aFederal University of Rio de Janeiro State– UNIRIO, Brazil
bUniversity Center of Volta Redonda - UNIFOA, Brazil
cPontifical Catholic University of Rio de Janeiro – PUC-RJ, Brazil
dFaculty of Medicine Souza Marques - FTESM, Brazil
Copyright ©2018, Korea Centers for Disease Control and Prevention
This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
Treatment | n | % |
---|---|---|
SOF+DCV | 11 | 20.0 |
SOF+DCV+RBV | 30 | 54.5 |
SOF+SMV | 14 | 25.5 |
Total | 55 | 100.0 |
Scales | Means | ||||
---|---|---|---|---|---|
pre-treatment | week 4 of treatment | end of treatment | 4 weeks post-treatment | p-value | |
SF36: Functional capacity | 59.0 | 57.5 | 61.9 | 67.5 | < 0.001 |
SF36: Physical aspects | 45.0 | 54.5 | 61.4 | 62.7 | 0.011 |
SF36: Pain | 58.6 | 62.3 | 63.6 | 64.7 | 0.223 |
SF36: General health state | 59.5 | 62.9 | 65.6 | 67.4 | 0.035 |
SF36: Vitality | 57.5 | 54.7 | 57.5 | 64.0 | 0.006 |
SF36: Social aspects | 73.6 | 72.7 | 76.8 | 80.7 | 0.054 |
SF36: Emotional aspect | 46.7 | 60.0 | 66.1 | 63.6 | 0.03 |
SF36: Mental health | 71.0 | 68.9 | 68.9 | 74.5 | 0.003 |
CLDQ: Abdominal symptoms | 5.4 | 5.6 | 5.6 | 5.8 | 0.187 |
CLDQ: Fatigue | 4.4 | 4.4 | 4.8 | 5.1 | 0.001 |
CLDQ: Systemic symptoms | 5.1 | 5.2 | 5.1 | 5.5 | < 0.001 |
CLDQ: Activity | 5.0 | 5.0 | 5.2 | 5.4 | 0.632 |
CLDQ: Emotional function | 5.0 | 5.1 | 5.2 | 5.5 | 0.007 |
CLDQ: Worry | 4.8 | 5.3 | 5.4 | 5.5 | < 0.001 |
CLDQ: Total Score | 4.9 | 5.1 | 5.2 | 5.4 | 0.003 |
WPAI: Absenteeism |
3.6 | 9.1 | 9.1 | 4.5 | 0.748 |
WPAI: Presenteeism |
17.5 | 13.5 | 10.0 | 10.6 | 0.168 |
WPAI: Loss of productivity |
15.2 | 11.0 | 7.4 | 9.9 | 0.713 |
WPAI: Decreased activity | 31.3 | 31.6 | 27.3 | 22.9 | 0.178 |
FACIT-F: Physical well-being (PWB) | 21.1 | 20.9 | 22.4 | 23.1 | 0.037 |
FACIT-F: Social/family well-being (SWB) | 19.0 | 18.3 | 19.6 | 18.9 | 0.445 |
FACIT-F: Emotional well-being (EWB) | 17.9 | 18.9 | 19.3 | 19.4 | 0.002 |
FACIT-F: Functional well-being (FWB) | 18.0 | 17.7 | 17.3 | 18.0 | 0.778 |
FACIT-F: Fatigue (FS) | 37.7 | 36.8 | 39.1 | 40.0 | 0.043 |
FACIT-F: TOI (PWB+FWB+FS) | 76.8 | 75.4 | 78.8 | 81.2 | 0.022 |
FACIT-G Total (PWB+SWB+EWB+FWB) | 76.0 | 75.8 | 78.6 | 79.6 | 0.117 |
FACIT-F Total (PWB+SWB+EWB+FWB+FS) | 113.8 | 112.6 | 117.7 | 119.6 | 0.031 |
Pre-treatment scores | Treatment | p-value by Kruskall-Wallis Test | |||||
---|---|---|---|---|---|---|---|
