A randomized trial of peginterferon α-2a with or without ribavirin for HBeAg-negative chronic hepatitis B

American Journal of Gastroenterology

Volumn 105, Issue 8, 2010, Pages 1762-1769

  Rijckborst, Vincent ^a   Ter Borg, Martijn J ^a   Cakaloglu, Yilmaz ^b   Ferenci, Peter ^c   Tabak, Fehmi ^d   Akdogan, Meral ^e   Simon, Krzysztof ^f   Raptopoulou Gigi, Maria ^g   Rmeci, Necati ^h   Zondervan, Pieter E ^a   Verhey, Elke ^a   Van Vuuren, Anneke J ^a   Hansen, Bettina E ^a   Janssen, Harry L A ^a  

^a ERASMUS MEDICAL CENTER   (Netherlands)

^b ISTANBUL UNIVERSITY   (Turkey)

^c MEDICAL UNIVERSITY OF VIENNA   (Austria)

^d ISTANBUL UNIVERSITY   (Turkey)

^e Department of Gastroenterology   (Turkey)

^f WROCLAW MEDICAL UNIVERSITY   (Poland)

^g ARISTOTLE UNIVERSITY OF THESSALONIKI   (Greece)

^h ANKARA UNIVERSITY   (Turkey)

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; HEPATITIS B(E) ANTIGEN; PEGINTERFERON ALPHA2A; PLACEBO; RIBAVIRIN; VIRUS DNA;

ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALOPECIA; ANEMIA; ANOREXIA; ARTHRALGIA; ARTICLE; ASTHENIA; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CONVULSION; COUGHING; DOUBLE BLIND PROCEDURE; DRUG WITHDRAWAL; FATIGUE; FEMALE; FEVER; FLU LIKE SYNDROME; FOLLOW UP; HEADACHE; HEMOGLOBIN BLOOD LEVEL; HEPATITIS B; HUMAN; HYPOTHYROIDISM; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; MYALGIA; NAUSEA; NEUTROPENIA; NEUTROPHIL COUNT; PRIORITY JOURNAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RELAPSE; RHEUMATOID ARTHRITIS; SIDE EFFECT; THROMBOCYTOPENIA; UNSPECIFIED SIDE EFFECT;

ADOLESCENT; ADULT; AGED; ANTIVIRAL AGENTS; CHI-SQUARE DISTRIBUTION; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; FEMALE; HEPATITIS B E ANTIGENS; HEPATITIS B SURFACE ANTIGENS; HEPATITIS B, CHRONIC; HUMANS; INTERFERON ALFA-2A; LIVER FUNCTION TESTS; MALE; MIDDLE AGED; POLYETHYLENE GLYCOLS; RIBAVIRIN; TREATMENT OUTCOME;

EID: 77955383602     PISSN: 00029270     EISSN: 15720241     Source Type: Journal    
DOI: 10.1038/ajg.2010.186     Document Type: Article

References (39)

