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. Author manuscript; available in PMC: 2019 Jan 1.
Published in final edited form as: J Viral Hepat. 2017 Aug 14;25(1):37–46. doi: 10.1111/jvh.12761

Table 2.

Study outcomes by treatment arm

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