Significance of a reduction in HCV RNA levels at 4 and 12 weeks in patients infected with HCV genotype 1b for the prediction of the outcome of combination therapy with peginterferon and ribavirin

BMC Infectious Diseases

Volumn 12, Issue , 2012, Pages

  Toyoda, Hidenori ^a   Kumada, Takashi ^a   Shimada, Noritomo ^b   Takaguchi, Koichi ^c   Ide, Tatsuya ^d   Sata, Michio ^d   Ginba, Hiroyuki ^e   Matsuyama, Kazuhiro ^e   Izumi, Namiki ^f  

^a OGAKI MUNICIPAL HOSPITAL   (Japan)

^b Shinmatsudo Central General Hospital   (Japan)

^c KAGAWA PREFECTURAL CENTRAL HOSPITAL   (Japan)

^d KURUME UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^e Roche Diagnostics Japan KK ^*  (Japan)

^f MUSASHINO RED CROSS HOSPITAL   (Japan)

Author keywords

Baseline factors; Chronic hepatitis C; Extended treatment; Four and twelve weeks; Peginterferon; Reduction in HCV RNA levels; Response guided therapy; Ribavirin

Indexed keywords

PEGINTERFERON; PEGINTERFERON ALPHA2A; PEGINTERFERON ALPHA2B; RIBAVIRIN; VIRUS RNA;

ADULT; ARTICLE; FEMALE; GENOTYPE; HEPATITIS B VIRUS; HEPATITIS C; HEPATITIS C VIRUS; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS; MAJOR CLINICAL STUDY; MALE; MIXED INFECTION; MULTICENTER STUDY; PREDICTION; REAL TIME POLYMERASE CHAIN REACTION; RECEIVER OPERATING CHARACTERISTIC; SENSITIVITY AND SPECIFICITY; TREATMENT FAILURE; TREATMENT OUTCOME; TREATMENT RESPONSE;

ANTIVIRAL AGENTS; DRUG THERAPY, COMBINATION; FEMALE; HEPACIVIRUS; HEPATITIS C; HUMANS; INTERFERON-ALPHA; MALE; POLYETHYLENE GLYCOLS; RECOMBINANT PROTEINS; RIBAVIRIN; RNA, VIRAL; TREATMENT OUTCOME;

EID: 84873629159     PISSN: None     EISSN: 14712334     Source Type: Journal    
DOI: 10.1186/1471-2334-12-324     Document Type: Article

References (33)

