Albinterferon alfa-2b was not inferior to pegylated interferon-α in a randomized trial of patients with chronic hepatitis c virus genotype 2 or 3

Gastroenterology

Volumn 139, Issue 4, 2010, Pages

  Nelson, David R ^a   Benhamou, Yves ^b   Chuang, Wanlong ^c   Lawitz, Eric J ^d   Rodrigueztorres, Maribel ^e   Flisiak, Robert ^f   Rasenack, Jens W F ^g   Kryczka, Wiesaw ^h   Lee, Chuanmo ⁱ   Bain, Vincent G ^j   Pianko, Stephen ^k   Patel, Keyur ^l   Cronin, Patrick W ^m   Pulkstenis, Erik ^m   Subramanian, G Mani ^m   McHutchison, John G ^l  

^a UNIVERSITY OF FLORIDA COLLEGE OF MEDICINE   (United States)

^b PITIÉ SALPÊTRIÈRE HOSPITAL   (France)

^c KAOHSIUNG MEDICAL UNIVERSITY HOSPITAL   (Taiwan)

^d Alamo Medical Research   (United States)

^e Fundacin de Investigacin de Diego   (Portugal)

^f Wojewdzki Szpital Specjalistyczny   (Poland)

^g UNIVERSITY OF FREIBURG   (Germany)

^h Wojewodzki Szpital Zespolony   (Poland)

ⁱ CHANG GUNG UNIVERSITY   (Taiwan)

^j UNIVERSITY OF ALBERTA   (Canada)

^k MONASH MEDICAL CENTRE   (Australia)

^l DUKE CLINICAL RESEARCH INSTITUTE   (United States)

^m GLAXOSMITHKLINE   (United States)

more..

Author keywords

ACHIEVE; AlbIFN; Pegylated Interferon ; Sustained Virologic Response

Indexed keywords

ALBINTERFERON ALPHA2B; PEGINTERFERON; PEGYLATED INTERFERON ALPHA 2A; RIBAVIRIN; UNCLASSIFIED DRUG; ALBUMINOID; ALPHA INTERFERON; ALPHA2A INTERFERON; ALPHA2B INTERFERON; ANTIVIRUS AGENT; MACROGOL DERIVATIVE; PEGINTERFERON ALPHA2A; RECOMBINANT PROTEIN;

ADULT; ALOPECIA; ANOREXIA; ANXIETY; APPETITE; ARTHRALGIA; ARTICLE; ASTHENIA; BACKACHE; CHILL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COUGHING; DEPRESSION; DIARRHEA; DIZZINESS; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; DRY SKIN; DYSPNEA; FATIGUE; FEVER; GENOTYPE; HEADACHE; HEMOGLOBIN BLOOD LEVEL; HEPATITIS C; HEPATITIS C VIRUS; HUMAN; INFLUENZA; INJECTION SITE ERYTHEMA; INSOMNIA; MAJOR CLINICAL STUDY; MOOD CHANGE; MYALGIA; NAUSEA; NEUTROPHIL COUNT; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RASH; RECOMMENDED DRUG DOSE; SIDE EFFECT; THROMBOCYTE COUNT; TREATMENT RESPONSE; TREATMENT WITHDRAWAL; VIRUS GENE; VOMITING; WEIGHT; XEROSTOMIA; AGED; CLASSIFICATION; DRUG COMBINATION; FEMALE; GENETICS; HEPACIVIRUS; HEPATITIS C, CHRONIC; MALE; MIDDLE AGED; VIROLOGY;

ADULT; AGED; ALBUMINS; ANTIVIRAL AGENTS; DRUG THERAPY, COMBINATION; FEMALE; GENOTYPE; HEPACIVIRUS; HEPATITIS C, CHRONIC; HUMANS; INTERFERON-ALPHA; MALE; MIDDLE AGED; POLYETHYLENE GLYCOLS; RECOMBINANT PROTEINS; RIBAVIRIN;

EID: 77957347542     PISSN: 00165085     EISSN: None     Source Type: Journal    
DOI: 10.1053/j.gastro.2010.06.062     Document Type: Article

References (30)

