Table 3.
Participant adherence at weeks 12, 24, and 48
|
Supplemental dolutegravir arm (n=53) |
Placebo arm (n=55) |
||||
|---|---|---|---|---|---|
| Female (n=19) | Male (n=34) | Female (n=19) | Male (n=36) | ||
| Week 12 | |||||
| n | 19 | 33 | 19 | 34 | |
| Tenofovir diphosphate, fmol/punch | 1222 (810–1846) | 1333 (756–1863) | 1268 (708–2165) | 1239 (871–1959) | |
| Adherence category, fmol/punch | |||||
| <350 | 1 (5%) | 2 (6%) | 0 | 1 (3%) | |
| 350–700 | 1 (5%) | 6 (18%) | 4 (21%) | 5 (15%) | |
| 701–1250 | 8 (42%) | 8 (24%) | 5 (26%) | 11 (32%) | |
| >1250 | 9 (47%) | 17 (52%) | 10 (53%) | 17 (50%) | |
| Week 24 | |||||
| n | 18 | 33 | 17 | 35 | |
| Tenofovir diphosphate (fmol/punch) | 1281 (1113–1623) | 1491 (858–2124) | 1449 (1003–1708) | 1479 (857–1997) | |
| Adherence category, fmol/punch | |||||
| <350 | 0 | 2 (6%) | 1 (6%) | 1 (3%) | |
| 350–700 | 0 | 2 (6%) | 2 (12%) | 5 (14%) | |
| 701–1250 | 9 (50%) | 11 (33%) | 3 (18%) | 7 (20%) | |
| >1250 | 9 (50%) | 18 (55%) | 11 (65%) | 22 (63%) | |
| Week 48 | |||||
| n | 16 | 31 | 16 | 30 | |
| Tenofovir diphosphate (fmol/punch) | 1424 (1039–2514) | 1380 (635–2625) | 1502 (920–2658) | 1573 (1105–1981) | |
| Adherence category, fmol/punch | |||||
| <350 | 1 (6%) | 5 (16%) | 3 (19%) | 3 (10%) | |
| 350–700 | 1 (6%) | 4 (13%) | 0 | 2 (7%) | |
| 701–1250 | 5 (31%) | 4 (13%) | 4 (25%) | 5 (17%) | |
| >1250 | 9 (56%) | 18 (58%) | 9 (56%) | 20 (67%) | |
Data are median (IQR). Adherence measured as tenofovir diphosphate concentrations in dried blood spots and presented as categories of presumed doses of medication taken per week. Adherence categories, <350 fmol/punch (equivalent in men: <1·2 doses per week and women: <0·6 doses per week), 350–700 fmol/punch (men: 1·2–3·2 doses per week and women: 0·6–2·0 doses per week), 701–1250 fmol/punch (men: 3·2–6·0 doses per week and women: 2·0–5·3 doses per week), and >1250 fmol/punch (men: >6·0 doses per week and women: >5·3 doses per week).