SOF+DCV (n = 11) | SOF+DCV+RBV (n = 30) | SOF+SMV (n = 14) | |||||
Mean | SD | Mean | SD | Mean | SD | ||
SF36: Functional capacity | 58.2 | 25.2 | 55.8 | 25.5 | 66.4 | 29.5 | 0.388 |
SF36: Physical aspects | 40.9 | 40.7 | 36.7 | 42.4 | 66.1 | 36.2 | 0.105 |
SF36: Pain | 59.1 | 26.3 | 57.8 | 30.0 | 60.0 | 27.4 | 0.998 |
SF36: General health state | 60.7 | 21.4 | 56.0 | 22.8 | 66.1 | 16.8 | 0.299 |
SF36: Vitality | 54.1 | 21.5 | 55.5 | 22.1 | 64.6 | 26.7 | 0.447 |
SF36: Social aspects | 81.8 | 20.4 | 71.2 | 27.3 | 72.3 | 26.9 | 0.585 |
SF36: Emotional aspect | 48.5 | 50.3 | 41.1 | 38.8 | 57.1 | 35.6 | 0.447 |
SF36: Mental health | 72.0 | 23.3 | 69.1 | 20.5 | 74.3 | 22.6 | 0.631 |
CLDQ: Abdominal symptoms | 5.5 | 1.6 | 5.1 | 1.7 | 5.9 | 1.3 | 0.203 |
CLDQ: Fatigue | 4.4 | 1.4 | 4.1 | 1.5 | 5.1 | 1.6 | 0.167 |
CLDQ: Systemic symptoms | 5.3 | 1.3 | 5.0 | 1.4 | 5.0 | 1.3 | 0.838 |
CLDQ: Activity | 4.5 | 1.6 | 5.0 | 1.6 | 5.4 | 1.5 | 0.351 |
CLDQ: Emotional function | 5.3 | 1.6 | 4.7 | 1.4 | 5.4 | 1.5 | 0.176 |
CLDQ: Worry | 5.3 | 1.3 | 4.5 | 1.8 | 5.1 | 1.6 | 0.288 |
CLDQ: Total Score | 5.1 | 1.2 | 4.7 | 1.3 | 5.3 | 1.3 | 0.368 |
WPAI: Absenteeism |
0.0 | 0.0 | 6.4 | 12.6 | 0.0 | 0.0 | 0.58 |
WPAI: Presenteeism |
26.7 | 46.2 | 22.2 | 29.5 | 0.0 | 0.0 | 0.373 |
WPAI: Loss of productivity |
26.7 | 46.2 | 18.2 | 22.9 | 0.0 | 0.0 | 0.374 |
WPAI: Decreased activity | 19.1 | 30.8 | 43.7 | 36.7 | 14.3 | 29.5 | 0.011 |
FACIT-F: Physical well-being (PWB) | 22.4 | 5.1 | 20.2 | 5.5 | 21.9 | 7.6 | 0.269 |
FACIT-F: Social/family well-being (SWB) | 19.2 | 6.4 | 19.2 | 5.6 | 18.6 | 5.0 | 0.986 |
FACIT-F: Emotional well-being (EWB) | 17.4 | 4.8 | 17.4 | 3.9 | 19.5 | 4.2 | 0.282 |
FACIT-F: Functional well-being (FWB) | 19.3 | 4.6 | 17.4 | 6.0 | 18.3 | 5.6 | 0.57 |
FACIT-F: Fatigue (FS) | 38.8 | 6.7 | 34.9 | 11.4 | 42.8 | 6.8 | 0.057 |
FACIT-F: TOI (PWB+FWB+FS) | 80.5 | 14.3 | 72.5 | 20.8 | 83.0 | 15.0 | 0.25 |
FACIT-G Total (PWB+SWB+EWB+FWB) | 78.2 | 15.4 | 74.2 | 17.9 | 78.4 | 16.6 | 0.709 |
FACIT-F Total (PWB+SWB+EWB+FWB+FS) | 117.0 | 20.6 | 109.1 | 27.8 | 121.2 | 21.5 | 0.384 |
Variation (D) pre-treatment scores to treatment week 4 | Treatment | p-value by Kruskall-Wallis Test | |||||
---|---|---|---|---|---|---|---|
SOF+DCV (n = 11) | SOF+DCV+RBV (n = 30) | SOF+SMV (n = 14) | |||||
Mean | SD | Mean | SD | Mean | SD | ||
SF36: Functional capacity | −1.82 | 20.16 | −3.83 | 16.01 | 3.93 | 15.59 | 0.588 |
