Prospective Study
Copyright ©The Author(s) 2017.
World J Gastroenterol. Nov 28, 2017; 23(44): 7899-7905
Published online Nov 28, 2017. doi: 10.3748/wjg.v23.i44.7899
Table 1 Baseline characteristics of the patients
CharacteristicsValue
Total participants (n)1375
mean age (yr) mean ± SD (range)48 ± 13 (18-65)
Gender
Male696 (50.62%)
Female679 (49.38%)
Treatment history
Treatment naive490 (35.64%)
Treatment experienced885 (64.36%)
Laboratory investigations
Hemoglobin(Hb) (g/dL), mean ± SD (range)12.50 ± 3.50 (7.5-18.3)
Platelets (103/μL), mean ± SD (range)160 ± 76 (50-450)
Creatinine (mg/dL)0.65 ± 0.22 (0.38-1.50)
Mean viral load (106 IU/mL) mean ± SD (range)3.54 ±2.56 (0.01-33.98)
HCV genotype 31375 (100%)
Table 2 Association of baseline characteristics of the patients with sustained virological response treated with sofosbuvir+ribavirin (First group) n (%)
Baseline characteristics (n = 847)ETR (n = 847), overall ETR = 100%SVR (n = 840), overall SVR = 99.17%Relapse (n = 7), overall relapse rate = 0.83%
Age (yr)
≤ 40 (n = 435)435 (100)433 (99.54)2 (0.46)
> 40 (n = 412)412 (100)407 (98.79)5 (1.21)
Previous antiviral treatment history
Naïve (n = 91)91(100)89 (97.80)2 (2.20)
Treated (n = 756)756 (100)751 (99.34)5 (0.66)
Gender
Male (n = 310)310 (100)309 (99.68)1 (0.32)
Female (n = 537)537 (100)531 (98.88)6 (1.12)
Table 3 Association of baseline characteristics of the patients with sustained virological response treated with sofosbuvir+ribavirin+peg-interferon alfa-2a (Second group) n (%)
Baseline characteristics (n = 528)ETR (n = 526), overall ETR 0.9962SVR (n = 515), overall SVR 0.9791Relapse (n = 11), overall relapse rate = 2.09%
Age (yr)
≤ 40 (n = 419)419 (100)415 (99.05)4 (0.95)
> 40 (n = 109)107 (98.17)100 (93.46)7 (6.54)
Previous antiviral treatment history
Naïve (n = 399)399 (100)396 (99.25)3 (0.75)
Treated (n = 129)127 (98.45)119 (93.70)8 (6.30)
Gender
Male (n = 386)386 (100)382 (98.96)4 (1.04)
Female (n = 142)140 (98.59)133 (95)7 (5)
Table 4 Association of baseline characteristics of the patients with sustained virological response treated with sofosbuvir+ribavirin (First group) n (%)
Time pointViral load (n = 847)ETR (n = 847), overall ETR =100%SVR (n = 840), overall SVR = 99.17%Relapse (n = 7), overall relapse rate = 0.83%
Baseline (d-0)≤ 2 MIU/mL (n = 630)630 (100)628 (99.68)2 (0.32)
> 2 MIU/mL (n = 217)217 (100)212 (97.70)5 (2.30)
RVR (weeks-4)Negative (n = 290)290 (100)290 (100)0 (0)
≥ 2 log drop (n = 540)540 (100)539 (99.81)1 (0.19)
< 2 log drop (n = 17)17 (100)11 (64.70)6 (35.30)
Table 5 Association of baseline characteristics of the patients with sustained virological response treated with sofosbuvir + ribavirin + peg-interferon-alfa-2a (Second group) n (%)
Time pointViral load (n = 528)ETR (n = 526), overall ETR 0.9962SVR (n = 515), overall SVR 0.9791Relapse (n = 11), overall relapse rate = 2.09%
Baseline (d-0)≤ 2 MIU/mL (n = 316)316 (100)313 (99.05)3 (0.95)
> 2 MIU/mL (n = 212)210 (99.06)202 (96.19)8 (3.81)
RVR (weeks-4)Negative (n = 116)116 (100)116 (100)0 (0)
≥ 2 log drop (n = 380)380 (100)376 (98.95)4 (1.05)
< 2 log drop (n = 32)30 (93.75)23 (76.67)7 (23.33)
Table 6 Side effects (n = 1375) n (%)
Side effectsSOF + RBV (n = 847)SOF + RBV + Peg (n = 528)P value
Headache248 (29.28)198 (37.50)0.083
Fatigue147 (17.36)168 (31.82)0.001
Myalgia38 (4.49)43 (8.14)0.830
Hashimoto's thyroiditis2 (0.23)1 (0.19)0.001
Decreased appetite71 (8.38)89 (16.86)0.179
Rash7 (0.82)3 (0.57)0.001
Thrush23 (2.71)19 (3.60)0.467
Hair loss8 (0.94)59 (11.17)0.781
Aggressiveness29 (3.42)38 (7.20)0.895
Pruritus69 (8.14)57 (10.79)0.959
Insomnia79 (9.32)63 (11.93)0.498
Depression36 (4.25)67 (12.69)0.006
Acute psychosis8 (0.94)3 (0.57)0.776
Hematologic abnormalities
Anemia (< 10 g/dL)238 (28.10)215 (40.72)0.001
Leukocytopenia (< 3 × 103/μL)16 (1.89)61 (11.55)0.001
Thrombocytopenia (< 100 × 103/μL)64 (7.56)72 (13.64)0.188
Bell’s Palsy3 (0.35)1 (0.19)0.628
Intracranial hemorrhage2 (0.23)0 (0)