Pegylated interferon α-2b plus ribavirin for older patients with chronic hepatitis C

Table 1 Characteristics of 938 chronic hepatitis C genotype 1 patients treated with a combination of pegylated interferon plus ribavirin according to age (mean ± SD)

	Group A (age < 65 yr) (n = 685)	Group B (age≥65 yr) (n = 253)	P-value
Age (yr)	53.1 ± 8.9	68.6 ± 3.1	< 0.001
Male/female	374/311	122/131	0.090
Body mass index (kg/m2)	23.7 ± 3.3	22.8 ± 2.7	< 0.001
Prior IFN monotherapy, n (%)	163 (23.8)	76 (30.0)	0.052
Prior combined IFN plus RBV treatment, n (%)	51 (7.4)	20 (7.9)	< 0.001
Alanine aminotransferase (IU/L)	80.2 ± 62.0	67.9 ± 46.6	0.004
γ-glutamyltranspeptidase (IU/L)	60.2 ± 56.6	57.1 ± 49.2	0.708
Albumin (g/dL)	4.1 ± 0.4	4.0 ± 0.4	< 0.001
White blood cell count (/mm3)	5200.0 ± 1476.7	4756.3 ± 1458.9	< 0.001
Hemoglobin (g/dL)	14.1 ± 1.4	13. 5 ± 1.4	< 0.001
Platelet count (109/L)	16.6 ± 5.3	15.0 ± 5.2	< 0.001
Creatinine (mg/dL)	0.7 ± 0.6	0.8 ± 1.4	0.107
Creatinine clearance (mL/min)	105.5 ± 28.7	75.8 ± 17.5	< 0.001
Serum HCV-RNA level (kIU/mL)	1776.1 ± 1500.0	1986.9 ± 1604.5	0.125
Histological fibrosis			0.008
F0/F1/F2/F3/F4	36/155/121/61/30	9/46/49/31/17

IFN: Interferon; RBV: Ribavirin; HCV: Hepatitis C virus.

Table 2 Characteristics of 313 chronic hepatitis C genotype 2 patients treated with a combination of pegylated interferon plus ribavirin according to age (mean ± SD)

	Group C (age < 65 yr) (n = 252)	Group D (age≥65 yr) (n = 61)	P-value
Age (yr)	47.7 ± 10.4	69.2 ± 3.4	< 0.001
Male/female	124/128	28/33	0.671
Body mass index (kg/m2)	23.1 ± 3.5	22.8 ± 2.9	0.577
Prior IFN monotherapy, n (%)	47 (18.7)	16 (26.2)	< 0.001
Prior combined IFN plus RBV treatment, n (%)	5 (2.0)	4 (6.6)	0.056
Alanine aminotransferase (IU/L)	79.9 ± 78.7	68.9 ± 52.9	0.821
γ-glutamyltranspeptidase (IU/L)	55.8 ± 64.7	44.3 ± 34.7	0.937
Albumin (g/dL)	4.2 ± 0.4	3.9 ± 0.5	< 0.001
White blood cell count (/mm3)	5276.3 ± 1636.3	4958.0 ± 1495.6	0.005
Hemoglobin (g/dL)	14.1 ± 1.4	13.4 ± 1.3	< 0.001
Platelet count (109/L)	18.9 ± 6.3	15.6 ± 4.7	< 0.001
Creatinine (mg/dL)	0.8 ± 1.5	0.7 ± 0.2	0.581
Creatinine clearance (mL/min)	112.1 ± 31.4	74.6 ± 17.2	< 0.001
Serum HCV-RNA level (kIU/mL)	1588.3 ± 1628.7	1195.4 ± 1645.5	0.038
Histological fibrosis			< 0.001
F0/F1/F2/F3/F4	30/77/39/10/10	1/21/9/2/12

IFN: Interferon; RBV: Ribavirin; HCV: Hepatitis C virus.

Table 3 The comparison of the rate of sustained virological response of patients with genotype 1 receiving a dose of 80% or more of pegylated interferon α-2b plus 60% or more of ribavirin and the reduced dosage group n (%)

	Male		Female		Total
	n	SVR	n	SVR	n	SVR
Group A
Minimum acceptable	168	116 (69.0)	110	69 (62.7)	278	185 (66.5)
Reduced	206	73 (35.4)	201	66 (32.8)	407	139 (34.2)
Total	374	189 (50.5)	311	135 (43.4)	685	324 (47.3)
Group B
Minimum acceptable	31	15 (48.4)	31	13 (41.9)	62	28 (45.2)
Reduced	91	18 (19.8)	100	12 (12.0)	191	30 (15.7)
Total	122	33 (27.0)	131	25 (19.1)	253	58 (22.9)

Minimum acceptable: patients who received 80% or more of the target dose of pegylated interferon (IFN) α-2b and 60% or more of ribavirin (RBV). Reduced: Patients who received less than 80% of pegylated IFN α-2b and less than 60% of RBV. SVR: Sustained virological response.

