Copyright
©2009 The WJG Press and Baishideng.
World J Gastroenterol. Dec 21, 2009; 15(47): 5946-5952
Published online Dec 21, 2009. doi: 10.3748/wjg.15.5946
Published online Dec 21, 2009. doi: 10.3748/wjg.15.5946
Table 1 Baseline characteristics of enrolled patients (mean ± SD)
PR group (n = 15) | PK group (n = 16) | PRK group (n = 14) | P-value | |
Age (yr) | 45 ± 12 | 48 ± 12 | 42 ± 10 | NS |
Sex (M/F) | 9/6 | 9/7 | 9/5 | NS |
HCV-RNA × 103 IU/mL | 429 ± 578 | 1261 ± 1073 | 1555 ± 1322 | 0.01 |
HCV-RNA > 700 × 103 IU/mL (%) | 4 (27) | 8 (50) | 10 (71) | 0.02 |
ALT (U/L) | 82 ± 45 | 85 ± 33 | 87 ± 49 | NS |
Median total HAI1 (range) | 8 (3-14) | 10 (6-13) | 8 (3-10) | NS |
Median grading (range) | 7 (2-11) | 9 (5-10) | 7 (3-9) | NS |
Median fibrosis (range) | 1 (1-3) | 1 (1-3) | 1 (0-3) | NS |
Table 2 Virological response rates by study group n (%)
PR group (n = 15) | PK group (n = 16) | PRK group (n = 14) | P-value | |
Virological response rate | ||||
Week 1 | 0 | 0 | 1 (7.1) | NS |
Week 2 | 1 (6.7) | 1 (6.3) | 2 (14.3) | NS |
Week 4 | 5 (33.3) | 2 (12.5) | 3 (21.4) | NS |
Week 12 | 10 (66.7) | 7 (43.8) | 7 (50) | NS |
Week 24 | 11 (73.3) | 11 (68.8) | 10 (71.4) | NS |
ETR | 11 (73.3) | 11 (68.8) | 10 (71.4) | NS |
Relapse rate | 4/11 (36.4) | 6/11 (54.5) | 2/10 (20) | NS |
SVR | 7 (46.7) | 5 (31.3) | 8 (57.1) | NS |
Table 3 Baseline characteristics of the patients enrolled in the molecular study (mean ± SD) n (%)
PR group (n = 9) | PK group (n = 9) | PRK group (n = 9) | P-value | |
Age (yr) | 42 ± 13 | 54 ± 9 | 42 ± 12 | 0.04 |
Sex (M/F) | 5/4 | 4/5 | 5/4 | NS |
HCV-RNA × 103 IU/mL | 263 ± 232 | 1032 ± 878 | 1742 ± 1392 | 0.01 |
HCV-RNA > 700 × 103 IU/mL | 1 (27) | 4 (44) | 7 (78) | 0.02 |
ALT (U/L) | 70 ± 21 | 80 ± 27 | 100 ± 57 | NS |
ETR | 7 (78) | 5 (56) | 6 (67) | NS |
SVR | 5 (56) | 3 (33) | 5 (56) | NS |
Table 4 Side effects occurring during 48 wk of treatment n (%)
PR group (n = 15) | PK group (n = 16) | PRK group (n = 14) | P-value | |
Anemia | 8 (53) | 7 (44) | 11 (79) | NS |
Neutropenia | 9 (60) | 7 (44) | 10 (71) | NS |
Arthro-myalgia | 4 (27) | 4 (25) | 5 (36) | NS |
Headache | 3 (20) | 3 (19) | 2 (14) | NS |
Fatigue | 5 (33) | 5 (31) | 4 (29) | NS |
Flu-like symptoms | 4 (27) | 4 (25) | 2 (14) | NS |
Psychiatric disorders | 5 (33) | 4 (25) | 4 (29) | NS |
Gastrointestinal disorders | 6 (40) | 3 (19) | 4 (29) | NS |
Pruritus | 4 (27) | 1 (6) | 0 | NS |
Insomnia | 2 (13) | 2 (12.5) | 2 (14) | NS |
Table 5 Time course evaluation of hemoglobin and creatinine serum levels during treatment (mean ± SD)
PR group (n = 15) | PK group (n = 16) | PRK group (n = 14) | |
Hemoglobin (g/dL) | |||
Baseline | 14.5 ± 1.3 | 14.2 ± 1.9 | 14.9 ± 1.5 |
Week 12 | 12.2 ± 1.4 | 12.5 ± 1.7 | 12.2 ± 1.6 |
Week 24 | 12.2 ± 1.6 | 12.6 ± 1.8 | 11.9 ± 1.7 |
Week 48 | 11.6 ± 1.4 | 13.1 ± 1.8 | 12.0 ± 1.6 |
Creatinine (mg/dL) | |||
Baseline | 0.97 ± 0.13 | 0.82 ± 0.22 | 1.01 ± 0.07 |
Week 12 | 0.87 ± 0.11 | 0.82 ± 0.16 | 0.92 ± 0.12 |
Week 24 | 0.86 ± 0.15 | 0.79 ± 0.16 | 0.91 ± 0.15 |
Week 48 | 0.44 ± 0.15 | 0.80 ± 0.17 | 0.92 ± 0.15 |
- Citation: Gramenzi A, Cursaro C, Margotti M, Balsano C, Spaziani A, Anticoli S, Loggi E, Salerno M, Galli S, Furlini G, Bernardi M, Andreone P. Ketoprofen, peginterferon 2a and ribavirin for genotype 1 chronic hepatitis C: A phase II study. World J Gastroenterol 2009; 15(47): 5946-5952
- URL: https://www.wjgnet.com/1007-9327/full/v15/i47/5946.htm
- DOI: https://dx.doi.org/10.3748/wjg.15.5946