Iqbal S, Yousuf MH, Yousaf MI. Dramatic response of hepatitis C patients chronically infected with hepatitis C virus genotype 3 to sofosbuvir-based therapies in Punjab, Pakistan: A prospective study. World J Gastroenterol 2017; 23(44): 7899-7905 [PMID: 29209131 DOI: 10.3748/wjg.v23.i44.7899]
Corresponding Author of This Article
Sajjad Iqbal, PhD, Department of Pathology, Shalamar Hospital, Shalimar Link road Mughal Pura, Lahore 54840, Pakistan. sajjad.iqbal@sihs.org.pk
Research Domain of This Article
Gastroenterology & Hepatology
Article-Type of This Article
Prospective Study
Open-Access Policy of This Article
This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
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
Characteristics
Value
Total participants (n)
1375
mean age (yr) mean ± SD (range)
48 ± 13 (18-65)
Gender
Male
696 (50.62%)
Female
679 (49.38%)
Treatment history
Treatment naive
490 (35.64%)
Treatment experienced
885 (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 3
1375 (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 0.9962
SVR (n = 515), overall SVR 0.9791
Relapse (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 point
Viral 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 point
Viral load (n = 528)
ETR (n = 526), overall ETR 0.9962
SVR (n = 515), overall SVR 0.9791
Relapse (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 effects
SOF + RBV (n = 847)
SOF + RBV + Peg (n = 528)
P value
Headache
248 (29.28)
198 (37.50)
0.083
Fatigue
147 (17.36)
168 (31.82)
0.001
Myalgia
38 (4.49)
43 (8.14)
0.830
Hashimoto's thyroiditis
2 (0.23)
1 (0.19)
0.001
Decreased appetite
71 (8.38)
89 (16.86)
0.179
Rash
7 (0.82)
3 (0.57)
0.001
Thrush
23 (2.71)
19 (3.60)
0.467
Hair loss
8 (0.94)
59 (11.17)
0.781
Aggressiveness
29 (3.42)
38 (7.20)
0.895
Pruritus
69 (8.14)
57 (10.79)
0.959
Insomnia
79 (9.32)
63 (11.93)
0.498
Depression
36 (4.25)
67 (12.69)
0.006
Acute psychosis
8 (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 Palsy
3 (0.35)
1 (0.19)
0.628
Intracranial hemorrhage
2 (0.23)
0 (0)
Citation: Iqbal S, Yousuf MH, Yousaf MI. Dramatic response of hepatitis C patients chronically infected with hepatitis C virus genotype 3 to sofosbuvir-based therapies in Punjab, Pakistan: A prospective study. World J Gastroenterol 2017; 23(44): 7899-7905