1. Ge D, Fellay J, Thompson AJ, Simon JS, Shianna KV, Urban TJ, Heinzen EL, Qiu P, Bertelsen AH, Muir AJ, Sulkowski M, McHutchison JG, Goldstein DB. Genetic variation in IL28B predicts hepatitis C treatment-induced viral clearance. Nature 2009, 461:399-401. 10.1038/nature08309, 19684573.
2. Suppiah V, Moldovan M, Ahlenstiel G, Berg T, Weltman M, Abate ML, Bassendine M, Spengler U, Dore GJ, Powell E, Riordan S, Sheridan D, Smedile A, Fragomeli V, Müller T, Bahlo M, Stewart GJ, Booth DR, George J. IL28B is associated with response to chronic hepatitis C interferon-alpha and ribavirin therapy. Nat Genet 2009, 41:1100-1104. 10.1038/ng.447, 19749758.
3. Tanaka Y, Nishida N, Sugiyama M, Kurosaki M, Matsuura K, Sakamoto N, Nakagawa M, Korenaga M, Hino K, Hige S, Ito Y, Mita E, Tanaka E, Mochida S, Murawaki Y, Honda M, Sakai A, Hiasa Y, Nishiguchi S, Koike A, Sakaida I, Imamura M, Ito K, Yano K, Masaki N, Sugauchi F, Izumi N, Tokunaga K, Mizokami M. Genome-wide association of IL28B with response to pegylated interferon-alpha and ribavirin therapy for chronic hepatitis C. Nat Genet 2009, 41:1105-1109. 10.1038/ng.449, 19749757.
4. McCarthy JJ, Li JH, Thompson A, Suchindran S, Lao XQ, Patel K, Tillmann HL, Muir AJ, McHutchison JG. Replicated association between an IL28B gene variant and a sustained response to pegylated interferon and ribavirin. Gastroenterology 2010, 138:2307-2314. 10.1053/j.gastro.2010.02.009, 2883666, 20176026.
5. Rauch A, Kutalik Z, Descombes P, Cai T, Di Iulio J, Mueller T, Bochud M, Battegay M, Bernasconi E, Borovicka J, Colombo S, Cerny A, Dufour JF, Furrer H, Günthard HF, Heim M, Hirschel B, Malinverni R, Moradpour D, Müllhaupt B, Witteck A, Beckmann JS, Berg T, Bergmann S, Negro F, Telenti A, Bochud PY, . Swiss Hepatitis C Cohort Study; Swiss HIV Cohort Study Genetic variation in IL28B is associated with chronic hepatitis C and treatment failure: a genome-wide association study. Gastroenterology 2010, 138:1338-1345. 10.1053/j.gastro.2009.12.056, 20060832, Swiss Hepatitis C Cohort Study; Swiss HIV Cohort Study.
6. Enomoto N, Sakuma I, Asahina Y, Kurosaki M, Murakami T, Yamamoto C, Ogura Y, Izumi N, Marumo F, Sato C. Mutations in the nonstructural protein 5A gene and response to interferon in patients with chronic hepatitis C virus 1b infection. N Engl J Med 1996, 334:77-81. 10.1056/NEJM199601113340203, 8531962.
7. Akuta N, Suzuki F, Sezaki H, Suzuki Y, Hosaka T, Someya T, Kobayashi M, Saitoh S, Watahiki S, Sato J, Matsuda M, Kobayashi M, Arase Y, Ikeda K, Kumada H. Association of amino acid substitution pattern in core protein of hepatitis C virus genotype1b high viral load and non-virological response to interferon-ribavirin combination therapy. Intervirology 2005, 48:372-380. 10.1159/000086064, 16024941.
8. Donlin MJ, Cannon NA, Yao E, Li J, Wahed A, Taylor MW, Belle SH, Di Bisceglie AM, Aurora R, Tavis JE. Pretreatment sequence diversity differences in the full-length hepatitis C virus open reading frame correlate with early response to therapy. J Virol 2007, 81:8211-8224. 10.1128/JVI.00487-07, 1951276, 17522222.
9. Maekawa S, Enomoto N. Viral factors influencing the response to the combination therapy of peginterferon plus ribavirin in chronic hepatitis C. J Gastroenterol 2009, 44:1009-1015. 10.1007/s00535-009-0126-7, 19756352.
10. Hayes NC, Kobayashi M, Akuta N, Suzuki F, Kumada H, Abe H, Miki D, Imamura M, Ochi H, Kamatani N, Nakamura Y, Chayama K. HCV substitutions and IL28B polymorphisms on outcome of peg-interferon plus ribavirin combination therapy. Gut 2011, 60:261-267. 10.1136/gut.2010.223495, 21068134.
