Comparative Antiviral Efficacy of Generic Sofosbuvir versus Brand Name Sofosbuvir with Ribavirin for the Treatment of Hepatitis C

Table 1

Patient characteristics.

Characteristic; N (%)		Generic sofosbuvir		SOVALDI		P (generic versus SOVALDI)
		All patients; N=29	Patients with SVR data; N=25	All patients; N=37	Patients with SVR data; N=31	All patients	Patients with SVR data
Male		13 (44.8)	12 (48)	17 (45.9)	13 (41.9)	1	0.79
Age (years) ± SD		56.86± 11.58	56.28± 12.12	52.22± 11.02	51.77± 10.79	0.1	0.2
Generic sofosbuvir
Hepcivir		9 (31)	7 (28)
Hepcinate		9 (31)	9 (36)
Resof		2 (6.9)	0
Viroclear		1 (3.4)	1 (4)
Sofocure		7 (24.1)	7 (28)
Myhep		1 (3.4)	1 (4)
Fibrosis stage
Non-cirrhotic		9 (31)	8 (32)	12 (32.4)	11 (35.5)	1	1
Cirrhosis
Compensated		15 (51.7)	13 (52)	10 (27)	9 (29)
Decompensated		5 (17.2)	4 (16)	15 (40.5)	11 (35.5)
Treatment experienced (interferon/RBV)		5 (17.2)	5 (20)	8 (21.6)	5 (16.1)	0.78	0.73
Genotype
1
Unsubtyped		0	0	3 (8.1)	3 (9.7)
1a		0	0	1 (2.7)	1 (3.2)
1b		2 (6.9)	1 (4)	7 (18.9)	7 (22.6)
1c		0	0	1 (2.7)	1 (3.2)
3
Unsubtyped		15 (51.7)	14 (56)	21 (56.8)	16 (51.6)
3a		7 (24.1)	6 (24)	2 (5.4)	1 (3.2)
3i		4 (13.8)	3 (12)	0	0
4
Unsubtyped		0	0	1 (2.7)	1 (3.2)
4c		0	0	1 (2.7)	1 (3.2)
6q		1 (3.4)	1 (4)	0	0
Baseline CPS	Mean	5.72	5.48	6	5.9	0.39	0.21
EOT CPS	Mean	5.86	5.58	5.84	5.61	0.94	0.85
Baseline MELD	Mean	8.7	8.5	9.1	9	0.51	0.57
	<10	21 (72.4)	19 (76)	25 (67.6)	22 (71)
	10-19	8 (27.6)	6 (24)	11 (29.7)	8 (25.8)
	20-29	0	0	1 (2.7)	1 (3.2)
EOT MELD	Mean	9.9	9.3	9.2	9	0.4	0.74
	<10	17 (58.6)	17 (68)	25 (67.6)	22 (71)
	10-19	12 (41.4)	8 (32)	11 (29.7)	8 (25.8)
	20-29	0	0	1 (2.7)	1 (3.2)
Cirrhotics only	Mean baseline CPS	5.95	5.65	6.48	5.9	0.22	0.52
	Mean EOT CPS	6.1	5.77	6.24	5.61	0.75	0.65
	Mean baseline MELD	9	8.77	10.12	9	0.26	0.8
	Mean EOT MELD	10.65	10.12	10.32	9	0.75	0.25
Mean baseline HCV RNA (IU/ml) ± SD		3.07 x 10^6 ± 6.69 x 10^6	3.38 x 10^6 ± 7.68 x 10^6	1.02 x 10^7 ± 2.38 x 10^7	1.34 x 10^7 ± 2.97 x 10^7	0.72	0.13
Completed treatment		27	23	33	31	0.69	0.44
Mean baseline hemoglobin		12.83 ± 1.75	13.1 ± 1.73	12.44 ± 1.91	12.42 ± 1.76	0.39	0.19
Mean decrease in hemoglobin (g/dl) ± SD		2.78 ± 1.31	3.03 ±; 1.81	2.99 ± 1.67	2.94 ± 1.35	0.62	0.86
Mean duration of therapy (days)		166.1 ± 22.13	165.8 ± 22.03	146.3 ± 38.3	155.2 ± 23.96	0.016	0.093
Sustained Virologic Response		21(72.4)	21 (84)	28 (75.6)	28 (90.3)	0.59	0.69
Treatment failure		8 (27.6)	4 (16)	9 (24.3)	3 (9.7)
Week 4 on-treatment undetectable or below lower limit of detection		26 (89.7)	- -	34 (91.9)	- -	1	- -

Includes patients with missing sustained virologic response data (4 and 6 from the generic and SOVALDI cohorts respectively); one patient from the generic cohort discontinued treatment early (65 days), undergoing liver transplant at that time. This patient achieved sustained virologic response. Estimated 3-month mortality based on MELD scores [18]: 9 or less, 1.9%; 10-19, 6%; 20-29, 19.6%; 30-39, 52.6%; 40, 71.3%.
SVR: sustained virologic response; RBV: ribavirin; CPS: Child-Pugh score; EOT: end of treatment; MELD: Model for End Stage Liver Disease; HCV RNA: hepatitis C ribonucleic acid.