Parameter | Current ARV treatmenta (N = 27) | Screening placebo (N = 27) | D/C/F/TAF placebo (N = 27) | Darunavir/cobicistat placebo (N = 27) |
---|---|---|---|---|
How difficult/easy to swallow tablet, n (% to cumulative %) | ||||
Very easy | 18 (66.7% to 66.7%) | 12 (44.4% to 44.4%) | 17 (63.0% to 63.0%) | 16 (59.3% to 59.3%) |
Moderately easy | 5 (18.5% to 85.2%) | 6 (22.2% to 66.7%) | 3 (11.1% to 74.1%) | 4 (14.8% to 74.1%) |
Slightly easy | 2 (7.4% to 92.6%) | 2 (7.4% to 74.1%) | 4 (14.8% to 88.9%) | 5 (18.5% to 92.6%) |
Neither difficult nor easy | 2 (7.4% to 100%) | 1 (3.7% to 77.8%) | 1 (3.7% to 92.6%) | 2 (7.4% to 100%) |
Slightly difficult | 0 | 4 (14.8% to 92.6%) | 1 (3.7% to 96.3%) | 0 |
Moderately difficult | 0 | 0 | 0 | 0 |
Very difficult | 0 | 2 (7.4% to 100%) | 1 (3.7% to 100%) | 0 |
Swallowing acceptability, n (%) (95% CI) | ||||
Easyb | 27 (100%) | 21 (77.8%) | 25 (92.6%) | 27 (100%) |
(87.2% to 100%) | (57.7% to 91.4%) | (75.7% to 99.1%) | (87.2% to 100%) | |
Difficultc | 0 (0.0%) | 6 (22.2%) | 2 (7.4%) | 0 (0.0%) |
(0.0% to 12.8%) | (8.6% to 42.3%) | (0.9% to 24.3%) | (0.0% to 12.8%) | |
Swallowing acceptability should tablet be taken once daily over a longer period, n (% to cumulative %) | ||||
Good to take | 14 (51.9% to 51.9%) | 14 (51.9% to 51.9%) | 15 (55.6% to 55.6%) | |
Acceptable | 9 (33.3% to 85.2%) | 11 (40.7% to 92.6%) | 12 (44.4% to 100%) | |
Not acceptable | 4 (14.8% to 100%) | 2 (7.4% to 100%) | 0 |
aall patients received ≥1 FDC in their current antiretroviral regimen, most commonly elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (12 [44.4%] patients), rilpivirine/emtricitabine/tenofovir disoproxil fumarate, dolutegravir/abacavir/lamivudine and abacavir/lamivudine (4[14.8%] patients each).
bEasy = ‘Very easy’, ‘Moderately easy’, ‘Slightly easy’, ‘Neither difficult nor easy’.
cDifficult = ‘Slightly difficult’, ‘Moderately difficult’, ‘Very difficult’.
95% CI – Clopper‐Pearson exact confidence interval for binomial proportion.