Evolution of treatment-emergent resistant variants in telaprevir phase 3 clinical trials

Clinical Infectious Diseases

Volumn 57, Issue 2, 2013, Pages 221-229

  Sullivan, James C ^a   De Meyer, Sandra ^b   Bartels, Doug J ^a   Dierynck, Inge ^b   Zhang, Eileen Z ^a   Spanks, Joan ^a   Tigges, Ann M ^a   Ghys, Anne ^b   Dorrian, Jennifer ^a   Adda, Nathalie ^a   Martin, Emily C ^a   Beumont, Maria ^b   Jacobson, Ira M ^c   Sherman, Kenneth E ^d   Zeuzem, Stefan ^e   Picchio, Gaston ^f   Kieffer, Tara L ^a  

^a VERTEX PHARMACEUTICALS   (United States)

^b JANSSEN RESEARCH FOUNDATION   (Belgium)

^c WEILL CORNELL MEDICAL COLLEGE   (United States)

^d UNIVERSITY OF CINCINNATI COLLEGE OF MEDICINE   (United States)

^e UNIVERSITY HOSPITAL FRANKFURT   (Germany)

^f JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

Author keywords

clinical viral fitness; DAA; hepatitis C virus

Indexed keywords

TELAPREVIR;

ARTICLE; FOLLOW UP; HEPATITIS C; HEPATITIS C VIRUS; HUMAN; PRIORITY JOURNAL; TREATMENT DURATION; TREATMENT FAILURE;

CLINICAL VIRAL FITNESS; DAA; HEPATITIS C VIRUS;

ANTIVIRAL AGENTS; CARRIER PROTEINS; DRUG RESISTANCE, VIRAL; HEPACIVIRUS; HEPATITIS C, CHRONIC; HUMANS; MUTATION RATE; MUTATION, MISSENSE; OLIGOPEPTIDES; RETROSPECTIVE STUDIES; SEQUENCE ANALYSIS, DNA; TREATMENT FAILURE; VIRAL NONSTRUCTURAL PROTEINS;

EID: 84879683134     PISSN: 10584838     EISSN: 15376591     Source Type: Journal    
DOI: 10.1093/cid/cit226     Document Type: Article

References (17)

1. Kwong AD, Kauffman RS, Hurter P, Mueller P. Discovery and development of telaprevir: An NS3-4A protease inhibitor for treating genotype 1 chronic hepatitis C virus. Nat Biotechnol 2011; 29:993-1003.
2. Lin C, Kwong AD, Perni RB. Discovery and development of VX-950, a novel, covalent, and reversible inhibitor of hepatitis C virus NS3·4A serine protease. Infect Disord Drug Targets 2006; 6:3-16.
3. Lin K, Perni RB, Kwong AD, Lin C. VX-950, a novel hepatitis C virus (HCV) NS3-4A protease inhibitor, exhibits potent antiviral activities in HCV replicon cells. Antimicrob Agents Chemother 2006; 50:1813-22.
4. Perni RB, Almquist SJ, Byrn RA, et al. Preclinical profile of VX-950, a potent, selective, and orally bioavailable inhibitor of hepatitis C virus NS3-4A serine protease. Antimicrob Agents Chemother 2006; 50:899-909.
5. Neumann AU, Lam NP, Dahari H, et al. Hepatitis C viral dynamics in vivo and the antiviral efficacy of interferon-alpha therapy. Science 1998; 282:103-7.
6. Rong L, Dahari H, Ribeiro RM, Perelson AS. Rapid emergence of protease inhibitor resistance in hepatitis C virus. Sci Transl Med 2010; 2:30ra32.
7. INCIVEK. US Prescribing Information. Cambridge, MA: Vertex Pharmaceuticals Incorporated, 2012.
8. Kieffer TL, De MS, Bartels DJ, et al. Hepatitis C viral evolution in genotype 1 treatment-naive and treatment-experienced patients receiving telaprevir-based therapy in clinical trials. PLoS One 2012; 7:e34372.
9. Reesink HW, Zeuzem S, Weegink CJ, et al. Rapid decline of viral RNA in hepatitis C patients treated with VX-950: A phase Ib, placebocontrolled, randomized study. Gastroenterology 2006; 131:997-1002.
10. Hezode C, Forestier N, Dusheiko G, et al. Telaprevir and peginterferon with or without ribavirin for chronic HCV infection. N Engl J Med 2009; 360:1839-50.
11. Sarrazin C, Kieffer TL, Bartels D, et al. Dynamic hepatitis C virus genotypic and phenotypic changes in patients treated with the protease inhibitor telaprevir. Gastroenterology 2007; 132:1767-77.
12. Thomas XV, de Bruijne J, Sullivan JC, et al. Evaluation of persistence of resistant variants with ultra-deep pyrosequencing in chronic hepatitis C patients treated with telaprevir. PLoS One 2012; 7:e41191.
13. Jacobson IM, McHutchison JG, Dusheiko G, et al. Telaprevir for previously untreated chronic hepatitis C virus infection. N Engl J Med 2011; 364:2405-16.
14. Sherman KE, Flamm SL, Afdhal NH, et al. Response-guided telaprevir combination treatment for hepatitis C virus infection. N Engl J Med 2011; 365:1014-24.
15. Zeuzem S, Andreone P, Pol S, et al. Telaprevir for retreatment of HCV infection. N Engl J Med 2011; 364:2417-28.
16. Zhang EZ, Bartels DJ, Frantz JD, et al. Development of a sensitive RTPCR method for amplifying and sequencing near full-length HCV genotype 1 RNA from patient samples. Virol J 2013; 10:53.
17. Bartels DJ, Sullivan JC, Zhang EZ, et al. Hepatitis C virus variants with decreased sensitivity to direct-acting antivirals (DAAs) were rarely observed in DAA-naive patients prior to treatment. J Virol 2013; 87:1544-53.