SF36: Physical aspects | 29.55 | 40.03 | 0.0 | 46.54 | 14.29 | 42.42 | 0.238 |
SF36: Pain | 8.73 | 24.21 | −1.5 | 26.13 | 11.0 | 31.73 | 0.632 |
SF36: General health state | −1.45 | 23.01 | 2.97 | 19.22 | 8.14 | 20.15 | 0.304 |
SF36: Vitality | 5.0 | 31.38 | −8.83 | 21.4 | 3.93 | 22.38 | 0.349 |
SF36: Social aspects | −2.27 | 30.01 | −5.42 | 26.2 | 9.82 | 27.81 | 0.144 |
SF36: Emotional aspect | 27.27 | 61.13 | 4.44 | 45.26 | 21.43 | 38.36 | 0.505 |
SF36: Mental health | 0.0 | 23.8 | −7.73 | 21.06 | 8.43 | 12.46 | 0.04 |
CLDQ: Abdominal symptoms | 0.52 | 1.5 | −0.02 | 1.32 | 0.36 | 1.03 | 0.39 |
CLDQ: Fatigue | 0.51 | 2.0 | −0.39 | 1.45 | 0.4 | 1.86 | 0.286 |
CLDQ: Systemic symptoms | 0.02 | 0.75 | −0.13 | 1.02 | 0.69 | 1.09 | 0.08 |
CLDQ: Activity | 0.94 | 2.0 | −0.4 | 1.27 | 0.26 | 1.26 | 0.055 |
CLDQ: Emotional function | 0.25 | 1.39 | −0.1 | 1.27 | 0.35 | 1.18 | 0.433 |
CLDQ: Worry | 0.65 | 1.4 | 0.35 | 1.36 | 0.76 | 1.65 | 0.725 |
CLDQ: Total Score | 0.42 | 1.24 | −0.1 | 0.85 | 0.48 | 1.12 | 0.171 |
WPAI: Absenteeism |
0.0 | 0.0 | 0.45 | 23.99 | 0.0 | 0.0 | 0.942 |
WPAI: Presenteeism |
−26.67 | 46.19 | −3.75 | 31.14 | 2.5 | 5.0 | 0.53 |
WPAI: Loss of productivity |
0.0 | 0.0 | −13.39 | 19.93 | 3.33 | 5.77 | 0.05 |
WPAI: Decreased activity | 9.09 | 18.68 | −4.0 | 32.86 | 2.86 | 31.97 | 0.363 |
FACIT-F: Physical well-being (PWB) | 0.64 | 4.14 | −1.89 | 5.97 | 2.93 | 8.76 | 0.15 |
FACIT-F: Social/family well-being (SWB) | −0.39 | 4.71 | −2.11 | 7.15 | 1.88 | 3.6 | 0.091 |
FACIT-F: Emotional well-being (EWB) | 2.09 | 5.82 | 0.3 | 4.32 | 1.64 | 4.16 | 0.649 |
FACIT-F: Functional well-being (FWB) | 0.97 | 5.31 | −1.6 | 5.76 | 1.39 | 3.42 | 0.273 |
FACIT-F: Fatigue (FS) | 1.4 | 6.75 | −2.74 | 11.58 | 1.21 | 5.75 | 0.318 |
FACIT-F: TOI (PWB+FWB+FS) | 3.01 | 8.8 | −6.23 | 20.93 | 5.54 | 12.1 | 0.109 |
FACIT-G Total (PWB+SWB+EWB+FWB) | 3.3 | 12.45 | −5.3 | 16.67 | 7.84 | 12.96 | 0.072 |
FACIT-F Total (PWB+SWB+EWB+FWB+FS) | 4.7 | 16.2 | −8.04 | 26.39 | 9.05 | 16.53 | 0.087 |
Variation (D) pre-treatment scores to end of treatment | Treatment | p-value by Kruskall-Wallis Test | |||||
---|---|---|---|---|---|---|---|
SOF+DCV (n = 11) | SOF+DCV+RBV (n = 30) | SOF+SMV (n = 14) | |||||
Mean | SD | Mean | SD | Mean | SD | ||
SF36: Functional capacity | 0.0 | 22.47 | 2.17 | 21.04 | 6.79 | 15.14 | 0.688 |