11. Zeuzem S, Herrmann E, Lee JH, Fricke J, Neumann AU, Modi M, Colucci G, Roth WK. Viral kinetics in patients with chronic hepatitis C treated with standard or peginterferon alpha2a. Gastroenterology 2001, 120:1438-1447. 10.1053/gast.2001.24006, 11313314.
12. Buti M, Sanchez-Avila F, Lurie Y, Stalgis C, Valdes A, Martell M, Esteban R. Viral kinetics in genotype 1 chronic hepatitis C patients during therapy with 2 different doses of peginterferon alfa-2b plus ribavirin. Hepatology 2002, 35:930-936. 10.1053/jhep.2002.32150, 11915041.
13. Berg T, Sarrazin C, Herrmann E, Hinrichsen H, Gerlach T, Zachoval R, Wiedenmann B, Hopf U, Zeuzem S. Prediction of treatment outcome in patients with chronic hepatitis C: significance of baseline parameters and viral dynamics during therapy. Hepatology 2003, 37:600-609. 10.1053/jhep.2003.50106, 12601358.
14. Lee SS, Ferenci P. Optimizing outcomes in patients with hepatitis C virus genotype 1 or 4. Antiviral Res 2008, 13:S9-S16.
15. Martinez-Bauer E, Crespo J, Romero-Gomez M, Moreno-Otero R, Sola R, Tesei N, Pons F, Forns X, Sanchez-Tapias JM. Development and validation of two models for early prediction of response to therapy in genotype 1 chronic hepatitis C. Hepatology 2006, 43:72-80. 10.1002/hep.21002, 16374857.
16. Poordad F, Reddy KR, Martin P. Rapid virologic response: a new milestone in the management of chronic hepatitis C. Clin Infect Dis 2008, 46:78-84. 10.1086/523585, 18171217.
17. Martinot-Peignoux M, Maylin S, Moucari R, Ripault M-P, Boyer N, Cardoso A-C, Giuily M, Castelnau C, Pouteau M, Stern C, Auperin A, Bedossa P, Asselah T, Marcellin P. Virological response at 4 weeks to predict outcome of hepatitis C treatment with pegylated interferon and ribavirin. Antivir Ther 2009, 14:501-511.
18. de Segadas-Soares JA, Villela-Nogueira CA, Perez RM, Nabuco LC, Brandao-Mello CE, Coelho HSM. Is the rapid virologic response a positive predictive factor of sustained virologic response in all pretreatment status genotype 1 hepatitis C patients treated with peginterferon-α2b and ribavirin?. J Clin Gastroenterol 2009, 43:362-366. 10.1097/MCG.0b013e3181775e6a, 19077732.
19. Yu JW, Wang GQ, Sun LJ, Li XG, Li SC. Predictive value of rapid virological response and early virological response on sustained viroogical response in HCV patients treated with pegylated interferon α-2a and ribavirin. J Gastroenterol Hepatol 2007, 22:832-836. 10.1111/j.1440-1746.2007.04904.x, 17565637.
20. Huang C-F, Yang J-F, Huang J-F, Dai C-Y, Chiu C-F, Hou N-J, Hsieh M-Y, Lin Z-Y, Chen S-C, Hsieh M-Y, Wang L-Y, Chang W-Y, Chuang W-L, Yu M-L. Early identification of achieving a sustained virological response in chronic hepatitis C patients without a rapid virological response. J Gastroenterol Hepatol 2010, 25:758-765. 10.1111/j.1440-1746.2009.06148.x, 20492331.
21. Toyoda H, Kumada T, Kiriyama S, Tanikawa M, Hisanaga Y, Kanamori A, Tada T, Arakawa T, Fujimori M, Niinomi T, Ando N, Yasuda S, Sakai K, Kimura J. High ability to predict the treatment outcome of peginterferon and ribavirin combination therapy based on the reduction in HCV RNA levels at 4 weeks after starting therapy and amino acid substitutions in hepatitis C virus in patients infected with HCV genotype 1b. J Gastroenterol 2011, 46:501-509. 10.1007/s00535-010-0328-z, 20927636.
22. Marcellin P, Reau N, Ferenci P, Hadziyannis S, Messinger D, Tatsch F, Jensen D. Refined prediction of week 12 response and SVR based on week 4 response in HCV genotype 1 patients treated with peginterferon alfa-2a (40KD) and ribavirin. J Hepatol 2012, 56:1276-1282. 10.1016/j.jhep.2011.12.026, 22314423.
