Antiviral activity of TMC435 monotherapy in patients infected with HCV genotypes 2-6: TMC435-C202, a phase IIa, open-label study

Journal of Hepatology

Volumn 56, Issue 6, 2012, Pages 1247-1253

  Moreno, Christophe ^a   Berg, Thomas ^b   Tanwandee, Tawesak ^c   Thongsawat, Satawat ^d   Van Vlierberghe, Hans ^e   Zeuzem, Stefan ^f   Lenz, Oliver ^g   Peeters, Monika ^g   Sekar, Vanitha ^h   De Smedt, Goedele ^g  

^a ERASME HOSPITAL   (Belgium)

^b UNIVERSITY HOSPITAL LEIPZIG   (Germany)

^c MAHIDOL UNIVERSITY   (Thailand)

^d CHIANG MAI UNIVERSITY   (Thailand)

^e GHENT UNIVERSITY HOSPITAL   (Belgium)

^f UNIVERSITY HOSPITAL FRANKFURT   (Germany)

^g Tibotec   (Belgium)

^h Tibotec Inc   (United States)

Author keywords

Antiviral; Genotype; HCV; Monotherapy; TMC435

Indexed keywords

ALANINE AMINOTRANSFERASE; ALKALINE PHOSPHATASE; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; PEGINTERFERON; RIBAVIRIN; SIMEPREVIR; VIRUS RNA;

ADULT; AGED; ANOREXIA; ANTIVIRAL ACTIVITY; AREA UNDER THE CURVE; ARTICLE; BACKACHE; CLINICAL ARTICLE; DIARRHEA; DRUG SAFETY; DRUG TOLERABILITY; FATIGUE; FEMALE; FLU LIKE SYNDROME; FOLLOW UP; GENOTYPE; HEADACHE; HEPATITIS C; HUMAN; MALE; MAXIMUM PLASMA CONCENTRATION; MINIMUM INHIBITORY CONCENTRATION; MONOTHERAPY; MYALGIA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PRURITUS; SIDE EFFECT; TIME TO MAXIMUM PLASMA CONCENTRATION; TREATMENT DURATION;

ADOLESCENT; ADULT; AGED; ANTIVIRAL AGENTS; FEMALE; GENOTYPE; HEPACIVIRUS; HEPATITIS C; HETEROCYCLIC COMPOUNDS, 3-RING; HUMANS; MALE; MIDDLE AGED; SULFONAMIDES;

EID: 84861188748     PISSN: 01688278     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jhep.2011.12.033     Document Type: Article

References (40)