SF36: Physical aspects | 27.27 | 46.71 | 10.0 | 35.11 | 21.43 | 40.26 | 0.427 |
SF36: Pain | 6.82 | 15.15 | −1.57 | 26.58 | 17.71 | 26.79 | 0.06 |
SF36: General health state | −1.27 | 25.92 | 7.3 | 16.29 | 9.36 | 18.48 | 0.242 |
SF36: Vitality | 4.55 | 30.45 | −4.33 | 21.0 | 5.36 | 25.98 | 0.516 |
SF36: Social aspects | 3.41 | 26.86 | −2.92 | 21.94 | 16.07 | 32.68 | 0.201 |
SF36: Emotional aspect | 33.33 | 53.75 | 11.11 | 47.41 | 26.19 | 45.63 | 0.366 |
SF36: Mental health | −3.64 | 26.98 | −4.0 | 18.55 | 3.43 | 21.27 | 0.69 |
CLDQ: Abdominal symptoms | 0.45 | 1.13 | 0.14 | 1.38 | 0.24 | 1.54 | 0.778 |
CLDQ: Fatigue | 1.18 | 1.81 | 0.03 | 1.44 | 0.54 | 1.69 | 0.196 |
CLDQ: Systemic symptoms | 0.22 | 0.89 | −0.19 | 1.04 | 0.46 | 1.44 | 0.238 |
CLDQ: Activity | 1.03 | 1.66 | −0.39 | 1.41 | 0.57 | 1.55 | 0.017 |
CLDQ: Emotional function | 0.32 | 1.79 | 0.1 | 1.13 | 0.34 | 1.22 | 0.963 |
CLDQ: Worry | 0.25 | 1.15 | 0.57 | 1.3 | 0.93 | 0.83 | 0.439 |
CLDQ: Total Score | 0.53 | 1.24 | 0.07 | 0.97 | 0.51 | 1.09 | 0.332 |
WPAI: Absenteeism |
0.0 | 0.0 | 11.67 | 28.58 | 0.0 | 0.0 | 1.000 |
WPAI: Presenteeism |
−26.67 | 46.19 | −3.33 | 18.62 | 7.5 | 9.57 | 0.225 |
WPAI: Loss of productivity |
−40.0 | 56.57 | −9.05 | 22.29 | 10.0 | 10.0 | 0.22 |
WPAI: Decreased activity | −2.73 | 31.01 | −3.33 | 36.8 | −6.43 | 23.73 | 0.661 |
FACIT-F: Physical well-being (PWB) | 2.02 | 4.84 | −0.31 | 5.88 | 4.15 | 7.74 | 0.19 |
FACIT-F: Social/family well-being (SWB) | 0.86 | 3.81 | −0.3 | 6.01 | 2.2 | 5.96 | 0.464 |
FACIT-F: Emotional well-being (EWB) | 0.78 | 4.89 | 1.73 | 4.07 | 1.0 | 2.94 | 0.898 |
FACIT-F: Functional well-being (FWB) | −1.18 | 5.02 | −1.19 | 4.87 | 0.89 | 4.5 | 0.417 |
FACIT-F: Fatigue (FS) | 2.36 | 5.21 | 0.88 | 8.62 | 1.61 | 4.92 | 0.481 |
FACIT-F: TOI (PWB+FWB+FS) | 3.19 | 7.4 | −0.62 | 17.0 | 6.66 | 12.82 | 0.132 |
FACIT-G Total (PWB+SWB+EWB+FWB) | 2.48 | 7.36 | −0.06 | 14.22 | 8.25 | 17.17 | 0.207 |
FACIT-F Total (PWB+SWB+EWB+FWB+FS) | 4.83 | 11.17 | 0.81 | 21.53 | 9.86 | 19.6 | 0.263 |
Variation (D) pre-treatment scores to 4 weeks post end of treatment | Treatment | p-value by Kruskall-Wallis Test | |||||
---|---|---|---|---|---|---|---|
SOF+DCV (n = 11) | SOF+DCV+RBV (n = 30) | SOF+SMV (n = 14) | |||||
Mean | SD | Mean | SD | Mean | SD | ||
SF36: Functional capacity | 9.09 | 22.89 | 7.17 | 22.08 | 11.07 | 16.07 | 0.831 |
SF36: Physical aspects | 34.09 | 45.1 | 10.83 | 41.49 | 19.64 | 38.2 | 0.379 |