1. D. Lavanchy The global burden of hepatitis C Liver Int 29 Suppl 1 2009 74 81
2. C.W. Shepard, L. Finelli, and M.J. Alter Global epidemiology of hepatitis C virus infection Lancet Infect Dis 5 2005 558 567
3. C.M. Lee, S.N. Lu, and C.H. Hung Hepatitis C virus genotypes in southern Taiwan: prevalence and clinical implications Trans R Soc Trop Med Hyg 100 2006 767 774
4. S. Narahari, A. Juwle, and S. Basak Prevalence and geographic distribution of hepatitis C virus genotypes in Indian patient cohort Infect Genet Evol 9 2009 643 645
5. M.W. Fried, M.L. Shiffman, and K.R. Reddy Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection N Engl J Med 347 2002 975 982
6. S.J. Hadziyannis, H. Sette Jr, and T.R. Morgan Peginterferon alpha2a and ribavirin combination therapy in chronic hepatitis Ca randomized study of treatment duration and ribavirin dose Ann Intern Med 140 2004 346 355
7. M.P. Manns, J.G. McHutchison, and S.C. Gordon 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
8. M.L. Shiffman, F. Suter, and B.R. Bacon Peginterferon alfa-2a and ribavirin for 16 or 24 weeks in HCV genotype 2 or 3 N Engl J Med 357 2007 124 134
9. V. Clark, and D.R. Nelson Novel interferons for treatment of hepatitis C virus Clin Liver Dis 13 2009 351 363
10. G.M. Subramanian, M. Fiscella, and A. Lamous-Smith Albinterferon α-2b: a genetic fusion protein for the treatment of chronic hepatitis C Nat Biotechnol 25 2007 1411 1419
11. V.G. Bain, K.D. Kaita, and E.M. Yoshida A phase 2 study to evaluate the antiviral activity, safety, and pharmacokinetics of recombinant human albumin-interferon alfa fusion protein in genotype 1 chronic hepatitis C patients J Hepatol 44 2006 671 678
12. V. Balan, D.R. Nelson, and M.S. Sulkowski A phase I/II study evaluating escalating doses of recombinant human albumin-interferon-alpha fusion protein in chronic hepatitis C patients who have failed previous interferon-alpha-based therapy Antivir Ther 11 2006 35 45
13. S. Zeuzem, E.M. Yoshida, and Y. Benhamou Albinterferon alfa-2b dosed every two or four weeks in interferon-naive patients with genotype 1 chronic hepatitis C Hepatology 48 2008 407 417
14. P. Bedossa, and T. Poynard An algorithm for the grading of activity in chronic hepatitis C The METAVIR Cooperative Study Group Hepatology 24 1996 289 293
15. E.M. Brunt, C.G. Janney, and A.M. Di Bisceglie Nonalcoholic steatohepatitis: a proposal for grading and staging the histological lesions Am J Gastroenterol 94 1999 2468 2474
16. D.R. Matthews, J.P. Hosker, and A.S. Rudenski Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man Diabetologia 28 1985 412 419
17. S. Zeuzem, R. Hultcrantz, and M. Bourliere Peginterferon alfa-2b plus ribavirin for treatment of chronic hepatitis C in previously untreated patients infected with HCV genotypes 2 or 3 J Hepatol 40 2004 993 999
18. Y. Hochberg A sharper Bonferroni procedure for multiple tests of significance Biometrika 75 1988 800 802
19. W. Wang, I. Mehrota, and S. Chan Statistical considerations for noninferiority/equivalence trials in vaccine development J Biopharm Stat 16 2006 429 441
20. A. Mangia, R. Santoro, and N. Minerva Peginterferon alfa-2b and ribavirin for 12 vs 24 weeks in HCV genotype 2 or 3 N Engl J Med 352 2005 2609 2617
21. M. von Wagner, M. Huber, and T. Berg Peginterferon-alpha-2a (40KD) and ribavirin for 16 or 24 weeks in patients with genotype 2 or 3 chronic hepatitis C Gastroenterology 129 2005 522 527
22. A. Sood, V. Midha, and S. Hissar Comparison of low-dose pegylated interferon versus standard high-dose pegylated interferon in combination with ribavirin in subjects with chronic hepatitis C with genotype 3: an Indian experience J Gastroenterol Hepatol 23 2008 203 207
23. M.L. Yu, C.Y. Dai, and J.F. Huang A randomized study of peginterferon and ribavirin for 16 versus 24 weeks in subjects with genotype 2 chronic hepatitis C Gut 56 2007 553 559
24. D. Ge, J. Fellay, and A.J. Thompson Genetic variation in IL28B predicts hepatitis C treatment-induced viral clearance Nature 461 2009 399 401
25. M. Sarasin-Filipowicz, E.J. Oakeley, and F.H. Duong Interferon signaling and treatment outcome in chronic hepatitis C Proc Natl Acad Sci U S A 105 2008 7034 7039
26. D.L. Thomas, C.L. Thio, and M.P. Martin Genetic variation in IL28B and spontaneous clearance of hepatitis C virus Nature 461 2009 798 801
27. J. Moorman, M. Saad, and S. Kosseifi Hepatitis C virus and the lung: implications for therapy Chest 128 2005 2882 2892
28. ® (peginterferon alfa-2a) Summary of Product Characteristics 2009 Roche Registration Limited Welwyn Garden City, United Kingdom
29. ® (peginterferon alfa-2a) US package insert 2009 Hoffman-LaRoche Nutley, NJ
30. P. Spagnolo, S. Zeuzem, and L. Richeldi The complex interrelationships between chronic lung and liver disease: a review J Viral Hepat 17 2010 381 390