Boceprevir is highly effective in treatment-experienced hepatitis C virus-positive genotype-1 menopausal women

Table 1 Demographic characteristics of the 56 patients at enrollment

Variables
Mean age, mean ± SD (yr)	56.8 ± 6.1
Mean age at menopause, mean ± SD (yr)	49.3 ± 4.3
Time from menopause, mean ± SD (yr)	11.4 ± 6.1
Previous response n (%)
Relapse	29 (51.8)
Non response	23 (41.1)
Null response	4 (7.1)
Grading	5.1 ± 2.4
Staging	2.3 ± 1.3
Cirrhosis	21 (37.5)
Stiffness (kPa)	10.3 ± 7.1
BMI, mean ± SD	26.2 ± 4.0
Blood glucose, mean ± SD (mg/dL)	101 ± 22
Insulin_base (U/mL)	9.9 ± 7.9
HOMA score	2.5 ± 1.5
Blood Iron (μg/dL)	128 ± 87
Hb (g%)	13.0 ± 2.2
WBC (K/μL)	4.9 ± 1.4
Neutrophils (K/μL)	2.5 ± 0.9
Platelets (103/mm3)	206 ± 78
BUN (mg/dL)	36 ± 11
Creatinine (mg/dL)	0.7 ± 0.1
AST (IU/L)	58 ± 24
ALT (IU/L)	66 ± 27
ALP (IU/L)	95 ± 28
Gamma-GT (IU/L)	45 ± 15
HCV RNA (IU/mL, 103)	1.440 ± 1.178

BMI: Body mass index; ALT: Alanine aminotransferase; WBC: White blood cell; AST: Aspartate aminotransferase; ALP: Alkaline phosphatase.

Table 2 Univariate and multivariate analysis for factors predicting sustained virological response

Variables	Univariate analysis OR (95% CI)	P value	Multivariate analysis OR (95% CI)	P value
Age (yr)	1.006 (0.916-1.105)	0.900
Age at menopause	1.150 (0.931-1.450)	0.195
Previous response	2.662 (0.957-6.881)	0.043	2.927 (0.931-9.206)	0.066
Histological grading	0.894 (0.605-1.322)	0.576
Histological staging	0.982 (0.586-1.645)	0.946
Fibrosis	1.667 (0.528-5.265)	0.384
Liver stiffness	0.986 (0.895-1.086)	0.774
Cirrhosis	1.111 (0.155-7.974)	0.917
BMI	1.000 (0.825-1.212)	1.000
HCV RNA > 800.000 IU/mL	0.519 (0.120-2.248)	0.381
RVR	1.200 (0.070-20.429)	0.900
1 log decline at week 4	3.733 (1.676-12.658)	0.034	0.961(0.194-4.757)	0.961
RVR BOC	7.347 (2.156-25.035)	0.001	6.794 (1.596-21.644)	0.010
ALT (IU/mL)	0.996 (0.977-1.014)	0.645
Platelets (× 103/mm3)	1.000 (1.000-1.000)	0.165
HOMA	0.907 (0.533-1.544)	0.719

BMI: Body mass index; HCV: Hepatitis C virus; ALT: Alanine aminotransferase.

Table 3 Adverse events n (%)

Event
Death, n	0
Drug Discontinuation due to AE	6 (10)
Dose Modification due to AE	8 (14)
Any life-threatening adverse event, n	0
Any serious adverse event	2 (4)
Hematologic event Reduced neutrophil count < 750 per mm3 < 500 per mm3	14 (25) 8 (15)
Mean change in hemoglobin from baseline (g/dL)
At wk 12	-1.2
At wk 24	-2.2
At wk 48	-3.3
Erythropoietin use	20 (35)
Transfusion	1 (1.8)
Common adverse event
Nausea	24 (43)
Anemia	23 (41)
Dysgeusia	20 (36)
Fatigue	18 (32)
Rash	6 (11)

AE: Adverse event.