Interferon β-1a alone or in combination with ribavirin: A randomized trial to compare efficacy and safety in chronic hepatitis C

Table 1 Summary of demographic and clinical characteristics at baseline

	Group1	Group 2
Patients (n)	51	51
Sex (M/F)	29/22	36/17
Mean age (yr) ± SD	45±11.7	43.9±9.0
Hemoglobin (g/dL)	14.8±1.3	15±1.3
Platelets (×109/L)	195.9±45	203.9±54
Leukocytes (×109/L)	6.7±1.4	6.8±1.9
ALT (mean±SD)	142.7±86.2	123.2±78.7
HCV-RNA quantitation (Meq/mL)
Low viremia	27	23
High viremia	21	24
Undetermined	3	4
Genotype
1	31	33
2	6	8
3	12	8
4	2	1
Undetermined	0	1

Table 2 Rate (number responding/total treated) of patients with negative viremia during the course of the trial

	Screening	T4	T8	T12	T18	T24	T48
r-hIFN β-1a	0	18	16	21	16	15	11
(n = 51)	0%	-35.30%	-31.40%	-41.20%	-31.40%	-29.40%	-21.56%
r-hIFN β-1a + ribavirin	0	13	22	24	21	21	14
(n = 51)	0%	-25.50%	-43.10%	-47.10%	-41.20%	-41.20%	-27.45%

Table 3 Rate (number responding/total treated) of patients with negative viremia after the 24-wk post-therapy follow-up according to genotype

	1	Non-1	Notdetermined
r-hIFN β-1a	12.90%	35.00%
	(4/31)	(7/20)	–
r-hIFN β-1a + ribavirin	12.10%	52.90%
	(4/33)	(9/17)	(1/1)

Between group difference not significant.

Table 4 Rate (number responding/total treated) of patients with negative viremia after the 24-wk post-therapy follow-up according to viral load (cut-off 800 000 IU)

	Low	High	Not determined
r-hIFN β-1a	33.30%	4.80%
	(9/27)	(1/21)	(1/3)
r-hIFN β-1a + ribavirin	34.80%	16.60%
	(8/23)	(4/24)	(2/4)

Between group difference, P = 0.2972.

Table 5 Adverse events possibly or probably related to study treatment, occurring with a frequency higher than 5%

	r-hIFN β-1a (n = 24, %)	r-hIFN β-1a + ribavirin (n = 35, %)
Fatigue	4 (16.7)	4 (11.4)
Pyrexia	2 (8.3)	6 (17.1)
Anemia	0 (0.0)	6 (17.1)
Erythema	4 (16.7)	2 (5.7)
Headache	4 (16.7)	0 (0.0)
Thrombocytopenia	3 (12.5)	0 (0.0)
Neutropenia	0 (0.0)	2 (5.7)
Depression	2 (8.3)	0 (0.0)
Insomnia	0 (0.0)	2 (5.7)
Weight loss	0 (0.0)	2 (5.7)