Table 1. Baseline Characteristics During the 12-Month Period Prior to the Index Date.
| Cohort | Standardized Difference (P Valuea) vs TAF 25 mg | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| TAF 25 mg (n=710) | TAF 10 mg (n=303) | TDF (n=219) | Non-TAF/TDF (n=420) | TAF 10 mg | TDF | Non-TAF/TDF | ||||
| Age at index date (y), mean±SD [median] | 49.7±13.7 [52.0] | 50.2±12.8 [53.0] | 49.9±13.2 [52.0] | 51.3±13.0 [52.0] | 3.6% | (0.61) | 1.5% | (0.85) | 11.6% | (0.06) |
| Age categories (y), n (%) | ||||||||||
| 18-24 | 28 (3.9) | 8 (2.6) | 3 (1.4) | 5 (1.2) | 7.3% | (0.61) | 16.1% | (0.40) | 17.5% | (0.10) |
| 25-34 | 96 (13.5) | 38 (12.5) | 31 (14.2) | 46 (11.0) | 2.9% | 1.8% | 7.8% | |||
| 35-44 | 116 (16.3) | 47 (15.5) | 43 (19.6) | 76 (18.1) | 2.3% | 8.6% | 4.7% | |||
| 45-54 | 173 (24.4) | 78 (25.7) | 48 (21.9) | 110 (26.2) | 3.2% | 5.8% | 4.2% | |||
| 55-64 | 198 (27.9) | 97 (32.0) | 65 (29.7) | 122 (29.0) | 9.0% | 4.0% | 2.6% | |||
| ≥65 | 99 (13.9) | 35 (11.6) | 29 (13.2) | 61 (14.5) | 7.2% | 2.0% | 1.7% | |||
| Female, n (%) | 188 (26.5) | 88 (29.0) | 67 (30.6) | 116 (27.6) | 5.7% | (0.40) | 9.1% | (0.23) | 2.6% | (0.68) |
| Race, n (%) | ||||||||||
| White | 279 (39.3) | 101 (33.3) | 73 (33.3) | 148 (35.2) | 12.4% | (0.14) | 12.4% | (0.59) | 8.4% | (0.43) |
| Black | 203 (28.6) | 106 (35.0) | 66 (30.1) | 125 (29.8) | 13.8% | 3.4% | 2.6% | |||
| Hispanic | 48 (6.8) | 20 (6.6) | 17 (7.8) | 28 (6.7) | 0.6% | 3.9% | 0.4% | |||
| Other | 20 (2.8) | 4 (1.3) | 6 (2.7) | 8 (1.9) | 10.5% | 0.5% | 6.0% | |||
| Unknown | 160 (22.5) | 72 (23.8) | 57 (26.0) | 111 (26.4) | 2.9% | 8.2% | 9.1% | |||
| Insurance plan type, n (%) | ||||||||||
| Insurance plan available | 570 (80.3) | 246 (81.2) | 171 (78.1) | 344 (81.9) | 2.3% | (0.74) | 5.4% | (0.48) | 4.1% | (0.50) |
| Commercial | 395 (69.3) | 170 (69.1) | 110 (64.3) | 241 (70.1) | 0.4% | (0.72) | 10.6% | (0.12) | 1.7% | (0.28) |
| Medicare | 99 (17.4) | 39 (15.9) | 26 (15.2) | 56 (16.3) | 4.1% | 5.9% | 2.9% | |||
| Medicaid | 59 (10.4) | 26 (10.6) | 25 (14.6) | 29 (8.4) | 0.7% | 12.9% | 6.6% | |||
| Other | 17 (3.0) | 11 (4.5) | 10 (5.8) | 18 (5.2) | 7.9% | 14.0% | 11.4% | |||
| US geographic region, n (%) | ||||||||||
| South | 417 (58.7) | 169 (55.8) | 126 (57.5) | 240 (57.1) | 6.0% | (0.81) | 2.4% | (0.95) | 3.2% | (0.85) |
| West | 141 (19.9) | 62 (20.5) | 42 (19.2) | 92 (21.9) | 1.5% | 1.7% | 5.0% | |||
| Northeast | 82 (11.5) | 39 (12.9) | 28 (12.8) | 48 (11.4) | 4.0% | 3.8% | 0.4% | |||
| Midwest | 57 (8.0) | 29 (9.6) | 20 (9.1) | 35 (8.3) | 5.4% | 3.9% | 1.1% | |||
| Unknown | 13 (1.8) | 4 (1.3) | 3 (1.4) | 5 (1.2) | 4.1% | 3.7% | 5.3% | |||
| Year of index date, n (%) | ||||||||||
| 2018 | 215 (30.3) | 144 (47.5) | 95 (43.4) | 162 (38.6) | 35.9% | (<0.001*) | 27.4% | (<0.001*) | 17.5% | (0.004*) |
| 2019 | 495 (69.7) | 159 (52.5) | 124 (56.6) | 258 (61.4) | 35.9% | 27.4% | 17.5% | |||
| Number of mental health-related comorbidities,b mean±SD [median] | 0.5±1.0 [0.0] | 0.3±0.8 [0.0] | 0.4±0.9 [0.0] | 0.5±1.0 [0.0] | 15.8% | (0.02*) | 6.3% | (0.39) | 1.8% | (0.76) |
| Symptomatic HIV and AIDS | 193 (27.2) | 77 (25.4) | 52 (23.7) | 124 (29.5) | 4.0% | (0.56) | 7.9% | (0.31) | 5.2% | (0.40) |
| Quan-CCI,c mean±SD [median] | 1.9±2.9 [0.0] | 1.8±2.9 [0.0] | 1.7±2.9 [0.0] | 2.2±3.2 [0.0] | 2.7% | (0.69) | 5.1% | (0.51) | 10.5% | (0.09) |
| Hypertension | 108 (15.2) | 41 (13.5) | 28 (12.8) | 73 (17.4) | 4.8% | (0.49) | 7.0% | (0.38) | 5.9% | (0.34) |
| Type 2 diabetes mellitus | 38 (5.4) | 25 (8.3) | 12 (5.5) | 25 (6.0) | 11.5% | (0.08) | 0.6% | (0.94) | 2.6% | (0.67) |
