Safety and on-treatment efficacy of telaprevir

The early access programme for patients with advanced hepatitis C

M. Colombo, I. Fernández, D. Abdurakhmanov, P. A. Ferreira, S. I. Strasser, P. Urbanek, C. Moreno, A. Streinu-Cercel, A. Verheyen, W. Iraqi, R. Demasi, A. Hill, J. M. Läuffer, I. Lonjon-Domanec, H. Wedemeyer

Research output: Contribution to journalArticle

38 Citations (Scopus)

Abstract

Background and aim: Severe adverse events (AEs) compromise the outcome of direct antiviral agent-based treatment in patients with advanced liver fibrosis due to HCV infection. HEP3002 is an ongoing multinational programme to evaluate safety and efficacy of telaprevir (TVR) plus pegylated-interferon-α (PEG-IFNα) and ribavirin (RBV) in patients with advanced liver fibrosis caused by HCV genotype 1 (HCV-1). Methods: 1782 patients with HCV-1 and bridging fibrosis or compensated cirrhosis were prospectively recruited from 16 countries worldwide, and treated with 12 weeks of TVR plus PEG-IFN/RBV, followed by 12 or 36 weeks of PEG-IFN and RBV (PR) alone dependent on virological response to treatment and previous response type. Results: 1587 patients completed 12 weeks of triple therapy and 4 weeks of PR tail (53% cirrhosis, 22% HCV-1a). By week 12, HCV RNA was undetectable in 85% of naives, 88% of relapsers, 80% of partial responders and 72% of null responders. Overall, 931 patients (59%) developed grade 1-4 anaemia (grade 3/4 in 31%), 630 (40%) dose reduced RBV, 332 (21%) received erythropoietin and 157 (10%) were transfused. Age and female gender were the strongest predictors of anaemia. 64 patients (4%) developed a grade 3/4 rash. Discontinuation of TVR due to AEs was necessary in 193 patients (12%). Seven patients died (0.4%, six had cirrhosis). Conclusions: In compensated patients with advanced fibrosis due to HCV-1, triple therapy with TVR led to satisfactory rates of safety, tolerability and on-treatment virological response with adequate managements of AEs.

Original languageEnglish
Pages (from-to)1150-1158
Number of pages9
JournalGut
Volume63
Issue number7
DOIs
Publication statusPublished - 2014

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Hepatitis C
Safety
Ribavirin
Fibrosis
Interferons
Genotype
Liver Cirrhosis
Anemia
Therapeutics
telaprevir
Erythropoietin
Exanthema
Antiviral Agents
RNA
Infection

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Colombo, M., Fernández, I., Abdurakhmanov, D., Ferreira, P. A., Strasser, S. I., Urbanek, P., ... Wedemeyer, H. (2014). Safety and on-treatment efficacy of telaprevir: The early access programme for patients with advanced hepatitis C. Gut, 63(7), 1150-1158. https://doi.org/10.1136/gutjnl-2013-305667

Safety and on-treatment efficacy of telaprevir : The early access programme for patients with advanced hepatitis C. / Colombo, M.; Fernández, I.; Abdurakhmanov, D.; Ferreira, P. A.; Strasser, S. I.; Urbanek, P.; Moreno, C.; Streinu-Cercel, A.; Verheyen, A.; Iraqi, W.; Demasi, R.; Hill, A.; Läuffer, J. M.; Lonjon-Domanec, I.; Wedemeyer, H.

In: Gut, Vol. 63, No. 7, 2014, p. 1150-1158.

Research output: Contribution to journalArticle

Colombo, M, Fernández, I, Abdurakhmanov, D, Ferreira, PA, Strasser, SI, Urbanek, P, Moreno, C, Streinu-Cercel, A, Verheyen, A, Iraqi, W, Demasi, R, Hill, A, Läuffer, JM, Lonjon-Domanec, I & Wedemeyer, H 2014, 'Safety and on-treatment efficacy of telaprevir: The early access programme for patients with advanced hepatitis C', Gut, vol. 63, no. 7, pp. 1150-1158. https://doi.org/10.1136/gutjnl-2013-305667
Colombo, M. ; Fernández, I. ; Abdurakhmanov, D. ; Ferreira, P. A. ; Strasser, S. I. ; Urbanek, P. ; Moreno, C. ; Streinu-Cercel, A. ; Verheyen, A. ; Iraqi, W. ; Demasi, R. ; Hill, A. ; Läuffer, J. M. ; Lonjon-Domanec, I. ; Wedemeyer, H. / Safety and on-treatment efficacy of telaprevir : The early access programme for patients with advanced hepatitis C. In: Gut. 2014 ; Vol. 63, No. 7. pp. 1150-1158.
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abstract = "Background and aim: Severe adverse events (AEs) compromise the outcome of direct antiviral agent-based treatment in patients with advanced liver fibrosis due to HCV infection. HEP3002 is an ongoing multinational programme to evaluate safety and efficacy of telaprevir (TVR) plus pegylated-interferon-α (PEG-IFNα) and ribavirin (RBV) in patients with advanced liver fibrosis caused by HCV genotype 1 (HCV-1). Methods: 1782 patients with HCV-1 and bridging fibrosis or compensated cirrhosis were prospectively recruited from 16 countries worldwide, and treated with 12 weeks of TVR plus PEG-IFN/RBV, followed by 12 or 36 weeks of PEG-IFN and RBV (PR) alone dependent on virological response to treatment and previous response type. Results: 1587 patients completed 12 weeks of triple therapy and 4 weeks of PR tail (53{\%} cirrhosis, 22{\%} HCV-1a). By week 12, HCV RNA was undetectable in 85{\%} of naives, 88{\%} of relapsers, 80{\%} of partial responders and 72{\%} of null responders. Overall, 931 patients (59{\%}) developed grade 1-4 anaemia (grade 3/4 in 31{\%}), 630 (40{\%}) dose reduced RBV, 332 (21{\%}) received erythropoietin and 157 (10{\%}) were transfused. Age and female gender were the strongest predictors of anaemia. 64 patients (4{\%}) developed a grade 3/4 rash. Discontinuation of TVR due to AEs was necessary in 193 patients (12{\%}). Seven patients died (0.4{\%}, six had cirrhosis). Conclusions: In compensated patients with advanced fibrosis due to HCV-1, triple therapy with TVR led to satisfactory rates of safety, tolerability and on-treatment virological response with adequate managements of AEs.",
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T1 - Safety and on-treatment efficacy of telaprevir

