Boceprevir early-access for advanced-fibrosis/cirrhosis in Asia-pacific hepatitis C virus genotype 1 non-responders/relapsers

Table 1 Baseline characteristics of all study patients divided by sustained virological response status n (%)

	SVR12(+) (n = 91)	SVR12(-) (n = 55)	P value	Total1 (n = 146)
Male gender	69 (75.8)	42 (76.4)	0.941	114 (76.0)
Asians	51 (56.0)	31 (56.4)	0.970	86 (57.3)
Caucasians	40 (43.9)	23 (41.8)	0.800	63 (42.0)
Relapsers	62 (68.3)	17 (30.9)	< 0.001	80 (53.3)
Non-responders	18 (19.8)	32 (58.2)	< 0.001	53 (35.3)
Cirrhosis	44 (48.4)	23 (41.8)	0.463	69 (46.0)
IL28B-CC genotype	37 (40.7)	9 (14.5)	0.001	46 (30.7)
IL28B-Non-CC genotype	27 (29.7)	21 (38.2)	0.289	48 (32.0)
Age	52.4 (50.7-54.2)	52.7 (48.6-56.7)	0.636	52.7 (51.1-54.4)
BMI	26.4 (25.0-27.7)	24.6 (22.9-26.3)	0.735	26.1 (24.9-27.4)
Albumin (g/L)	44.4 (42.9-45.7)	44.8 (42.9-45.8)	0.142	44.2 (42.9-45.5)
Total Bilirubin (μmol/dL)	14.2 (10.7-17.7)	10.8 (8.4-13.1)	0.704	13.3 (10.9-15.7)
ALT (U/L)	86.7 (65.2-108.1)	72.4 (47.0-97.9)	0.061	81 (65.4-96.7)
INR	1.03 (1.01-1.06)	1.03 (0.99-1.07)	0.752	1.04 (1.02-1.06)
HCVRNA(× 106 IU/mL)	6.2 (3.9-8.4)	4.5 (1.9-7.1)	0.425	5.5 (3.8-7.1)
Hb (g/L)	14.7 (14.3-15.1)	14.4 (13.5-15.3)	0.743	14.6 (14.2-14.9)
WBC (× 109/L)	7.04 (6.2-7.9)	6.9 (6.02-7.9)	0.839	6.9 (6.4-7.6)
Neutrophil (× 109/L)	3.8 (3.2-4.4)	3.4 (2.9-3.9)	0.922	3.7 (3.2-4.1)
Platelets (× 109/L)	171.2 (149.5-192.9)	195.3 (163.8-226.7)	0.425	177.2 (159.9-194.6)

¹Four patients did not have an HCV RNA test for sustained virological response (SVR) at follow-up week 12, hence could not be classified. Categorical variables are shown as number (%), and continuous data are shown as means (95%CI). Alb: Serum albumin; ALT: Serum alanine aminotransferase; AST: Serum aspartate aminotransferase; LDH: Lactate dehydrogenase; RNA: HCV RNA; HCV: Hepatitis C virus.

Table 2 Serious adverse events, adverse events and discontinuations n (%)

	Asian n = 86	Caucasian n = 63	P-value	Total1n = 150
SAEs	15 (17.4)	13 (20.6)	0.613	28 (18.6)
Death	0 (0)	0 (0)	NA	0 (0)
Sepsis	0 (0)	3 (4.8)	0.038	3 (2)
Decompensation	1 (1.2)	3 (4.8)	0.168	4 (2.6)
Blood transfusions	16 (18.6)	5 (7.9)	0.076	21 (14)
AEs
Anemia (< 10 g/dL)	40 (46.5)	38 (60.3)	0.088	78 (52)
Anemia (< 8 g/dL)	14 (16.3)	11 (17.5)	0.839	25 (16.7)
Neutropenia (< 500 cells/dL)	1 (1.2)	7 (11.1)	0.008	8 (5.3)
Neutropenia (< 100 cells/dL)	12 (13.9)	10 (15.9)	0.736	22 (14.7)
Thrombocytopenia (< 30000/dL)	2 (2.3)	5 (7.9)	0.108	7 (4.7)
Skin Rash	8 (9.3)	19 (30.2)	0.001	27 (18)
Weight loss	25 (29.1)	30 (47.6)	0.003	55 (36.7)
Dysgusia	21 (24.4)	48 (76.2)	< 0.0001	69 (46)
Diarrhea	1 (1.2)	5 (7.9)	0.037	6 (4)
Nausea	9 (10.5)	12 (19.0)	0.134	21 (14)
Discontinuations	19 (22)	26 (41)	0.023	46 (30.6)
Due to AEs	4 (4.6)	9 (14.2)	0.052	13 (8.6)
Fulfilled stopping rules	15 (17.4)	12 (19)	0.175	28 (18.6)
Others	0 (0)	5 (7.9)	0.033	5 (3.3)

¹One patient had missing data on ethnic background and hence could not be classified as Asian or Caucasian. The rate of serious adverse events (SAE), adverse events (AE) and discontinuations comparing Asians with Caucasians. Univariate analysis shows significant differences between Asians and Caucasians.