Pegylated interferon alfa-2b plus ribavirin for treatment of chronic hepatitis C

Table 1 Baseline characteristics of patients with genotypes 1, 3 and 4

Parameter	Genotype 1	Genotype 3	Genotype 4
	(n = 27)	(n = 56)1	(n = 17)
Age (yr)	41.9 ± 13.2	41.7 ± 10.9	46.3 ± 9.3
Weight (kg)	60.5 ± 12.0	63.3 ± 11.5	63.7 ± 10.8
Male number (%)2	19 (70.3%)	11 (19.7%)	11 (64.7%)
Hemoglobin (g/dL)	14.1 ± 1.6	13.8 ± 1.9	14.2 ± 1.2
White blood cell count (109/L)	6682 ± 1682	7086 ± 1886	7201 ± 1886
Neutrophils (%)	58.4 ± 8.4	56.0 ± 11.8	53.3 ± 8.0
Platelet count (103/L)	200 ± 80	199 ± 78	170 ± 50
Alanine Aminotransferase (U/L)	88.1 ± 41	127.7 ± 87.4	104.9 ± 61.1
HCV RNA log10 IU/mL	5.5 ± 1.2	5.4 ± 1.1	5.5 ± 0.9

¹Includes one patient with genotype 2;

²Value in percentage. HCV: Hepatitis C virus.

Table 2 Percentage of patients who responded in terms of rapid virologic response, early virologic response, end of the treatment virologic response, and sustained virologic response in genotypes 1, 3 and 4 by intention-to-treat analysis

Parameter	Genotype 1	Genotype 31	Genotype 4
	(n = 27)	(n = 56)	(n = 17)
RVR	25.9%	71.4%	58.8%
EVR	74.1%	87.5%	88.2%
ETVR	59.2%	78.6%	70.5%
SVR	44.4%	64.3%	52.9%

¹Includes one patient with genotype 2. RVR: Rapid virologic response; EVR: Early virologic response; SVR: Sustained virologic response; ETVR: End of treatment virologic response.

Table 3 Percentage of patients who responded in terms of rapid virologic response, early virologic response, end of treatment virologic response, and sustained virologic response in genotypes 1, 3 and 4 by per protocol analysis

Parameter	Genotype 1	Genotype 31	Genotype 4
	(n/N)	(n/N)	(n/N)
RVR	25.9% (7/27)	74.1% (40/54)	58.8% (10/17)
EVR	74.1% (20/27)	100% (49/49)	88.2% (15/17)
ETVR	84.2% (16/19)	89.8% (44/49)	75.0% (12/16)
SVR	60.0% (12/20)	76.6% (36/47)	60.0% (9/15)

¹Includes one patient with genotype 2; n: Number of responding patients; N: Total number of patients studied; RVR: Rapid virologic response; EVR: Early virologic response; SVR: Sustained virologic response; ETVR: End of treatment virologic response.

Table 4 Percentage of patients with normalization of alanine aminotransferase levels during different study periods n (%)

Weeks	Genotype 1	Genotype 31	Genotype 4
	(n = 27)	(n = 56)	(n = 17)
4	16 (59.2)	27 (48.2)	8 (47.0)
12	17 (62.9)	29 (51.7)	8 (47.0)
24	17 (62.9)	35 (62.5)	9 (52.9)
48	17 (62.9)	40 (71.4)	11 (64.7)
72	17 (62.9)	-	12 (70.6)

¹Includes one patient with genotype 2.

Table 5 Patients with adverse events

Adverse event	n (%) of patients
	Genotype 1	Genotype 31	Genotype 4
	(n = 27)	(n = 56)	(n = 17)
Injection-site reactions	9 (33.3)	16 (28.6)	7 (41.2)
Flu-like symptoms	24 (88.8)	49 (87.5)	14 (82.3)
Tiredness	4 (14.8)	5 (8.9)	2 (11.7)
Weight loss	1 (3.7)	3 (5.4)	1 (5.8)
Chest discomfort	1 (3.7)	2 (3.6)	2 (11.7)
Arthralgia	3 (11.1)	0 (0)	1 (5.8)
Alopecia	2 (7.4)	10 (17.9)	3 (17.6)
Anorexia	2 (7.4)	7 (12.5)	3 (17.6)
Nausea	3 (11.1)	8 (14.3)	3 (17.6)
Vomiting	2 (7.4)	3 (5.4)	0
Dyspepsia	1 (3.7)	3 (5.4)	2 (11.7)
Gastritis	1 (3.7)	0 (0)	0
Mucous stool	1 (3.7)	0 (0)	0
Diarrhea	1 (3.7)	4 (7.1)	1 (5.8)
Melena	1 (3.7)	6 (10.7)	0
Ascites	1 (3.7)	0 (0)	0
Thrombocytopenia	2 (7.4)	5 (8.9)	1 (5.8)
Anemia	9 (33.3)	13 (23.2)	6 (35.3)
Neutropenia	12 (44.4)	15 (26.8)	8 (47.0)
Anxiety	1 (3.7)	3 (5.4)	1 (5.8)
Depression	2 (7.4)	4 (7.1)	3 (17.6)
Insomnia	1 (3.7)	1 (1.8)	2 (11.7)
Hypothyroidism	2 (7.4)	2 (3.6)	2 (11.7)
Giddiness	1 (3.7)	1 (1.8)	2 (11.7)
Dry throat	1 (3.7)	1 (1.8)	0 (0)
Cough	2 (7.4)	2 (3.6)	2 (11.7)
Sinusitis	1 (3.7)	0 (0)	0 (0)
Bleeding gums	2 (7.4)	1 (1.8)	0 (0)
Palpitation	1 (3.7)	0 (0)	0 (0)
Pruritus	0 (0)	0 (0)	1 (5.8)
Yellow-colored sputum	0 (0)	0 (0)	1 (5.8)
Urinary tract infection	1 (3.7)	0 (0)	0 (0)
Death	0 (0)	1 (1.8)	0 (0)
No. of patients reporting AEs	24 (88.8)	49 (87.5)	14 (82.3)
Discontinued due to SAEs	0 (0)	2 (3.6)	0 (0)
Temporary discontinuation of therapy	4 (14.8)	3 (5.4)	3 (17.6)
Temporary dose reduction	11 (40.7)	16 (29.6)	5 (29.4)

¹Includes one patient with genotype 2. SAE: Serious adverse event.