T2 - The early access programme for patients with advanced hepatitis C

AU - Colombo, M.

AU - Fernández, I.

AU - Abdurakhmanov, D.

AU - Ferreira, P. A.

AU - Strasser, S. I.

AU - Urbanek, P.

AU - Moreno, C.

AU - Streinu-Cercel, A.

AU - Verheyen, A.

AU - Iraqi, W.

AU - Demasi, R.

AU - Hill, A.

AU - Läuffer, J. M.

AU - Lonjon-Domanec, I.

AU - Wedemeyer, H.

PY - 2014

Y1 - 2014

N2 - Background and aim: Severe adverse events (AEs) compromise the outcome of direct antiviral agent-based treatment in patients with advanced liver fibrosis due to HCV infection. HEP3002 is an ongoing multinational programme to evaluate safety and efficacy of telaprevir (TVR) plus pegylated-interferon-α (PEG-IFNα) and ribavirin (RBV) in patients with advanced liver fibrosis caused by HCV genotype 1 (HCV-1). Methods: 1782 patients with HCV-1 and bridging fibrosis or compensated cirrhosis were prospectively recruited from 16 countries worldwide, and treated with 12 weeks of TVR plus PEG-IFN/RBV, followed by 12 or 36 weeks of PEG-IFN and RBV (PR) alone dependent on virological response to treatment and previous response type. Results: 1587 patients completed 12 weeks of triple therapy and 4 weeks of PR tail (53% cirrhosis, 22% HCV-1a). By week 12, HCV RNA was undetectable in 85% of naives, 88% of relapsers, 80% of partial responders and 72% of null responders. Overall, 931 patients (59%) developed grade 1-4 anaemia (grade 3/4 in 31%), 630 (40%) dose reduced RBV, 332 (21%) received erythropoietin and 157 (10%) were transfused. Age and female gender were the strongest predictors of anaemia. 64 patients (4%) developed a grade 3/4 rash. Discontinuation of TVR due to AEs was necessary in 193 patients (12%). Seven patients died (0.4%, six had cirrhosis). Conclusions: In compensated patients with advanced fibrosis due to HCV-1, triple therapy with TVR led to satisfactory rates of safety, tolerability and on-treatment virological response with adequate managements of AEs.

AB - Background and aim: Severe adverse events (AEs) compromise the outcome of direct antiviral agent-based treatment in patients with advanced liver fibrosis due to HCV infection. HEP3002 is an ongoing multinational programme to evaluate safety and efficacy of telaprevir (TVR) plus pegylated-interferon-α (PEG-IFNα) and ribavirin (RBV) in patients with advanced liver fibrosis caused by HCV genotype 1 (HCV-1). Methods: 1782 patients with HCV-1 and bridging fibrosis or compensated cirrhosis were prospectively recruited from 16 countries worldwide, and treated with 12 weeks of TVR plus PEG-IFN/RBV, followed by 12 or 36 weeks of PEG-IFN and RBV (PR) alone dependent on virological response to treatment and previous response type. Results: 1587 patients completed 12 weeks of triple therapy and 4 weeks of PR tail (53% cirrhosis, 22% HCV-1a). By week 12, HCV RNA was undetectable in 85% of naives, 88% of relapsers, 80% of partial responders and 72% of null responders. Overall, 931 patients (59%) developed grade 1-4 anaemia (grade 3/4 in 31%), 630 (40%) dose reduced RBV, 332 (21%) received erythropoietin and 157 (10%) were transfused. Age and female gender were the strongest predictors of anaemia. 64 patients (4%) developed a grade 3/4 rash. Discontinuation of TVR due to AEs was necessary in 193 patients (12%). Seven patients died (0.4%, six had cirrhosis). Conclusions: In compensated patients with advanced fibrosis due to HCV-1, triple therapy with TVR led to satisfactory rates of safety, tolerability and on-treatment virological response with adequate managements of AEs.

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