Factors associated with early virological response to peginterferon-α-2a/ribavirin in chronic hepatitis C

Table 1 Patient baseline characteristics n (%)

Characteristics
Patient sociodemographics
Sex
Male	712 (70)
Female	302 (30)
Age (yr), mean ± SD	44.3 ± 9.8
Nationality
Spanish	919 (91)
Other	93 (9)
Race
Caucasian	980 (97)
Other	27 (3)
Educational level
Did not complete compulsory education	125 (12)
Compulsory education	506 (50)
Professional training	243 (24)
University	131 (13)
Postgraduate/Master/PhD	7 (1)
Marital status
Single	280 (28)
Married	580 (58)
Separated	138 (14)
Widowed	11 (1)
Family status
Lives with another person	898 (89)
Lives alone	97 (10)
Prison inmate	16 (2)
Clinical characteristics
Weight (kg), mean ± SD	75.7 ± 13.4
Alcohol consumption	154 (15)
Tobacco consumption	514 (51)
Source of HCV infection1
IVDU	256 (25)
Transfusion	234 (23)
Other	55 (6)
Unknown	462 (46)
Methadone replacement therapy	65 (7)
ALT (IU/mL), mean ± SD	88.4 ± 69.7
AST (IU/mL), mean ± SD	73.9 ± 64.4
GGT (IU/mL), mean ± SD	82.0 ± 91.6
Ferritin (μg/L), mean ± SD	266.0 ± 284.8
Cirrhosis	62 (6.2)
HCV genotype
1/4	784 (78)
2/3	223 (22)
HCV-RNA
< 400 000 IU/mL	264 (26)
≥ 400 000 IU/mL	744 (73)

¹One patient could have more than one presumed source of infection. Data are presented as number (percentage) of patients unless otherwise indicated. Proportions of patients are presented as valid percentages. Percentages may not add up to 100 due to rounding error. Values for age, weight and serum levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyl transferase (GGT) and ferritin are expressed as mean ± SD. IVDUs: Intravenous drug users; HCV RNA: Hepatitis C virus ribonucleic acid.

Table 2 Treatment n (%)

Treatment data
Peginterferon α-2a
Dose: 180 mg	1014 (100)
At least one dose reduction of peginterferon	66 (7)1
At least one discontinuation of peginterferon	46 (81)
Ribavirin
Dose
800 mg/d	183 (18)
1000 mg/d	413 (41)
1200 mg/d	416 (41)
1400 mg/d	1 (0.1)
At least one dose reduction of ribavirin	66 (7)1
At least one discontinuation of ribavirin	56 (89)
Scheduled treatment duration
24 wk	234 (23)
48 wk	773 (77)

¹The percentage of patients with dose reduction of peginterferon α-2a and the frequency of patients with dose reduction of ribavirin coincide, but are not exactly the same patients. The frequencies presented correspond to valid percentages. Percentages may not add up to 100 due to rounding error.

Table 3 Sociodemographics, clinical and pathological characteristics of patients with early virological response and non-early virological response by bivariate analysis n (%)

Factors	EVR	Non-EVR	P value1
Patient sociodemographics
Age (yr), mean ± SD	43.9 ± 9.7	47.0 ± 10.0	< 0.005
Sex
Male	602 (86)	101 (14)	NS
Female	264 (89)	33 (11)
Origin
Developed country	64 (93)	5 (7)	NS
Developing country	801 (86)	129 (14)
Race
Caucasian	836 (87)	130 (14)	NS
Other	24 (89)	3 (11)
Educational level
Equivalent to or less than high	537 (86)	85 (14)	NS
Professional training	209 (87)	31 (13)
University or higher	119 (88)	17 (13)
Marital status
Single	235 (85)	41 (15)	NS
Married	491 (86)	81 (14)
Separated/divorced/widowed	135 (92)	12 (8)
Family status
Lives alone	82 (85)	15 (16)	NS
Lives with another person	769 (87)	117 (13)
Clinical characteristics
Weight (kg), mean ± SD	75.6 ± 13.4	77.2 ± 13.5	NS
Alcohol consumption
No	731 (86)	115 (14)	NS
Yes	133 (88)	19 (13)
Tobacco consumption
No	414 (85)	75 (15)	NS
Yes	450 (88)	59 (12)
Source of HCV infection
Injection drug use	221 (90)	26 (11)	NS
Transfusion	126 (89)	16 (11)
IV route	79 (87)	12 (13)
Other	435 (85)	78 (15)
Methadone replacement therapy
No	803 (86)	126 (14)	NS
Yes	57 (89)	7 (11)
ALT (IU/mL), mean ± SD	86.3 ± 69.4	101.7 ± 71.5	< 0.05
AST (IU/mL), mean ± SD	72.1 ± 65.3	84.8 ± 58.5	< 0.05
GGT (IU/mL), mean ± SD	73.6 ± 85.2	134.0 ± 114.4	< 0.001
Ferritin (μg/L), mean ± SD	248.0 ± 268.8	388.8 ± 357.3	< 0.001
Cirrhosis
No	817 (88)	112 (12)	< 0.001
Yes	41 (67)	20 (33)
HCV genotype
1/4	645 (84)	126 (16)	< 0.001
2/3	214 (96)	8 (4)
HCV-RNA (IU/mL), mean ± SD	3 354 135.6 ± 5 978 359.9	3 781 940.0 ± 4 780 000.6	NS
Baseline viral load
< 400 000 IU/mL	237 (91)	25 (10)	< 0.05
≥ 400 000 IU/mL	623 (85)	109 (15)

Data are presented as number (percentage) of patients unless otherwise indicated. Proportions of patients are presented as valid percentages. Values for age, weight, and alanine aminotransferase/aspartate aminotransferase (ALT/AST), gamma glutamyl transferase (GGT) and ferritin are expressed as mean ± SD.

¹P value of bivariate analysis. EVR: early virological response; HCV-RNA: Hepatitis C virus ribonucleic acid; IV route: Intravenous route; NS: Not significant.