Table 2.
Tablet Use and Side Effects in the HIV Prevention Trials Network (HPTN) 067 Study by Site and Arm, Bangkok, Thailand (n = 178) and Harlem, New York (n = 179)
| Characteristic | Bangkok | Harlem | ||||||
|---|---|---|---|---|---|---|---|---|
| Daily | Time-Driven | Event-Driven | P Value | Daily | Time-Driven | Event-Driven | P Value | |
| No. | 60 | 59 | 59 | … | 59 | 60 | 60 | … |
| Tablets required for full coverage | 1746 | 1573 | 1268 | .90 | 1244 | 1390 | 1582 | .55 |
| Total tablets used (% of daily) | 8285 | 3713 (44.8%) | 2157 (26.0%) | <.0001 | 5507 | 2468 (44.8%) | 2356 (42.8%) | <.0001 |
| Tablets recommended (% of daily) | 9420 | 4121 (43.7%) | 1928 (20.5%) | <.0001 | 8222 | 3674 (44.7%) | 2572 (31.3%) | <.0001 |
| Recommended tablets used (% of daily) | 8047 | 3272 (40.7%) | 1255 (15.6%) | <.0001 | 5351 | 1708 (31.9%) | 1063 (19.9%) | <.0001 |
| Adherence (tablets used / recommended) | 85.4% | 79.4% | 65.1% | <.0001 | 65.1% | 46.5% | 41.3% | <.0001 |
| Adherence category (% of group) | <.0001 | <.0001 | ||||||
| 0 | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 1 (1.7%) | ||
| 1%–49% | 4 (6.7%) | 2 (3.4%) | 9 (15.2%) | 20 (33.9%) | 36 (60.0%) | 40 (66.6%) | ||
| 50%–89% | 27 (45.0%) | 43 (72.9%) | 45 (76.3%) | 24 (40.7%) | 22 (36.7%) | 15 (25.0%) | ||
| 90%–99% | 25 (41.6%) | 13 (22.0%) | 2 (3.4%) | 14 (23.7%) | 0 (0%) | 0 (0%) | ||
| 100% | 4 (6.7%) | 1 (1.7%) | 2 (3.4%) | 1 (1.7%) | 0 (0%) | 1 (1.7%) | ||
| No sex | 0 (0%) | 0 (0%) | 1 (1.7%) | 0 (0%) | 0 (0%) | 0 (0%) | ||
| No interview data | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 2 (3.3%) | 3 (5.0%) | ||
| TFV-DP concentration on weeks when sex is reporteda | ||||||||
| Median | 84.3 | 36.9 | 29.9 | <.0001 | 316.0 | 122.5 | 84.9 | .0064 |
| IQR | (64.3–127.0) | (22.9–83.0) | (18.8–46.4) | (0–942.0) | (41.8–409.0) | (0–202.0) | ||
| Visits with TFV-DP concentrations indicating ≥2 tabletsb taken per week on weeks when sex is reported. | .52 | .014 | ||||||
| Week 10 | 31/31 (100%) | 29/29 (100%) | 30/30 (100%) | 13/23 (56.5%) | 8/23 (34.8%) | 5/27 (18.5%) | ||
| Week 18 | 28/29 (96.6%) | 30/30 (100%) | 24/26 (92.3%) | 11/27 (40.7%) | 10/27 (37.0%) | 3/21 (14.3%) | ||
| Week 30 | 22/23 (95.7%) | 18/19 (94.7%) | 13/14 (92.9%) | 9/18 (50.0%) | 3/18 (16.7%) | 3/18 (16.7%) | ||
| Overall | 81/83 (97.6%) | 77/78 (98.7%) | 67/70 (95.7%) | 33/68 (48.5%) | 21/68 (30.9%) | 11/66 (16.7%) | ||
| Neurologic side effect, % of visits | 14.2% | 14.3% | 13.3% | .94 | 6.1% | 3.3% | 4.5% | .32 |
| Gastrointestinal side effects, % of visits | 13.1% | 8.5% | 10.5% | .38 | 8.0% | 5.8% | 7.1% | .75 |
Data are presented as No. (%) unless otherwise indicated.
Abbreviations: IQR, interquartile range; TFV-DP, tenofovir diphosphate.
aTFV-DP in peripheral blood mononuclear cells (PBMCs) was analyzed for Bangkok, and dried blood spots (DBSs) for Harlem.
bFor Bangkok, TFV-DP in PBMCs >5.2 fmol/106 cells is considered as participants taken ≥2 tablets per week; For Harlem, TFV-DP in DBSs ≥326 fmol/punch is considered as participants taken ≥2 tablets per week.