1. M.G. Ghany, D.B. Strader, D.L. Thomas, and L.B. Seeff Diagnosis, management, and treatment of hepatitis C: an update Hepatology 49 2009 1335 1374
2. D. Lavanchy The global burden of hepatitis C Liver Int 29 2009 74 81
3. P. Simmonds, J. Bukh, C. Combet, G. Deleage, N. Enomoto, and S. Feinstone Consensus proposals for a unified system of nomenclature of hepatitis C virus genotypes Hepatology 42 2005 962 973 (Pubitemid 41401136)
4. J. Cristina Genetic diversity and evolution of hepatitis C virus in the Latin American region J Clin Virol 34 2005 S1 S7
5. M.J. Alter, D. Kruszon-Moran, O.V. Nainan, G.M. McQuillan, F. Gao, and L.A. Moyer The prevalence of hepatitis C virus infection in the United States, 1988 through 1994 N Engl J Med 341 1999 556 562 (Pubitemid 29384163)
6. A. Djebbi, H. Triki, O. Bahri, I. Cheikh, A. Sadraoui, and A.A. Ben Genotypes of hepatitis C virus circulating in Tunisia Epidemiol Infect 130 2003 501 505 (Pubitemid 36722790)
7. S. Viazov, S. Kuzin, N. Paladi, M. Tchernovetsky, E. Isaeva, and L. Mazhul Hepatitis C virus genotypes in different regions of the former Soviet Union (Russia, Belarus, Moldova, and Uzbekistan) J Med Virol 53 1997 36 40 (Pubitemid 27395893)
8. M.L. Yu, and W.L. Chuang Treatment of chronic hepatitis C in Asia: when East meets West J Gastroenterol Hepatol 24 2009 336 345
9. F. McOmish, P.L. Yap, B.C. Dow, E.A. Follett, C. Seed, and A.J. Keller Geographical distribution of hepatitis C virus genotypes in blood donors: an international collaborative survey J Clin Microbiol 32 1994 884 892 (Pubitemid 24100056)
10. S. Ramia, and J. Eid-Fares Distribution of hepatitis C virus genotypes in the Middle East Int J Infect Dis 10 2006 272 277 (Pubitemid 43870211)
11. N.N. Zein Clinical significance of hepatitis C virus genotypes Clin Microbiol Rev 13 2000 223 235 (Pubitemid 30205426)
12. D. Candotti, J. Temple, F. Sarkodie, and J.P. Allain Frequent recovery and broad genotype 2 diversity characterize hepatitis C virus infection in Ghana, West Africa J Virol 77 2003 7914 7923 (Pubitemid 36792788)
13. A.J. Freeman, A. Zekry, L.R. Whybin, C.E. Harvey, I.A. van Beek, and S.L. de Kantzow Hepatitis C prevalence among Australian injecting drug users in the 1970s and profiles of virus genotypes in the 1970s and 1990s Med J Aust 172 2000 588 591 (Pubitemid 30438934)
14. D.G. Woodfield, M. Harness, K. Rix-Trott, F. Tsuda, H. Okamoto, and M. Mayumi Identification and genotyping of hepatitis C virus in injectable and oral drug users in New Zealand Aust N Z J Med 24 1994 47 50
15. J.M. Pawlotsky, L. Tsakiris, F. Roudot-Thoraval, C. Pellet, L. Stuyver, and J. Duval Relationship between hepatitis C virus genotypes and sources of infection in patients with chronic hepatitis C J Infect Dis 171 1995 1607 1610
16. W. Sievert, I. Altraif, H.A. Razavi, A. Abdo, E.A. Ahmed, and A. Alomair A systematic review of hepatitis C virus epidemiology in Asia, Australia and Egypt Liver Int 31 2011 61 80
17. N. Antaki, A. Craxi, S. Kamal, R. Moucari, S. Van der Merwe, and S. Haffar The neglected hepatitis C virus genotypes 4, 5 and 6: an international consensus report Liver Int 30 2010 342 355
18. M.H. Nguyen, and E.B. Keeffe Prevalence and treatment of hepatitis C virus genotypes 4, 5, and 6 Clin Gastroenterol Hepatol 3 2005 S97 S101
19. C. Frank, M.K. Mohamed, G.T. Strickland, D. Lavanchy, R.R. Arthur, and L.S. Magder The role of parenteral antischistosomal therapy in the spread of hepatitis C virus in Egypt Lancet 355 2000 887 891 (Pubitemid 30137669)
20. D.T. Chao, K. Abe, and M.H. Nguyen Systematic review: epidemiology of hepatitis C genotype 6 and its management Aliment Pharmacol Ther 34 2011 286 296
21. O.G. Pybus, E. Barnes, R. Taggart, P. Lemey, P.V. Markov, and B. Rasachak Genetic history of hepatitis C virus in East Asia J Virol 83 2009 1071 1082
22. M.P. Manns, J.G. McHutchison, S.C. Gordon, V.K. Rustgi, M. Shiffman, and R. Reindollar Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial Lancet 358 2001 958 965 (Pubitemid 32913521)
23. I.M. Jacobson, R.S. Brown Jr., B. Freilich, N. Afdhal, P.Y. Kwo, and J. Santoro Peginterferon alfa-2b and weight-based or flat-dose ribavirin in chronic hepatitis C patients: a randomized trial Hepatology 46 2007 971 981 (Pubitemid 350144761)
