Table 2.
Arm 1 (N=25) 12 weeks SOF+PR |
Arm 2 (N=25) 24 weeks SOF+R |
p-value | |||
---|---|---|---|---|---|
Primary outcome | |||||
Treatment completion, n(%) | 22 | 88.0 | 22 | 88.0 | >0.99 |
Secondary outcomes | |||||
Sustained virologic response*, n(%) | 22 | 88.0 | 15 | 60.0 | 0.05 |
Median number of serious adverse events, IQR | 0 | 0 | |||
Median change in insulin resistance (HOMA-IR), IQR | 1.2 | -0.1, 9.1 | 0.1 | -1.3, 6.1 | 0.30 |
Exploratory outcomes | |||||
Percentage completed doses, n(%) | |||||
0–30% | 3 | 12.0 | 3 | 12.0 | |
75–90% | 3 | 12.0 | 2 | 8.0 | |
>90–95% | 2 | 8.0 | 4 | 16.0 | 0.93 |
>95%-100% | 17 | 68.0 | 16 | 64.0 | |
Percentage observed doses received†, n(%) | |||||
70–90% | 0 | 0 | 3 | 12.0 | |
>90–95% | 4 | 16.0 | 3 | 12.0 | 0.31 |
>95–100% | 21 | 84.0 | 19 | 76.0 | |
Median change in self-rated health state VAS †, IQR | 0 | -5, 10 | 5 | -10, 8 | 0.58 |
Intent-to-treat approach (missing=no sustained virologic response)
Out of completed doses
VAS: visual analogue scale with range from 0 (worst health state) to 100 (best health state); †measured using the EQ 5D-3L instrument