Document Detail

Efficacy of re-treatment with TMC435 as combination therapy in hepatitis C virus-infected patients following TMC435 monotherapy.
MedLine Citation:
PMID:  22885330     Owner:  NLM     Status:  MEDLINE    
In the TMC435-C101 study, 6 patients infected with hepatitis C virus genotype 1 were treated with the protease inhibitor TMC435 (200 mg once daily) as monotherapy for 5 days. Approximately 1.5 years later, 5 of these patients were re-treated with TMC435 (200 mg once daily) plus pegylated interferon alfa-2a and ribavirin (PegIFNα-2a and RBV) for 4 weeks, followed by PegIFNα-2a and RBV until week 48 (in the Optimal Protease inhibitor Enhancement of Response to therApy [OPERA-1] study). TMC435-resistant variants, which emerged in all 5 patients during the TMC435-C101 study, were no longer detected at the beginning of the OPERA-1 study based on virus population sequencing. During the OPERA-1 study, 3 patients had a sustained virologic response; deep sequencing indicated low-level persistence of resistant variants in the remaining 2 patients, which might have affected their response to re-treatment.
Oliver Lenz; Joep de Bruijne; Leen Vijgen; Thierry Verbinnen; Christine Weegink; Herwig Van Marck; Ina Vandenbroucke; Monika Peeters; Kenneth Simmen; Greg Fanning; Rene Verloes; Gaston Picchio; Hendrik Reesink
Publication Detail:
Type:  Clinical Trial; Journal Article; Research Support, Non-U.S. Gov't     Date:  2012-08-08
Journal Detail:
Title:  Gastroenterology     Volume:  143     ISSN:  1528-0012     ISO Abbreviation:  Gastroenterology     Publication Date:  2012 Nov 
Date Detail:
Created Date:  2012-10-24     Completed Date:  2013-01-14     Revised Date:  2013-11-27    
Medline Journal Info:
Nlm Unique ID:  0374630     Medline TA:  Gastroenterology     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1176-8.e1-6     Citation Subset:  AIM; IM    
Copyright Information:
Copyright © 2012 AGA Institute. Published by Elsevier Inc. All rights reserved.
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MeSH Terms
Antiviral Agents / therapeutic use
Drug Resistance, Viral
Drug Therapy, Combination
Hepacivirus / genetics*
Hepatitis C / blood,  drug therapy*,  virology
Heterocyclic Compounds, 3-Ring / therapeutic use*
Interferon-alpha / therapeutic use
Polyethylene Glycols / therapeutic use
Protease Inhibitors / therapeutic use*
RNA, Viral / blood*,  drug effects
Recombinant Proteins / therapeutic use
Ribavirin / therapeutic use
Sulfonamides / therapeutic use*
Viral Load
Reg. No./Substance:
0/Antiviral Agents; 0/Heterocyclic Compounds, 3-Ring; 0/Interferon-alpha; 0/Polyethylene Glycols; 0/Protease Inhibitors; 0/RNA, Viral; 0/Recombinant Proteins; 0/Sulfonamides; 0/peginterferon alfa-2a; 49717AWG6K/Ribavirin; 9WS5RD66HZ/simeprevir

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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