Abstract
Background & Aims: There is little information regarding the extent to which difficult to cure patients with advanced liver fibrosis, due to hepatitis C virus genotype-1 (HCV-1) can successfully and safely be treated with triple therapy with telaprevir (TVR), pegylated interferon alpha (P) and ribavirin (R). In the TVR early access program HEP3002 we aimed to explore treatment safety and efficacy, and identify predictors of sustained virological response at week 24 (SVR24). Methods: 1078 patients with bridging fibrosis (n = 552) or cirrhosis (n = 526) diagnosed by either liver biopsy or non-invasive markers, with compensated bone marrow (neutrophils >1500/ mm3, Hb >12/13 g/dl) and liver function (Albumin >3.3 g/dl, Platelets >90,000/ml) received TVR PR for 12 weeks, followed by a PR tail according to label. Results: Overall, 614 (57%) achieved SVR24 by intention-to-treat analysis. The SVR24 rate was 68% in 221 treatment naïve patients (62.8% F4), 72% in 356 prior relapsers (64.4% F4), 55% in 139 partial responders (53.2% F4), and 34% in 294 null responders (28.6% F4). The SVR24 rate to response-guided therapy (24 weeks treatment duration if undetectable viremia at weeks 4 and 12) was 84% in 222 naïve/relapser F3 patients. Independent predictors of response were: (A) F3 (odds ratio (OR) = 1.51, 95% CI 1.31- 2.00, p = 0.005), (B) subtype 1b (OR = 1.63, 95% CI 1.18-2.24, p = 0.0029), (C) alpha-fetoprotein
| Original language | English |
|---|---|
| Pages (from-to) | 976-983 |
| Number of pages | 8 |
| Journal | Journal of Hepatology |
| Volume | 61 |
| Issue number | 5 |
| DOIs | |
| Publication status | Published - 2014 |
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Keywords
- Cirrhosis
- Hepatitis C
- Pegylated interferon
- Telaprevir
ASJC Scopus subject areas
- Hepatology
- Medicine(all)
Cite this
Sustained virological response with telaprevir in 1078 patients with advanced hepatitis C : The international telaprevir access program. / Colombo, Massimo; Strasser, Simone; Moreno, Christophe; Ferreira, Paulo Abrao; Urbanek, Petr; Fernández, Inmaculada; Abdurakmonov, Djamal; Streinu-Cercel, Adrian; Verheyen, Anke; Iraqi, Wafae; DeMasi, Ralph; Hill, Andrew; Lonjon-Domanec, Isabelle; Wedemeyer, Heiner.
In: Journal of Hepatology, Vol. 61, No. 5, 2014, p. 976-983.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Sustained virological response with telaprevir in 1078 patients with advanced hepatitis C
T2 - The international telaprevir access program
AU - Colombo, Massimo
AU - Strasser, Simone
AU - Moreno, Christophe
AU - Ferreira, Paulo Abrao
AU - Urbanek, Petr
AU - Fernández, Inmaculada
AU - Abdurakmonov, Djamal
AU - Streinu-Cercel, Adrian
AU - Verheyen, Anke
AU - Iraqi, Wafae
AU - DeMasi, Ralph
AU - Hill, Andrew
AU - Lonjon-Domanec, Isabelle
AU - Wedemeyer, Heiner
PY - 2014
Y1 - 2014
N2 - Background & Aims: There is little information regarding the extent to which difficult to cure patients with advanced liver fibrosis, due to hepatitis C virus genotype-1 (HCV-1) can successfully and safely be treated with triple therapy with telaprevir (TVR), pegylated interferon alpha (P) and ribavirin (R). In the TVR early access program HEP3002 we aimed to explore treatment safety and efficacy, and identify predictors of sustained virological response at week 24 (SVR24). Methods: 1078 patients with bridging fibrosis (n = 552) or cirrhosis (n = 526) diagnosed by either liver biopsy or non-invasive markers, with compensated bone marrow (neutrophils >1500/ mm3, Hb >12/13 g/dl) and liver function (Albumin >3.3 g/dl, Platelets >90,000/ml) received TVR PR for 12 weeks, followed by a PR tail according to label. Results: Overall, 614 (57%) achieved SVR24 by intention-to-treat analysis. The SVR24 rate was 68% in 221 treatment naïve patients (62.8% F4), 72% in 356 prior relapsers (64.4% F4), 55% in 139 partial responders (53.2% F4), and 34% in 294 null responders (28.6% F4). The SVR24 rate to response-guided therapy (24 weeks treatment duration if undetectable viremia at weeks 4 and 12) was 84% in 222 naïve/relapser F3 patients. Independent predictors of response were: (A) F3 (odds ratio (OR) = 1.51, 95% CI 1.31- 2.00, p = 0.005), (B) subtype 1b (OR = 1.63, 95% CI 1.18-2.24, p = 0.0029), (C) alpha-fetoprotein
AB - Background & Aims: There is little information regarding the extent to which difficult to cure patients with advanced liver fibrosis, due to hepatitis C virus genotype-1 (HCV-1) can successfully and safely be treated with triple therapy with telaprevir (TVR), pegylated interferon alpha (P) and ribavirin (R). In the TVR early access program HEP3002 we aimed to explore treatment safety and efficacy, and identify predictors of sustained virological response at week 24 (SVR24). Methods: 1078 patients with bridging fibrosis (n = 552) or cirrhosis (n = 526) diagnosed by either liver biopsy or non-invasive markers, with compensated bone marrow (neutrophils >1500/ mm3, Hb >12/13 g/dl) and liver function (Albumin >3.3 g/dl, Platelets >90,000/ml) received TVR PR for 12 weeks, followed by a PR tail according to label. Results: Overall, 614 (57%) achieved SVR24 by intention-to-treat analysis. The SVR24 rate was 68% in 221 treatment naïve patients (62.8% F4), 72% in 356 prior relapsers (64.4% F4), 55% in 139 partial responders (53.2% F4), and 34% in 294 null responders (28.6% F4). The SVR24 rate to response-guided therapy (24 weeks treatment duration if undetectable viremia at weeks 4 and 12) was 84% in 222 naïve/relapser F3 patients. Independent predictors of response were: (A) F3 (odds ratio (OR) = 1.51, 95% CI 1.31- 2.00, p = 0.005), (B) subtype 1b (OR = 1.63, 95% CI 1.18-2.24, p = 0.0029), (C) alpha-fetoprotein
KW - Cirrhosis
KW - Hepatitis C
KW - Pegylated interferon
KW - Telaprevir
UR - http://www.scopus.com/inward/record.url?scp=84932190976&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84932190976&partnerID=8YFLogxK
U2 - 10.1016/j.jhep.2014.06.005
DO - 10.1016/j.jhep.2014.06.005
M3 - Article
VL - 61
SP - 976
EP - 983
JO - Journal of Hepatology
JF - Journal of Hepatology
SN - 0168-8278
IS - 5
ER -