Generic vs brand forms of direct acting antivirals for hepatitis C virus treatment in Egyptian children

Table 1 Demographic data of children receiving generic vs branded direct acting antivirals, n (%)

Variable	Patients who received Ledisbuvir (n = 43)	Patients who received Harvoni® (n = 73)	P value
Age (year), mean ± SD	12.2 ± 2.5	13.4 ± 2	0.005
Range	7-18	8-18
Sex			1.0
Male	26 (60.5)	41 (56.2)
Female	17 (39.5)	32 (43.8)
Risk factors for HCV acquisition
Maternal HCV	4 (9.3)	26 (35.6)	0.002
Intrafamilial cases	12 (27.9)	29 (39.7)	0.2
Blood products transfusion	32 (74.4)	29 (39.7)	< 0.001
Hospitalization	40 (93)	51 (69.9)	0.004
Previous operations	25 (58.1)	39 (53.4)	0.7
Dental procedure	18 (41.9)	29 (39.7)	0.8
Associated co-morbidities			< 0.001
No	8 (18.6)	39 (53.4)
Yes	35 (81.4)	34 (46.6)

Student’s t test was used for mean (Parametric) and Pearson χ² or Fisher’s exact test for categorical variables. HCV: Hepatitis C virus.

Table 2 Baseline investigations and treatment response of children receiving generic vs branded direct acting antivirals, n (%)

Variable	Patients who received Ledisbuvir (n = 43)	Patients who received Harvoni®(n = 73)	P value
Baseline investigations
Total bilirubin (mg/dL): Median (IQR)	0.6 (0.3-0.9)	0.4 (0.3-0.5)	0.005
Direct bilirubin (mg/dL): Median (IQR)	0.1 (0.1-0.2)	0.1 (0.1-0.2)	0.4
ALT (U/L): Median (IQR)	51 (33.25-93.25)	57 (43-101)	0.4
AST (U/L): Median (IQR)	51.5 (29.75-78)	49 (36-66)	0.
AP (U/L): Median (IQR)	211 (158-294)	239 (137-302)	0.9
GGT (U/L): Median (IQR)	40 (22.5-72.5)	46 (23-87)	0.7
Albumin (gm/dL), mean ± SD	4.2 ± 0.5	4.1 ± 0.55	0.1
INR, mean ± SD	1.12 ± 0.15	1.06 ± 0.07	0.02
Creatinine: Median (IQR)	0.6 (0.5-0.87)	0.6 (0.5-0.7)	0.1
Degree of hepatic fibrosis by Fibroscan1			0.3
No/mild	32 (74.4)	59 (80.8)
Moderate/severe	11 (25.6)	13 (17.8)
End of treatment response	43 (100)	73 (100)	NA
End of treatment investigations
Total bilirubin (mg/dL): Median (IQR)	0.45 (0.3-0.9)	0.4 (0.3-0.5)	0.4
Direct bilirubin (mg/dL): Median (IQR)	0.1 (0-0.2)	0.1 (0.1-0.1)	0.3
ALT (U/L): Median (IQR)	25 (15-40)	24 (18-32.5)	0.7
AST (U/L): Median (IQR)	26 (18-40)	25 (20-31)	0.7
AP (U/L): Median (IQR)	198 (149-326)	211 (142-285)	0.6
GGT (U/L): Median (IQR)	26 (19-36)	20 (13-28)	0.02
Albumin (gm/dL), mean ± SD	4.2 ± 0.5	3.8 ± 0.5	0.002
INR, mean ± SD	1.1 ± 0.2	1.08 ± 0.09	0.2
Creatinine: Median (IQR)	0.65 (0.5-1)	0.5 (0.4-0.6)	0.002
Sustained virologic response	43 (100)	73 (100)	NA

¹Fibroscan could not be performed for one patient in the Harvoni group due to marked ascites.

Student’s t test was used for mean (Parametric) and Mann-Whitney U test for median (non-parametric) and Pearson χ² or Fisher’s exact test for categorical variables. ALT: Alanine aminotransferase; AP: Alkaline phosphatase; AST: Aspartate aminotransferase; GGT: Gamma glutamyl transpeptidase; HCV: Hepatitis C virus; INR: International randomized ratio; IQR: Interquartile range; NA: Not available.

Table 3 Treatment adverse events in children receiving generic vs branded direct acting antivirals, n (%)

Adverse event	Patients who received Ledisbuvir (n = 43)	Patients who received Harvoni® (n = 73)	P value
Headache	16 (37.2)	36 (49.3)	0.2
Asthenia/fatigue	16 (37.2)	39 (53.4)	0.1
Irritability	13 (30.2)	29 (39.7)	0.3
Dizziness	7 (16.3)	26 (35.6)	0.03
Cough	14 (32.6)	20 (27.4)	0.7
Nausea	8 (18.6)	13 (17.8)	1.0
Dyspnea	7 (16.3)	13 (17.8)	1.0
Diarrhea	5 (11.6)	13 (17.8)	0.4
Insomnia	5 (11.6)	11 (15.1)	0.8

Pearson χ² or Fisher’s exact test was used for comparing proportions of adverse events.