Boceprevir or telaprevir in hepatitis C virus chronic infection: The Italian real life experience

Table 1 Baseline characteristics of 834 patients enrolled

Age	Median 57 (range 18-78); age > 65: 18.3%
Sex	Male 64%, female 36%
BMI	Mean 25.6 (± SD) = 3.2 (range 16-39)
Genotype (%)
1a	19.2
1b	79.4
1	1.4
HCV-RNA
HCV-RNA ≤ 106	42%
HCV-RNA > 106	58%
IL 28B (%)1
TT	21.1
CT	65.4
CC	13.5
Fibrosis (%)
F1	7.7
F2	21.1
F3	33
F4	38.2
Cirrhosis (CTP%)
A5	70.8
A6	23.1
B7	4.5
B8	1.6
Previous treatment (%)
Naive	24.4
Relapser	30.5
Partial responder	14.8
Null responder	30.3
Comorbidity (%)
Diabetes mellitus	11.5
Alcohol	12.1

¹Available on 513 patients (61.5%). BMI: Body mass index; HCV: Hepatitis C virus; IL: Interleukin; CTP: Child-Turcotte-Pugh classification; SD: Standard deviation.

Table 2 Percentage of sustained virological response according to demographics and clinical characteristics

RVR1	66.5%
HCV-RNA negative at EOT	70.1%
Relapse2	7.3%
SVR 123	62.7%
Age
< 50 yr	67.4%
50-65 yr	63.1%
> 65 yr	55.3%
Previous treatment
Naive	65.7%
Relapser	73.7%
Partial responder	67.2%
Null responder	55.1%
Fibrosis (%)
F1	72.7%
F2	73.4%
F3	63.3%
F4	53.4%
F4 > 65 yr	43.8%

¹HCV-RNA negative at week 4;

²Those who achieved EOT but had HCV-RNA positive at week 12;

³HCV-RNA negative 12 wk after the EOT. RVR: Rapid virological response; EOT: End of treatment; SVR: Sustained virological response; HCV: Hepatitis C virus.

Table 3 Adverse events (%) and treatment discontinuation

Adverse events (73.9%)
Anemia	52.9
Asthenia	39.6
Neutro/thrombopenia	29.6
Dysgeusia	8.6
Psychiatric disorders	6.7
Anorectal symptoms	5.9
Others (see text)	14.9
Treatment discontinuation (122 cases; 14.6%)	Number of cases
Rash/Itch	36 (29.5%)
Anemia	28 (22.9%)
Asthenia	18 (14.7%)
Psychiatric disorders	6 (5%)
Pancytopenia	3 (2.5%)
Neutro/thrombopenia	3 (2.5%)
Others (see text)	28 (22.9%)