1. Dienstag JL. Hepatitis B virus infection. N Engl J Med 2008; 359: 1486-1500
2. Hadziyannis SJ, Vassilopoulos D. Hepatitis B e antigen-negative chronichepatitis B. Hepatology (Baltimore, MD) 2001; 34: 617-624
3. Funk ML, Rosenberg DM, Lok AS. World-wide epidemiology of HBeAgnegativechronic hepatitis B and associated precore and core promotervariants. J Viral Hepatitis 2002; 9: 52-61.
4. Zarski JP, Marcellin P, Leroy V et al. Characteristics of patients with chronichepatitis B in France: predominant frequency of HBe antigen negativecases. J Hepatol 2006; 45: 355-360
5. Liaw YF, Leung N, Kao JH et al. Asian-Pacific consensus statement on themanagement of chronic hepatitis B: a 2008 update. Hepatol Int 2008; 2: 263-283
6. European Association for The Study of The L. EASL clinical practice guidelines:management of chronic hepatitis B. J Hepatol 2009; 50: 227-242
7. Lok AS, McMahon BJ. Chronic hepatitis B: update 2009. Hepatology(Baltimore, MD) 2009; 50: 661-662
8. Hadziyannis SJ, Tassopoulos NC, Heathcote EJ et al. Adefovir dipivoxil forthe treatment of hepatitis B e antigen-negative chronic hepatitis B. N Engl JMed 2003; 348: 800-807
9. Lai CL, Gane E, Liaw YF et al. Telbivudine vs. lamivudine in patients withchronic hepatitis B. N Engl J Med 2007; 357: 2576-2588
10. Lai CL, Shouval D, Lok AS et al. Entecavir vs. lamivudine for patients withHBeAg-negative chronic hepatitis B. N Engl J Med 2006; 354: 1011-1020
11. Marcellin P, Heathcote EJ, Buti M et al. Tenofovir Disoproxil Fumarate vs.Adefovir Dipivoxil for chronic hepatitis B. N Engl J Med 2008; 359: 2442-2455
12. Shouval D, Lai CL, Chang TT et al. Relapse of hepatitis B in HBeAg-negativechronic hepatitis B patients who discontinued successful entecavir treatment:the case for continuous antiviral therapy. J Hepatol 2009; 50: 289-295
13. Hadziyannis SJ, Tassopoulos NC, Heathcote EJ et al. Long-term therapywith adefovir dipivoxil for HBeAg-negative chronic hepatitis B. N Engl JMed 2005; 352: 2673-2681
14. Santantonio T, Mazzola M, Iacovazzi T et al. Long-term follow-up ofpatients with anti-HBe/HBV DNA-positive chronic hepatitis B treated for12 months with lamivudine. J Hepatol 2000; 32: 300-306
15. Fattovich G, Farci P, Rugge M et al. A randomized controlled trial of lymphoblastoidinterferon-alpha in patients with chronic hepatitis B lackingHBeAg. Hepatology (Baltimore, MD) 1992; 15: 584-589
16. Hadziyannis S, Bramou T, Makris A et al. Interferon alfa-2b treatment ofHBeAg negative/serum HBV DNA positive chronic active hepatitis typeB. J Hepatol 1990; 11 (Suppl 1): S133-6.
17. Pastore G, Santantonio T, Milella M et al. Anti-HBe-positive chronichepatitis B with HBV-DNA in the serum response to a 6-month course oflymphoblastoid interferon. J Hepatol 1992; 14: 221-225
18. Marcellin P, Lau GK, Bonino F et al. Peginterferon alfa-2a alone, lamivudinealone, and the two in combination in patients with HBeAg-negative chronichepatitis B. N Engl J Med 2004; 351: 1206-1217
19. Ning Q, Brown D, Parodo J et al. Ribavirin inhibits viral-induced macrophageproduction of TNF, IL-1, the procoagulant fgl2 prothrombinase andpreserves Th 1 cytokine production but inhibits Th 2 cytokine response.J Immunol 1998; 160: 3487-3493
20. Tam RC, Pai B, Bard J et al. Ribavirin polarizes human T cell responsestowards a Type 1 cytokine profile. J Hepatol 1999; 30: 376-382
21. Hultgren C, Milich DR, Weiland O et al. The antiviral compound ribavirinmodulates the T helper (Th) 1/Th 2 subset balance in hepatitis B and C virusspecific immune responses. J General Virol 1998; 79 (Part 10): 2381-2391
22. Rico MA, Quiroga JA, Subira D et al. Hepatitis B virus-specific T-cellproliferation and cytokine secretion in chronic hepatitis B e antibodypositivepatients treated with ribavirin and interferon alpha. Hepatology(Baltimore, MD) 2001; 33: 295-300.
23. Cotonat T, Quiroga JA, Lopez-Alcorocho JM et al. Pilot study of combinationtherapy with ribavirin and interferon alfa for the retreatment ofchronic hepatitis B e antibody-positive patients. Hepatology (Baltimore,MD) 2000; 31: 502-506
24. Liu CJ, Chuang WL, Lee CM et al. Peginterferon alfa-2a plus ribavirin forthe treatment of dual chronic infection with hepatitis B and C viruses.Gastroenterology 2009; 136: 496-504.e3.
25. Ishak K, Baptista A, Bianchi L et al. Histological grading and staging ofchronic hepatitis. J Hepatol 1995; 22: 696-699
26. Marcellin P, Piratvisuth T, Brunetto M et al. Virological and biochemicalresponse in patients with HBeAg-negative chronic hepatitis B treated withpeginterferon alfa-2a (40 KD) with or without lamivudine: results of 4-yearfollow-up. J Hepatol 2008; 48: S46.
27. Bonino F, Marcellin P, Lau GK et al. Predicting response to peginterferonalpha-2a, lamivudine and the two combined for HBeAg-negative chronichepatitis B. Gut 2007; 56: 699-705.
28. Erhardt A, Blondin D, Hauck K et al. Response to interferon alfa is hepatitisB virus genotype dependent: genotype A is more sensitive to interferonthan genotype D. Gut 2005; 54: 1009-1013
29. Janssen HL, van Zonneveld M, Senturk H et al. Pegylated interferonalfa-2b alone or in combination with lamivudine for HBeAg-positivechronic hepatitis B: a randomised trial. Lancet 2005; 365: 123-129
30. Lau GK, Piratvisuth T, Luo KX et al. Peginterferon Alfa-2a, lamivudine,and the combination for HBeAg-positive chronic hepatitis B. N Engl J Med2005; 352: 2682-2695
31. Buster EH, Hansen BE, Lau GK et al. Factors that predict response ofpatients with hepatitis B e antigen-positive chronic hepatitis B to peginterferon-alpha. Gastroenterology 2009; 137: 2002-2009
32. Fried MW, Shiffman ML, Reddy KR et al. Peginterferon alfa-2aplus ribavirin for chronic hepatitis C virus infection. N Engl J Med2002; 347: 975-982
33. Feld JJ, Hoofnagle JH. Mechanism of action of interferon and ribavirin intreatment of hepatitis C. Nature 2005; 436: 967-972
34. Liu CJ, Lai MY, Chao YC et al. Interferon alpha-2b with and without ribavirinin the treatment of hepatitis B e antigen-positive chronic hepatitis B: arandomized study. Hepatology (Baltimore, MD) 2006; 43: 742-749
35. Gish RG, Lau DT, Schmid P et al. A pilot study of extended durationpeginterferon alfa-2a for patients with hepatitis B e antigen-negativechronic hepatitis B. Am J Gastroenterol 2007; 102: 2718-2723
36. Lampertico P, Del Ninno E, Vigano M et al. Long-term suppression ofhepatitis B e antigen-negative chronic hepatitis B by 24-month interferontherapy. Hepatology (Baltimore, MD) 2003; 37: 756-763
37. Manesis EK, Hadziyannis SJ. Interferon alpha treatment and retreatmentof hepatitis B e antigen-negative chronic hepatitis B. Gastroenterology2001; 121: 101-109
38. Oliveri F, Santantonio T, Bellati G et al. Long term response to therapyof chronic anti-HBe-positive hepatitis B is poor independent of type andschedule of interferon. Am J Gastroenterol 1999; 94: 1366-1372
39. Hadziyannis SJ, Sette H Jr, Morgan TR et al. Peginterferon-alpha2a andribavirin combination therapy in chronic hepatitis C: a randomized study oftreatment duration and ribavirin dose. Ann Intern Med 2004; 140: 346-355