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Retreatment with telaprevir combination therapy in hepatitis C patients with well-characterized prior treatment response.
Muir A. J., Poordad F. F., Mchutchison J. G., Shiffman M. L., Berg T., Ferenci P., Heathcote E. J., Pawlotsky J.-M., Zeuzem S., Reesink H. W. et al
Hepatology 54, 5 (2011) 1538-46 - http://www.hal.inserm.fr/inserm-00647300
(22045671)
Retreatment with telaprevir combination therapy in hepatitis C patients with well-characterized prior treatment response.
Andrew Muir () 1, Fred Poordad2, John Mchutchison1, Mitchell Shiffman3, Thomas Berg4, Peter Ferenci5, E Jenny Heathcote6, Jean-Michel Pawlotsky7, 8, Stefan Zeuzem9, Henk Reesink10, Geoffrey Dusheiko11, Emily Martin12, Shelley George12, Robert Kauffman12, Nathalie Adda12
1 :  Division of Gastroenterology
Duke Clinical Research Institute – Duke University Medical Center
Durham, NC
États-Unis
2 :  Cedars-Sinai Medical Center
Cedars-Sinai Medical Center
Los Angeles, CA
États-Unis
3 :  The Liver Institute of Virginia
Bon Secours Health System
Newport News, VA
États-Unis
4 :  University Clinic
University Clinic, Leipzig
Allemagne
5 :  Dept of internal medicine III
Medical University of Vienna
Autriche
6 :  University of Toronto
University of Toronto
Canada
7 :  Institut Mondor de Recherche Biomédicale
INSERM : U955 – Université Paris-Est Créteil Val-de-Marne (UPEC) – IFR10
8 rue du Général Sarrail, 94010 Créteil
France
8 :  Centre National de Référence Virus des hépatites B, C et Delta
Institut National de la Transfusion Sanguine – Assistance publique - Hôpitaux de Paris (AP-HP)
France
9 :  Johann Wolfgang Goethe University Medical Center
Johann Wolfgang Goethe University Medical Center
Frankfurt am Main
Allemagne
10 :  Academic Medical Center
University of Amsterdam
Amsterdam
Pays-Bas
11 :  Center for Hepatology
Royal Free Hospital – University College School of Medicine
London
Royaume-Uni
12 :  MDG - Medicines Development Group
Vertex Pharmaceuticals
Cambridge, MA
États-Unis
Retreatment with peginterferon alpha and ribavirin (PR) offers a limited chance of sustained virologic response (SVR) in patients who did not achieve SVR with prior PR treatment. This study evaluated the safety and efficacy of telaprevir-based treatment in combination with PR in well-characterized patients who did not achieve SVR in the control arms of three Phase II clinical trials. Patients eligible to enroll in this open-label nonrandomized study either met on-treatment criteria for nonresponse or relapsed after 48 weeks of treatment in the control arm of the three Phase II PROVE studies. The initial protocol was a 24-week regimen: 12 weeks of telaprevir and PR followed by an additional 12 weeks of PR. During the study the protocol was amended to extend PR to 48 weeks for patients with previous null response. All other patients with undetectable hepatitis C virus (HCV) RNA at weeks 4 and 12 received 24 weeks of therapy. Those with detectable HCV RNA at weeks 4 or 12 received a total of 48 weeks of therapy. The overall SVR rate was 59% (69/117). SVR rates with T12PR were 37% (19/51) in prior null responders, 55% (16/29) in prior partial responders, 75% (6/8) in prior breakthroughs, and 97% (28/29) in prior relapsers. The overall relapse rate was 16% (13/83). Adverse events were similar to those in previous trials with telaprevir, with 9% of patients discontinuing due to an adverse event (most commonly rash and anemia). Conclusion: This study demonstrated the benefit of retreatment with a telaprevir-based regimen for patients with well-characterized nonresponse (null and partial) or relapse to a prior course of PR treatment. (HEPATOLOGY 2011;).
Sciences du Vivant/Biochimie, Biologie Moléculaire
Anglais
0270-9139

Articles dans des revues avec comité de lecture
10.1002/hep.24549
Hepatology (Hepatology)
Publisher Wiley-Blackwell
ISSN 0270-9139 (eISSN : 1527-3350)
internationale
11/2011
54
5
1538-46

telaprevir – hepatitis C – relapse – partial response – null response
This study was funded by Vertex Pharmaceuticals Incorporated and by Tibotec, a division of Janssen-Cilag Ltd.
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DOC
Muir_Study107_Manuscript_resubmitted_June_2011_.doc(126.5 KB)
Table_1_Study_107_for_resubmission_June_2011_.doc(72 KB)
Table_2_Study_107_for_resubmission_June_2011_.doc(81 KB)
Table_3_Study_107_for_resubmission_June_2011_.doc(71 KB)
Study_107_Fig_1.tif(1.1 MB)
PDF
Muir_Study107_Manuscript_resubmitted_June_2011_.pdf(166.3 KB)
Table_1_Study_107_for_resubmission_June_2011_.pdf(89.2 KB)
Table_2_Study_107_for_resubmission_June_2011_.pdf(52.2 KB)
Table_3_Study_107_for_resubmission_June_2011_.pdf(82.5 KB)