23. Toyoda H, Kumada T, Kiriyama S, Tanikawa M, Hisanaga Y, Kanamori A, Tada T, Hosokawa T, Arakawa T, Fujimori M. Outcome in partial early virologic responders to combination therapy with peginterferon and ribavirin in patients infected with hepatitis C virus genotype 1b. J Med Virol 2011, 83:101-107. 10.1002/jmv.21936, 21108345.
24. Jacobson IM, McHutchison JG, Dusheiko G, Di Bisceglie AM, Reddy KR, Bzowej NH, Marcellin P, Muir AJ, Ferenci P, Flisiak R, George J, Rizzerro M, Shouval D, Sola R, Terg RA, Yoshida EM, Adda N, Bengtsson L, Sankoh AJ, Kieffer TL, George S, Kauffman RS, Zeuzem S, . ADVANCE Study Team Telaprevir for previously untreated chronic hepatitis C virus infection. N Engl J Med 2011, 364:2405-2416. 10.1056/NEJMoa1012912, 21696307, ADVANCE Study Team.
25. Zeuzem S, Andreone P, Pol S, Lawitz E, Diago M, Roberts S, Focaccia R, Younossi Z, Foster GR, Horban A, Ferenci P, Nevens F, Mullhaupt B, Pockros P, Terg R, Shouval D, van Hoek B, Weiland O, Van Heeswijk R, De Meyer S, Luo D, Boogaerts G, Polo R, Picchio G, Beumont M, . REALIZE Study Team Telaprevir for retreatment of HCV infection. N Engl J Med 2011, 364:2417-2428. 10.1056/NEJMoa1013086, 21696308, REALIZE Study Team.
26. Poordad F, McCone J, Bacon BR, Bruno S, Manns MP, Sulkowski MS, Jacobson IM, Reddy KR, Goodman ZD, Boparai N, DiNubile MJ, Sniukiene V, Brass CA, Albrecht JK, Bronowicki JP. SPRINT-2 Investigators. Boceprevir for untreated chronic HCV genotype 1 infection. N Engl J Med 2011, 364:1195-1206. 10.1056/NEJMoa1010494, 21449783.
27. Bacon BR, Gordon SC, Lawitz E, Marcellin P, Vierling JM, Zeuzem S, Poordad F, Goodman ZD, Sings HL, Boparai N, Burroughs M, Brass CA, Albrecht JK, Esteban R. HCV RESPOND-2 Investigators. Boceprevir for previously treated chronic HCV genotype 1 infection. N Engl J Med 2011, 364:1207-1217. 10.1056/NEJMoa1009482, 3153125, 21449784.
28. Lok AS, Gardiner DF, Lawitz E, Martorell C, Everson GT, Ghalib R, Reindollar R, Rustgi V, McPhee F, Wind-Rotolo M, Persson A, Zhu K, Dimitrova DI, Eley T, Guo T, Grasela DM, Pasquinelli C. Preliminary study of two antiviral agents for hepatitis C genotype 1. N Engl J Med 2012, 366:216-224. 10.1056/NEJMoa1104430, 22256805.
29. Colucci G, Ferguson J, Harkleroad C, Lee S, Romo D, Soviero S, Thompson J, Velez M, Wang A, Miyahara Y, Young S, Sarrazin C. Improved COBAS TaqMan hepatitis C virus test (version 2.0) for use with the High Pure system: enhanced genotype inclusivity and performance characteristics in a multisite study. J Clin Microbiol 2007, 45:3595-3600. 10.1128/JCM.01320-07, 2168538, 17898157.
30. Pittaluga F, Allice T, Abate ML, Ciancio A, Cerutti F, Varetto S, Colucci G, Smedile A, Ghisetti V. Clinical evaluation of the COBAS Ampliprep/COBAS TaqMan for HCV RNA quantitation in comparison with the brancd-DNA assay. J Med Virol 2008, 80:254-260. 10.1002/jmv.21073, 18098148.
31. Ghany MG, Strader DB, Thomas DL, Seeff LB. Diagnosis, management, and treatment of hepatitis C: an update. Hepatology 2009, 49:1335-1374. 10.1002/hep.22759, 19330875.
32. Kato N, Hijikata M, Ootsuyama Y, Nakagawa M, Ohkoshi S, Sugimura T, Shimotohno K. Molecular cloning of the human hepatitis C virus genome from Japanese patients with non-A, non-B hepatitis. Proc Natl Acad Sci USA 1990, 87:9524-9528. 10.1073/pnas.87.24.9524, 55204, 2175903.
33. Tanaka Y, Nishida N, Sugiyama M, Tokunaga K, Mizokami M. λ-interferons and the single nucleotide polymorphisms: a milestone to tailor-made therapy for chronic hepatitis C. Hepatol Res 2010, 40:449-460. 10.1111/j.1872-034X.2010.00671.x, 20546329.