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

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.