24. S.J. Hadziyannis, H. Sette Jr., T.R. Morgan, V. Balan, M. Diago, and P. Marcellin Peginterferon-alpha2a and ribavirin combination therapy in chronic hepatitis C: a randomized study of treatment duration and ribavirin dose Ann Intern Med 140 2004 346 355
25. M.S. Khuroo, M.S. Khuroo, and S.T. Dahab Meta-analysis: a randomized trial of peginterferon plus ribavirin for the initial treatment of chronic hepatitis C genotype 4 Aliment Pharmacol Ther 20 2004 931 938 (Pubitemid 39593273)
26. M.H. Nguyen, H.N. Trinh, R. Garcia, G. Nguyen, K.D. Lam, and E.B. Keeffe Higher rate of sustained virologic response in chronic hepatitis C genotype 6 treated with 48 weeks versus 24 weeks of peginterferon plus ribavirin Am J Gastroenterol 103 2008 1131 1135 (Pubitemid 351677993)
27. European Association for the Study of the Liver EASL Clinical Practice Guidelines: management of hepatitis C virus infection J Hepatol 55 2011 245 264
28. US Food and Drug Administration. Approval of Incivek (telaprevir), a direct acting antiviral drug (DAA) to treat hepatitis C (HCV). Available from: < http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ucm256328. htm >; [accessed 3.06.11].
29. US Food and Drug Administration. Approval of Victrelis (boceprevir), a direct acting antiviral drug (DAA) to treat hepatitis C virus (HCV). Available from: < http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ ucm255413.htm >; [accessed 3.06.11].
30. W.P. Hofmann, and S. Zeuzem A new standard of care for the treatment of chronic HCV infection Nat Rev Gastroenterol Hepatol 8 2011 257 264
31. K. Chayama, and C.N. Hayes Hepatitis C virus: how genetic variability affects pathobiology of disease J Gastroenterol Hepatol 26 2011 83 95
32. M.W. Fried, M.L. Shiffman, K.R. Reddy, C. Smith, G. Marinos, and F.L. Goncales Jr. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection N Engl J Med 347 2002 975 982
33. M.W. Fried, M. Buti, G.J. Dore, P. Ferenci, I. Jacobson, and P. Marcellin Efficacy and safety of TMC435 in combination with PegInterferon α-2a and ribavirin in treatment-naïve genotype-1 HCV patients: 24-week interim results from the PILLAR study Hepatology 52 2010 403A [abs LB-5]
34. T.I. Lin, O. Lenz, G. Fanning, T. Verbinnen, F. Delouvroy, and A. Scholliers In vitro activity and preclinical profile of TMC435350, a potent hepatitis C virus protease inhibitor Antimicrob Agents Chemother 53 2009 1377 1385
35. M. Manns, H. Reesink, T. Berg, G. Dusheiko, R. Flisiak, and P. Marcellin Rapid viral response of once-daily TMC435 plus peginterferon/ribavirin in hepatitis C genotype-1 patients: a randomized trial Antivir Ther 16 2011 1021 1033
36. Zeuzem S, Foster GR, Fried MW, Hezode C, Hirschfield G, Nikitin I, et al. The ASPIRE trial: TMC435 in treatment-experienced patients with genotype-1 HCV infection who have failed previous PEG/RBV treatment In: Annual Meeting of the European Association for the Study of the Liver, Vienna, Austria, 14-18 April, 2010 [abstract].
37. Lin TI, Devogelaere B, Lenz O, et al. Inhibitory activity of TMC435350 on HCV NS3/4A proteases from genotypes 1 to 6. Poster 1912 presented at the 59th American Association for the Study of Liver Diseases meeting, San Francisco, CA, USA, 31 October-4 November, 2008.
38. Benhamou Y, Moussalli J, Ratziu V, et al. Results of a proof of concept study (C210) of telaprevir monotherapy and in combination with peginterferon alfa-2A and ribavirin in treatment-naive genotype 4 HCV patients. Poster presented at the 44th Annual Meeting of the European Association for the Study of the Liver, Copenhagen, Denmark, 22 April, 2009.
39. Foster GR, Hezode C, Bronowicki G, et al. Activity of telaprevir alone or in combination with peginterferon alfa-2a and ribavirin in treatment-naive genotype 2 and 3 hepatitis-C patients: final results of Study C209. Poster presented at the 145th Annual Meeting of the European Association for the Study of the Liver, Vienna, Austria, 14-18 April, 2010.
40. Lenz O, Vijgen L, Moreno C, et al. Virologic response and characterization of HCV genotypes 2 to 6 under TMC435 monotherapy (study TMC435-C202). Poster 16 presented at the International Workshop on HIV and Hepatitis Virus Drug Resistance and Curative Strategies, Los Cabos, Mexico, 7-11 June, 2011.