| Pre-diabetes | 17 (2.4) | 5 (1.7) | 6 (2.7) | 9 (2.1) | 5.3% | (0.46) | 2.2% | (0.77) | 1.7% | (0.79) |
| Patients with a BMI measurement, n (%) | 703 (99.0) | 299 (98.7) | 217 (99.1) | 411 (97.9) | 3.1% | (0.64) | 0.7% | (0.92) | 9.3% | (0.11) |
| BMI (kg/m2), mean±SD [median] | 28.3±6.2 [27.1] | 28.9±8.9 [27.5] | 28.5±6.1 [27.7] | 28.0±5.8 [27.1] | 8.2% | (0.27) | 2.9% | (0.71) | 4.4% | (0.48) |
| BMI categories (kg/m2), n (%) | ||||||||||
| <25 | 225 (32.0) | 92 (30.8) | 64 (29.5) | 131 (31.9) | 2.7% | (0.92) | 5.4% | (0.79) | 0.3% | (0.56) |
| 25-29 | 247 (35.1) | 104 (34.8) | 82 (37.8) | 157 (38.2) | 0.7% | 5.5% | 6.4% | |||
| 30-34 | 130 (18.5) | 55 (18.4) | 37 (17.1) | 75 (18.2) | 0.3% | 3.8% | 0.6% | |||
| ≥35 | 101 (14.4) | 48 (16.1) | 34 (15.7) | 48 (11.7) | 4.7% | 3.6% | 8.0% | |||
| Patients with a weight measurement, n (%) | 710 (100.0) | 303 (100.0) | 219 (100.0) | 420 (100.0) | — | — | — | — | — | — |
| Weight (kg), mean±SD [median] | 84.2±18.7 [82.1] | 85.1±20.7 [81.9] | 83.8±19.1 [81.9] | 83.6±18.1 [81.7] | 4.7% | (0.50) | 1.9% | (0.81) | 3.1% | (0.62) |
| Index regimen, n (%) | ||||||||||
| PI-based | 27 (3.8) | 39 (12.9) | 9 (4.1) | 7 (1.7) | 33.3% | (<0.001*) | 1.6% | (0.84) | 13.1% | (0.04*) |
| Darunavir-based | 21 (3.0) | 39 (12.9) | 8 (3.7) | 7 (1.7) | 37.4% | (<0.001*) | 3.9% | (0.61) | 8.6% | (0.18) |
| Atazanavir-based | 6 (0.8) | 0 (0.0) | 1 (0.5) | 0 (0.0) | — | — | 4.8% | (0.56) | — | — |
| INSTI-based | 591 (83.2) | 264 (87.1) | 99 (45.2) | 418 (99.5) | 11.0% | (0.12) | 86.4% | (<0.001*) | 60.6% | (<0.001*) |
| Dolutegravir-based | 102 (14.4) | 0 (0.0) | 19 (8.7) | 413 (98.3) | — | — | 17.9% | (0.03*) | 318.0% | (<0.001*) |
| Elvitegravir-based | 0 (0.0) | 264 (87.1) | 52 (23.7) | 0 (0.0) | — | — | — | — | — | — |
| Raltegravir-based | 19 (2.7) | 0 (0.0) | 28 (12.8) | 5 (1.2) | — | — | 38.5% | (<0.001*) | 10.8% | (0.09) |
| Bictegravir-based | 470 (66.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) | — | — | — | — | — | — |
| NNRTI-based | 92 (13.0) | 0 (0.0) | 111 (50.7) | 82 (19.5) | — | — | 88.6% | (<0.001*) | 17.9% | (0.003*) |
| Doravirine-based | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | — | — | — | — | — | — |
| Efavirenz-based | 3 (0.4) | 0 (0.0) | 76 (34.7) | 0 (0.0) | — | — | 100.9% | (<0.001*) | — | — |
| Rilpivirine-based | 89 (12.5) | 0 (0.0) | 35 (16.0) | 82 (19.5) | — | — | 9.9% | (0.19) | 19.1% | (0.002*) |
| Use of at least one medication associated with weight change,d n (%) | 229 (32.3) | 97 (32.0) | 59 (26.9) | 128 (30.5) | 0.5% | (0.94) | 11.7% | (0.14) | 3.8% | (0.54) |
* P value significant at the 5% level.
Abbreviations: BMI, body mass index; CCI, Charlson Comorbidity Index; INSTI, integrase strand transfer inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor; TAF, tenofovir alafenamide; TDF, tenofovir disoproxil fumarate.
aP values were obtained from chi-square test for categorical variables or t test for continuous variables. All chi-square tests used 1 degree of freedom (df), with the following exceptions: categorical age (df=5), race (df=4), insurance plan type (df=3), US geographic region (df=4), and BMI categories (df=3).
b Based on the mental health–related comorbidities listed in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition. See Supplementary Table 2 for the complete list of mental health-related comorbidities.
c Based on the methodology described in Quan et al.13
d See Supplementary Table 3 for the full list of medications associated with weight change.