Treatment of hepatitis C virus genotype 4 with peginterferon alfa-2a: Impact of bilharziasis and fibrosis stage

Table 1 Demographic data of the hepatitis C patients

Variable	Group A(PEG-IFN+RBV)n = 38	Group B(IFN+RBV)n = 35	P
Age (yr) (mean ± SD)	45.5 ± 6.1	45.4 ± 5.8	NS1
Gender
Male	31 (81.6)	33 (94.3)
Female	7 (18.4)	2 (5.7)
Body mass (mean ± SD)
Before treatment	81.9 ± 12.0	73.6 ± 7.7	0.001
After Treatment	78.9 ± 12.5	71.1 ± 7.4	0.002
Weight reduction	2.9 ± 4.3	2.6 ± 2.7	NS1
Inflammation stage
0-1	7 (18.4)	8 (22.9)	NS1
2-3	31 (81.6)	27 (77.1)
Grade of fibrosis
Mild (0-2)	25 (65.8)	23 (65.7)	NS1
Severe (3-4)	13 (34.2)	12 (34.3)
Bilharzial co-infection No.	31 (81.6)	30 (5.7)

¹Not significant.

Table 2 Comparison of response of hepatitis C in both groups

Variable	Group A(PEG-IFN+RBV)n = 38	Group B(IFN+RBV)n = 35	P
After 48 wk
Responders	29 (76.3)	14 (40.0)	< 0.002
Non-responders	9 (23.7)	21 (60.0)
After 72 wk
Among responders
Sustained response	25 (86.2)	9 (64.3)	0.124
Relapser	4 (13.8)	5 (35.7)

Table 3 Comparison between responders and non-responders in both hepatitis C groups (mean ± SD)

Variable	Group A (PEG-IFN+RBV) n = 38			Group B (IFN+RBV) n = 35
	R1	NR2	SR3	R1	NR2	SR3
Age (yr)	44.7 ± 5.4	47.8 ± 7.9	44.2 ± 5.8	45.23 ± 5.2	45.6 ± 6.2	42.9 ± 4.6
Body mass (kg)	82.6 ± 10.2	79.7 ± 17.0	82.7 ± 9.8	74.6 ± 9.5	73.1 ± 6.6	77.3 ± 9.6
ALT (μkat/L)
Before treatment	2.559 ± 1.564	1.524 ± 0.082	2.757 ± 1.607	1.494 ± 0.432	1.810 ± 0.570	1.524 ± 0.515
After 3 mo	1.065 ± 0.980	1.095 ± 0.767	1.084 ± 1.039	0.405 ± 0.112	1.135 ± 0.741	0.487 ± 0.263
Baseline HCV RNA (MU/L)	473 934 ± 373 542	496 256 ± 667 356	472 444 ± 402 109	312 786 ± 185 583	361 857 ± 339 942	346 667 ± 207 364

¹Responders;

²Non responder;

³Sustained response.

Table 4 Comparison of response in both hepatitis C groups according to histopathological changes n (%)

Variable	n	Responders	Non responders	Among responders
				Sustained response	Relapse
Severe Fibrosis
A1	13	8 (61.5)	5 (38.5)	5 (62.5)	3 (37.5)
B2	11	1 (9.1)	10 (90.9)	0 (0.0)	1 (100.0)
Mild fibrosis
A1	25	21 (84.0)	4 (15.0)	20 (95.2)	1 (4.8)
B2	24	13 (54.2)	11 (45.8)	9 (69.2)	4 (30.8)
Severe inflammation
A1	31	22 (71.0)	9 (29.0)	18 (81.8)	4 (18.2)
B2	27	7 (25.9)	20 (74.1)	4 (57.1)	3 (42.9)
Mild inflammation
A1	7	7 (100.0)	0 (0.0)	7 (100.0)	0 (0.0)

¹Group A = PEG-IFN+RBV;

²Group B = IFN + RBV.

Table 5 Comparison between responders and non-responders in both hepatitis C groups

Variable	Respondersn =43	NonRespondersn =30	P
Gender
Male	38 (88.4)	26 (86.7)	NS1
Female	5 (11.6)	4 (13.3)
Body mass (kg, Mean ± SD)
Before treatment	80.1 ± 10.6	75.1 ± 10.9	NS1
After treatment	76.9 ± 10.6	72.9 ± 11.5	NS1
ALT
Pre treatment	141.1 ± 88.9	101.2 ± 41.0	NS1
12 wk	56.2 ± 55.0	67.1 ± 44.0	NS1
48 wk	38.1 ± 22.7	65.0 ± 30.6	NS1
			NS1
PCR (No. of viruses in BL; mean ± SD)
Pre treatment	416 328 ± 341 106	337 321 ± 482 826	0.036
Liver fibrosis
Grade 1	17 (39.5)	3 (10.3)	0.009
Grade 2	17 (39.5)	11 (37.9)
Grade 3	8 (18.6)	8 (27.6)
Grade 4	1 (2.4)	7 (24.1)
HCV vs HCV and Bilharziasis
Co-infected	37 (84.1)	24 (82.8)	NS1
Non Bilharzial	7 (15.9)	5 (17.2)
Drug used
Pegasus	29 (67.4)	9 (30.0)	0.002
Non-pegylated IFN	14 (32.6)	21 (70.0)

¹Not significant.

Table 6 Comparison of side effects in both hepatitis C groups

Variable	Group A	Group B	P
Flu-like symptoms	40 (100.0)	40 (100.0)
Discontinuation of drug	0 (0)	0 (0)	NS1
Thyroid dysfunction	2	3	NS1
Discontinuation of drug	1	2
Psychological upset and drug intolerability	1	1	NS1
Discontinuation of drug	1	1
Hematological
Anemia (30% from baseline)	13 (26.0)	12 (24.0)	NS1
Neutropenia (< 0.9 × 109/L)	21 (42.0)	19 (38.0)	NS1
Thrombocytopenia (< 50 × 109/L)	None	2 (4)	NS1

¹Not significant.