | 14 (5%) | 21 (7%) |
| AIDS | 30 (11%) | 33 (12%) |
| HIV risk factora | ||
| Homosexual sex | 189 (67%) | 191 (68%) |
| Heterosexual sex | 75 (26%) | 73 (26%) |
| Intravenous drug use | 15 (5%) | 15 (5%) |
| Unknown | 12 (4%) | 8 (3%) |
| Other | 2 (1%) | 1 (<1%) |
| Vertical transmission | 2 (1%) | 0 |
| Transfusion | 0 | 1 (<1%) |
| Number with HIV type 1 RNA | ||
| <50 copies/mL | 276 (97%) | 275 (98%) |
| ≥50 copies/mL | 8 (3%) | 6 (2%) |
| CD4 count, cells/μL, median (IQR) | 659 (486–885) | 642 (462–791) |
| CD4 cell count, cells/μL | ||
| <200 | 6 (2%) | 7 (2%) |
| 200–499 | 71 (25%) | 78 (28%) |
| ≥500 | 207 (73%) | 196 (70%) |
| CD4%, median (IQR) | 35 (29–41) | 34 (27–41) |
| Creatinine clearance by Cockcroft-Gault formula, mL/minute , median (IQR) | 97 (79–114) | 100 (83–124) |
| HIV/HBV coinfected | 13 (5%) | 7 (2%) |
| HIV/HCV coinfected | 1 (<1%) | 5 (2%) |
| BMI, kg/m2 , median (IQR) | 26 (24–31) | 27 (24–31) |
| NRTI resistance stratumb (by category) | ||
| 1. K65R/E/N or ≥3 TAMs | 16 (6%) | 14 (5%) |
| 2. Any other pattern of NRTI mutation | 55 (19%) | 53 (19%) |
| 3. No NRTI mutation | 213 (75%) | 214 (76%) |
| NRTI backbone stratum | ||
| F/TAF | 194 (68%) | 195 (69%) |
Data are presented as no. (%) unless otherwise indicated.
Abbreviations: B/F/TAF, bictegravir/emtricitabine/tenofovir alafenamide; BMI, body mass index; DTG + F/TAF, dolutegravir plus emtricitabine/tenofovir alafenamide; HBV, hepatitis B virus; HCV, hepatitis C virus; HIV, human immunodeficiency virus; IQR, interquartile range; NRTI, nucleoside reverse transcriptase inhibitor; TAM, thymidine analogue mutation.
aA participant may fit >1 HIV risk factor category; therefore, percentages may add to >100%.
bCategory 1 included high-level NRTI resistance defined as K65R/E/N or ≥3 TAMs, 1 of which was M41L or L210W (TAMs [M41L, D67N, K70R, L210W, T215F/Y, and K219Q/E/R/N]) or T69 insertions; category 2 included any other pattern of NRTI resistance including ≤2 TAMs, T69D, K70E/G/M/Q/S/T, L74I/V, V75A/S/M/T Y115F, Q151M, and M184V/I; category 3 was no NRTI resistance mutations. For participants who met criteria for >1 category, stratification was prioritized by category 1, then 2, then 3. Participants with suspected resistance were categorized based on the investigator’s review of their treatment history.