Ketoprofen, peginterferon 2a and ribavirin for genotype 1 chronic hepatitis C: A phase II study

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

¹HAI: Histological activity index according to Knodell et al[22]. PR: PEG-IFNα2a plus ribavirin; PK: PEG-IFNα2a plus ketoprofen; PRK: PEG-IFNα2a plus ribavirin and ketoprofen; M: Male; F: Female; HCV: Hepatitis C virus; ALT: Alanine aminotransferase; NS: Not significant.

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

ETR: End of treatment response; SVR: Sustained virological response.

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