Table 1.
Baseline demographics and risk factors in the safety analysis population
| Emtricitabine and tenofovir alafenamide group (n=2694) | Emtricitabine and tenofovir disoproxil fumarate group (n=2693) | ||
|---|---|---|---|
| Demographics | |||
| Age, years | 34 (28–43) | 34 (28–44) | |
| Race* | |||
| White | 2264 (84%) | 2247 (84%) | |
| Black† | 240 (9%) | 234 (9%) | |
| Asian | 113 (4%) | 120 (4%) | |
| Other | 74 (3%) | 87 (3%) | |
| Hispanic or Latinx ethnicity | 635 (24%) | 683 (25%) | |
| Gender or sexual orientation | |||
| Transgender women who have sex with men | 45 (2%) | 29 (1%) | |
| Cisgender men who have sex with men | 2649 (98%) | 2664 (99%) | |
| Sexual orientation | |||
| Gay | 2461 (92%) | 2434 (91%) | |
| Straight | 21 (1%) | 16 (1%) | |
| Bisexual | 171 (6%) | 214 (8%) | |
| Other | 23 (1%) | 13 (<1%) | |
| Region | |||
| USA | 1591 (59%) | 1629 (60%) | |
| EU | 912 (34%) | 902 (33%) | |
| Canada | 191 (7%) | 162 (6%) | |
| Median body-mass index, kg/m2 | 25 (23–29) | 25 (23–28) | |
| Sexually transmitted infections by laboratory test at baseline visit | |||
| Rectal gonorrhoea | 123/2668 (5%) | 113/2669 (4%) | |
| Rectal chlamydia | 199/2669 (7%) | 189/2670 (7%) | |
| Syphilis | 7 (<1%) | 4 (<1%) | |
| Self-reported HIV risk factors | |||
| Two or more of receptive condomless anal sex partners in the past 12 weeks‡ | 1616/2602 (62%) | 1569/2597 (60%) | |
| History of rectal gonorrhoea in the past 24 weeks | 274 (10%) | 262 (10%) | |
| History of rectal chlamydia in the past 24 weeks | 342 (13%) | 333 (12%) | |
| History of syphilis in the past 24 weeks | 230 (9%) | 263 (10%) | |
| Recreational drug use in the past 12 weeks‡ | 1785/2680 (67%) | 1786/2677 (67%) | |
| Binge drinkingठ| 618/2657 (23%) | 599/2680 (22%) | |
| Taking emtricitabine and tenofovir disoproxil fumarate for pre-exposure prophylaxis at baseline | 465 (17%) | 440 (16%) | |
Data are median (IQR), n (%), or n/N (%).
*
Denominator for race excludes eight participants with missing race data (three in the emtricitabine and tenofovir alafenamide group and five in the emtricitabine and tenofovir disoproxil fumarate group), as collection was not permitted.
†
Includes individuals who were mixed Black race.
‡
As reported by use of a computer-assisted self interview.
§
Defined as the consumption of six or more drinks on one or more occasion occurring at least once per month.