SF36: Pain | 7.55 | 13.83 | 0.7 | 20.74 | 16.64 | 23.83 | 0.124 |
SF36: General health state | 4.36 | 17.61 | 5.83 | 18.43 | 15.07 | 16.09 | 0.202 |
SF36: Vitality | 12.27 | 30.11 | 1.5 | 18.62 | 12.5 | 22.85 | 0.396 |
SF36: Social aspects | 6.82 | 25.23 | −0.42 | 26.97 | 23.21 | 24.44 | 0.02 |
SF36: Emotional aspect | 27.27 | 61.13 | 6.67 | 44.12 | 30.95 | 35.72 | 0.153 |
SF36: Mental health | 4.36 | 20.43 | 0.27 | 23.72 | 9.71 | 21.44 | 0.711 |
CLDQ: Abdominal symptoms | 0.88 | 1.55 | 0.36 | 1.39 | 0.19 | 1.34 | 0.699 |
CLDQ: Fatigue | 1.18 | 1.76 | 0.49 | 1.41 | 0.79 | 1.83 | 0.632 |
CLDQ: Systemic symptoms | 0.56 | 0.71 | 0.21 | 0.98 | 0.86 | 1.25 | 0.285 |
CLDQ: Activity | 1.09 | 1.78 | −0.1 | 1.39 | 0.69 | 1.82 | 0.081 |
CLDQ: Emotional function | 0.53 | 1.7 | 0.36 | 1.06 | 0.55 | 1.18 | 0.99 |
CLDQ: Worry | 0.07 | 1.17 | 0.79 | 1.42 | 1.06 | 1.19 | 0.275 |
CLDQ: Total Score | 0.66 | 1.25 | 0.38 | 0.91 | 0.71 | 1.16 | 0.716 |
WPAI: Absenteeism |
0.0 | 0.0 | −3.39 | 7.58 | 0.0 | 0.0 | 1.000 |
WPAI: Presenteeism |
−26.67 | 46.19 | −5.0 | 5.48 | 0.0 | 0.0 | 0.397 |
WPAI: Loss of productivity |
−40.0 | 56.57 | −4.08 | 5.41 | 0.0 | 0.0 | 0.231 |
WPAI: Decreased activity | −9.09 | 28.09 | −10.33 | 39.35 | −3.57 | 40.12 | 0.834 |
FACIT-F: Physical well-being (PWB) | 1.26 | 4.84 | 1.24 | 5.36 | 4.26 | 7.96 | 0.442 |
FACIT-F: Social/family well-being (SWB) | −0.48 | 6.12 | −1.35 | 5.92 | 2.84 | 5.51 | 0.162 |
FACIT-F: Emotional well-being (EWB) | 0.91 | 6.14 | 1.67 | 4.77 | 1.69 | 3.7 | 0.94 |
FACIT-F: Functional well-being (FWB) | 0.27 | 3.61 | −0.62 | 4.92 | 1.33 | 5.21 | 0.476 |
FACIT-F: Fatigue (FS) | 3.93 | 3.29 | 2.02 | 11.84 | 1.71 | 8.17 | 0.484 |
FACIT-F: TOI (PWB+FWB+FS) | 5.46 | 7.89 | 2.64 | 19.75 | 7.31 | 16.36 | 0.448 |
FACIT-G Total (PWB+SWB+EWB+FWB) | 1.95 | 12.33 | 1.01 | 15.85 | 10.12 | 14.7 | 0.116 |
FACIT-F Total (PWB+SWB+EWB+FWB+FS) | 5.89 | 14.63 | 3.03 | 25.87 | 11.83 | 21.55 | 0.393 |
SOF + DCV = sofosbuvir + daclatasvir; SOF + DCV + RBV = sofosbuvir + daclatasvir + ribavirin; SOF + SMV = sofosbuvir + simeprivir.