Table 4 Reasons for discontinuation of pegylated interferon plus ribavirin treatment by hepatitis C virus genotype 1 patients

	Group A (age < 65 yr)		Group B (age≥65 yr)		Total
	Male (n = 374)	Female (n = 311)	Male (n = 122)	Female (n = 131)
Discontinued number	101	66	52	54	273
Adverse effects	43	31	33	28	135
General fatigue	17	7	12	11	47
Depression	3	11	4	5	23
Appetite loss	1	0	1	0	2
Rash	3	2	3	4	12
Encephalopathy	1	0	0	0	1
Neutropenia	2	0	0	0	2
Anemia	3	2	4	1	10
Thrombocytopenia	1	0	3	1	5
Elevation of ALT	1	0	0	0	1
Hyperthyroidism	3	2	0	1	6
Hypothyroidism	0	1	0	0	1
Retinopathy	1	0	1	0	2
Interstitial pneumonia	2	0	1	1	4
Pulmonary disease (others)1	0	1	1	1	3
Psychoneurotic disorder2	2	0	2	0	4
Nervous disease3	1	1	0	1	3
Autoimmune disease4	0	2	0	1	3
Metabolic disease5	0	2	0	0	2
Digestive disorder6	2	0	1	1	4
Hepatocellular carcinoma	2	0	4	1	7
Malignancy (extra-liver)	0	1	1	0	2
No effect of treatment	22	18	7	8	55
Economic problem	9	3	0	3	15
Others7	25	13	7	14	59

¹Includes pulmonary tuberculosis (n = 1), pneumonia (n = 1), tuberculous pleuritis (n = 1);

²Includes psychiatric disorder (n = 2), disquiet (n = 1), insomnia (n = 1);

³Includes nerve paralysis (n = 1), cerebral infarction (n = 1);

⁴Includes rheumatoid arthritis (n = 2), myasthenia gravis (n = 1);

⁵Includes diabetes mellitus (n = 1), hypertriglycemia (n = 1);

⁶Includes cholecystitis (n = 3), pancreatitis (n = 1);

⁷Includes 25, 13, 6 and 13 drop-outs from groups A, B, C and D, respectively: One for excessive alcohol consumption in group C and one was nursing in group D. ALT: Alanine aminotransferase.

Table 5 Reasons for discontinuation of pegylated interferon plus ribavirin treatment by hepatitis C virus genotype 2 patients

	Group C (age < 65 yr)		Group D (age≥65 yr)		Total
	Male (n = 124)	Female (n = 128)	Male (n = 28)	Female (n = 33)
Discontinued number	18	15	4	4	41
Adverse effects	6	11	3	3	23
General fatigue	1	3	1	0	5
Depression	0	2	0	0	2
Appetite loss	0	0	0	0	0
Rash	2	1	0	2	5
Encephalopathy	0	0	0	1	1
Neutropenia	0	2	0	0	2
Anemia	0	0	2	0	2
Thrombocytopenia	2	0	0	0	2
Elevation of ALT	0	0	0	0	0
Hyperthyroidism	0	1	0	0	1
Hypothyroidism	0	1	0	0	1
Retinopathy	0	0	0	0	0
Interstitial pneumonia	0	0	0	0	0
Pulmonary disease(others)	0	0	0	0	0
Psychoneurotic disorder	0	0	0	0	0
Nervous disease1	1	1	0	0	2
Autoimmune disease	0	0	0	0	0
Metabolic disease	0	0	0	0	0
Digestive disorder	0	0	0	0	0
Hepatocellular carcinoma	0	0	0	0	0
Malignancy (extra-liver)	1	0	0	0	1
No effect of treatment	1	0	0	0	1
Economic problem	0	0	0	0	0
Others2	10	4	1	1	16

¹Includes nerve paralysis (n = 1), tetany (n = 1);

²All patients were drop out. ALT: Alanine aminotransferase.