Safety and efficacy of Hansenula-derived PEGylated-interferon alpha-2a and ribavirin combination in chronic hepatitis C Egyptian children

Table 1 Demographic, laboratory and histopathological parameters in all patients n (%)

Parameter	All patients (n = 46)
Age (yr)	10.32 ± 3.46
Male	33 (71.7)
Duration of infection (yr)	5.29 ± 3.97
BMI	18.20 ± 2.77
Possible risk of infection
Surgery	14 (30.4)
Blood transfusion	16 (34.8)
Tonsillectomy	5 (10.9)
Circumcision	33 (71.7)
Minor procedures1	30 (65.2)
Vertical transmission	8 (17.4)
Family contact	18 (39.1)
More than one possible risk	43 (93.5)
Unknown risk factor	3 (6.5)
Hemoglobin (g/dL)	12.5 ± 1.1
ANC (× 103/μL)	3.13 ± 1.7
Platelets (× 103/μL)	280.7 ± 82.4
Albumin (g/dL)	4.1 ± 0.37
Alanine transaminase (U/L)	56.6 ± 55.03
Aspartate transaminase (U/L)	49.2 ± 31.65
Gamma-glutamyl transpeptidase (U/L)	32.1 ± 26.6
Alkaline phosphatase (U/L)	212.5 ± 96.1
Prothrombin time (sec)	12.9 ± 0.62
Hepatomegaly (US)	3 (15.9)
Splenomegaly (US)	3 (15.9)
Viremia (IU/mL)
Low ( ≤ 2 × 105 IU/mL)	19 (41.3)
Moderate (> 2 × 105 - 2 × 106 IU/mL)	25 (54.3)
High (> 2 × 106 IU/mL)	2 (4.3)
Genotype:
4a	30 (65.2)
4b	8 (17.4)
Not determined	8 (17.4)
Fibrosis stage
Absent	13 (28.9)
Mild	30 (66.7)
Moderate	2 (4.4)
Activity grade
Mild	44 (97.8)
Moderate	1 (2.2)

¹Minor procedures were: Sutures, abscess drainage, ICU hospitalization, endoscopy, ear piercing, tattooing, prolonged hospitalization and dental care. US: Ultrasound; BMI: Body mass index.

Table 2 Response outcome

Response type	n = 46
End of treatment response	13 (28.2)
SVR	11 (23.9)
Dropped out SVR	2 (4.3)
Non-responder	14 (30.4)
Breakthrough	18 (39.1)
Delayed responders ended by breakthrough	8 (17.4)
Breakthrough ended at 48 wk as non-responders	8 (17.4)
Breakthrough ended at 72 wk by relapse	2 (4.3)
Relapse	1 (2.17)

Two patients who had end of treatment response (ETR) but were lost to follow up. SVR: Sustained virological response.

Table 3 Comparison between patients with sustained virological response and non-sustained virological response according to different variables n (%)

Parameter	SVR	Non-SVR	P value
	(n = 11)	(n = 33)
Center:
CUPH	1 (9)	9 (27.3)	0.330
YAGCC	5 (45.5)	13 (39.4)
NLI	5 (45.5)	11 (33.3)
Age (yr)	9.9 ± 3.76	10.39 ± 3.45	0.385
Male	9 (81.8)	22 (66.7)	0.340
Expected duration of infection (yr)	3.77 ± 3.28	5.61 ± 4.02	0.341
Previous treatment trial	2 (18.2)	9 (27.3)	0.546
Previous treatment type2
Short-acting IFN + RBV	2 (100)	8 (88.9)	1.000
PEG-IFN + RBV	0 (0)	1 (11.1)
Previous response type2
Non-responder	0 (0)	7 (77.8)	0.0391
Relapser	2 (100)	2 (22.2)
Possible cause of infection
Surgery	4 (36.4)	10 (30.3)	0.709
Blood transfusion	4 (36.4)	11 (33.3)	0.854
Tonsillectomy	1 (9.1)	4 (12.1)	0.784
Circumcision	9 (81.8)	22 (66.7)	0.340
Minor procedures	8 (72.7)	22 (66.7)	0.709
Vertical transmission	2 (18.2)	6 (18.2)	1.000
Family contact	4 (36.4)	14 (42.4)	0.723
Injection interval:
5 d	1 (9)	16 (48.5)	0.0201
7 d	10 (91)	17 (51.5)
Treatment duration:
48 wk	9 (81.8)	27 (81.8)	0.940
72 wk	2 (18.2)	6 (18.2)
Genotype:
4a	4 (80)	24 (77.4)	0.890
4b	1 (20)	7 (22.6)
Viral load:
Low	7 (64)	11 (33.4)	0.180
Moderate	4 (36)	20 (60.6)
High	0 (0)	2 (6.0)
Histological Activity:
Mild	11 (100)	31 (96.9)	0.550
Moderate	0 (0)	1 (3.1)
Fibrosis stage:
No	1 (9.1)	12 (37.5)	0.112
Mild	10 (90.9)	18 (56.3)
Moderate	0 (0)	2 (6.3)
Steatosis:
No	11 (100)	28 (87.5)	0.460
Mild	0 (0)	3 (9.4)
Moderate	0 (0)	1 (3.1)

¹Significant;

²Percentages were calculated for those with previous treatment trial. SVR: Sustained virological response.

Table 4 Rapid virological response, early virological response, polymerase chain reaction at week 24, and end of treatment response in sustained virological response vs non-sustained virological response n (%)

Parameter	RVR	EVR	PCR at week 24	ETR
SVR (n = 11)	9 (81.8)	10 (90.9)	11 (100)	11 (100)
Non-SVR (n = 33)	13 (39.4)	12 (36.4)	0 (0)	0 (0)
P value	0.0151	0.0021	< 0.0011	< 0.0011

¹Significant. SVR: Sustained virological response; ETR: End of treatment response; PCR: Polymerase chain reaction; EVR: Early virological response.

Table 5 Predictive value of rapid virological response and early virological response to sustained virological response

	Sensitivity	Specificity	PPV	NPV
RVR	81.8	60.6	40.9	90.9
EVR	90.9	63.6	45.45	95.45

PPV: Positive predictive value; RVR: Rapid virological response; NPV: Negative predictive value; EVR: Early virological response.

Table 6 Treatment side effects n (%)

Side effect	n = 46
Flu like symptoms	15 (32.6)
Headache	15 (32.6)
Fever	27 (58.7)
Injection site reaction	7 (15.2)
Itching	1 (2.2)
Fainting	1 (2.2)
Vomiting	6 (13)
Nervousness	1 (2.2)
Loss of appetite	10 (21.7)
Sleeplessness	1 (2.2)
Rigors	3 (6.5)
Neutropenia	6 (13)
Anemia (Hb 8.5-10 g/dL)	8 (17.4)
Anemia (Hb ≤ 8.5 g/dL)	2 (4.3)
Abdominal pain	2 (4.3)
Arthralgia	5 (10.9)
Diarrhea	4 (8.7)