p-value by the Friedman test for evaluation between the 4 visits The number of registered patients who reported working ranged from 11 to 17. depending on the time of treatment CLDQ = chronic liver disease questionnaire; DCV = daclatasvir; EWB = emotional well being; FACIT-F = functional assessment of chronic illness therapy; FS = fatigue; FWB = functional well being; PWB = physical well being; RBV = ribavirin; SF36 = Medical Outcomes Study 36 – Item Short-Form Health Survey; SMV = simeprivir; SOF = sofosbuvir; SWB = social well being; WPAI = work productivity and activity impairment.
Record for only 16 patients who reported working, frequencies of 3, 9 and 4 patients, respectively. CLDQ = chronic liver disease questionnaire; DCV = daclatasvir; EWB = emotional well being; FACIT-F = functional assessment of chronic illness therapy; FS = fatigue; FWB = functional well being; PWB = physical well being; RBV = ribavirin; SF36 = Medical Outcomes Study 36 – Item Short-Form Health Survey; SMV = simeprivir; SOF = sofosbuvir; SWB = social well being; WPAI = work productivity and activity impairment.
Record for only 16 patients who reported working, frequencies of 3, 9 and 4 patients, respectively. CLDQ = chronic liver disease questionnaire; DCV = daclatasvir; EWB = emotional well being; FACIT-F = functional assessment of chronic illness therapy; FS = fatigue; FWB = functional well being; PWB = physical well being; RBV = ribavirin; SF36 = Medical Outcomes Study 36 – Item Short-Form Health Survey; SMV = simeprivir; SOF = sofosbuvir; SWB = social well being; WPAI = work productivity and activity impairment.
Record for only 16 patients who reported working, frequencies of 3, 9 and 4 patients, respectively. CLDQ = chronic liver disease questionnaire; DCV = daclatasvir; EWB = emotional well being; FACIT-F = functional assessment of chronic illness therapy; FS = fatigue; FWB = functional well being; PWB = physical well being; RBV = ribavirin; SF36 = Medical Outcomes Study 36 – Item Short-Form Health Survey; SMV = simeprivir; SOF = sofosbuvir; SWB = social well being; WPAI = work productivity and activity impairment.
Record for only 16 patients who reported working, frequencies of 3, 9 and 4 patients, respectively. CLDQ = chronic liver disease questionnaire; DCV = daclatasvir; EWB = emotional well being; FACIT-F = functional assessment of chronic illness therapy; FS =; FWB = functional well being; PWB = physical well being PWB = physical well being; RBV = ribavirin; SF36 = Medical Outcomes Study 36 – Item Short-Form Health Survey; SMV = simeprivir; SOF = sofosbuvir; SWB = social well being; WPAI = work productivity and activity impairment.