PEG IFN alfa-2a vs. alfa-2b: And the winner is ... ?

被引:7
作者
Craxi, Antonio [1 ]
机构
[1] Univ Palermo, Med Clin, Cattedra Gastroenterol, Di Bi MIS, I-90127 Palermo, Italy
关键词
Chronic hepatitis; HCV; Head-to-head studies; Pegylated interferons; Ribavirin; CHRONIC HEPATITIS-C; PEGINTERFERON ALPHA-2B; PLUS RIBAVIRIN; RANDOMIZED-TRIAL; PREDICTORS; INFECTION; VIRUS;
D O I
10.1016/j.jhep.2009.10.020
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection. McHutchison JG, Lawitz EJ, Shiffman ML Muir AJ, Gaiter GW, McCone J, Nyberg LM, Lee WM, Ghalib RH, Schiff ER, Galati JS, Bacon BR, Davis MN, Mukhopadhyay P, Koury K, Noviello S, Pedicone LD, Brass CA, Albrecht JK, Sulkowski MS; IDEAL Study Team. N Engl J Med 2009 Aug 6;361(6):580-93. Background: Treatment guidelines recommend the use of peginterferon alfa-2b or peginterferon alfa-2a in combination with ribavirin for chronic hepatitis C virus (HCV) infection. However, these regimens have not been adequately compared. Methods: At 118 sites, patients who had HCV genotype I infection and who had not previously been treated were randomly assigned to undergo 48 weeks of treatment with one of three regimens: peginterferon alfa-2b at a standard dose of 1.5 microg per kilogram of body weight per week or a low dose of 1.0 microg per kilogram per week, plus ribavirin at a dose of 800 to 1400 mg per day, or peginterferon alfa-2a at a dose of 180 microg per week plus ribavirin at a dose of 1000 to 1200 mg per day. We compared the rate of sustained virologic response and the safety and adverse-event profiles between the peginterferon alfa-2b regimens and between the standard-dose peginterferon alfa-2b regimen and the peginterferon alfa-2a regimen. Results:Among 3070 patients, rates of sustained virologic response were similar among the regimens: 39.8% with standard-dose peginterferon alfa-2b, 38.0% with low-dose peginterferon alfa-2b, and 40.9% with peginterferon alfa-2a (P = 0.20 for standard-dose vs. low-dose peginterferon alfa-2h; P = 0.57 for standard-dose peginterferon alfa-2h vs. peginterferon alfa2a). Estimated differences in response rates were 1.8% (95% confidence interval [CI, -2.3 to 6.0) between standard-dose and low-dose peginterferon alfa-2b and -1.1% (95% CI, -5.3 to 3.0) between standard-dose peginterferon alfa-2b and peginterferon alfa-2a. Relapse rates were 23.5% (95% CI, 19.9 to 27.2) for standard-dose peginterferon alfa-2b, 20.0% (95% CI, 16.4 to 23.6) for low-dose peginterferon affa-2h, and 31.5% (95% CI, 27.9 to 35.2) for peginterferon alfa-2a. The safety profile was similar among the three groups; serious adverse events were observed in 8.6% to 11.7% of patients. Among the patients with undetectable HCV RNA levels at treatment weeks 4 and 12, a sustained virologic response was achieved in 86.2% and 78.7%, respectively. Conclusions: In patients infected with HCV genotype 1, the rates of sustained virologic response and tolerability did not differ significantly between the two available peginterferon-ribavirin regimens or between the two doses of peginterferon alfa-2h. (ClinicalTrials.gov No. NCT00081770) 2009 Massachusetts Medical Society. (C) 2009 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.
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页码:133 / 135
页数:3
相关论文
共 12 条
  • [1] ASCIONE A, 2009, GASTROENTEROLOG 1020
  • [2] Predictors of response of US veterans to treatment for the hepatitis C virus
    Backus, Lisa I.
    Boothroyd, Derek B.
    Phillips, Barbara R.
    Mole, Larry A.
    [J]. HEPATOLOGY, 2007, 46 (01) : 37 - 47
  • [3] Peginterferon alfa-2b plus ribavirin for naive patients with genotype 1 chronic hepatitis C:: a randomized controlled trial
    Bruno, S
    Cammà, C
    Di Marco, V
    Rumi, M
    Vinci, M
    Camozzi, M
    Rebucci, C
    Di Bona, D
    Colombo, M
    Craxì, A
    Mondelli, MU
    Pinzello, G
    [J]. JOURNAL OF HEPATOLOGY, 2004, 41 (03) : 474 - 481
  • [4] Predictors of svr in naive HCV G1 patients in real life practice: The probe
    Craxi, A.
    Piccinino, F.
    Alberti, A.
    Ascione, A.
    Rizzetto, M.
    Iannacone, C.
    Sarracino, M.
    [J]. JOURNAL OF HEPATOLOGY, 2008, 48 : S291 - S291
  • [5] Improved outcomes in patients with hepatitis C with difficult-to-treat characteristics:: Randomized study of higher doses of peginterferon α-2a and ribavirin
    Fried, Michel W.
    Jensen, Donald M.
    Rodriguez-Torres, Maribel
    Nyberg, Lisa M.
    Di Bisceglie, Adrian M.
    Morgan, Timothy R.
    Pockros, Paul J.
    Lin, Amy
    Cupelli, Lisa
    Duff, Frank
    Wang, Ka
    Nelson, David R.
    [J]. HEPATOLOGY, 2008, 48 (04) : 1033 - 1043
  • [6] Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection.
    Fried, MW
    Shiffman, ML
    Reddy, KR
    Smith, C
    Marinos, G
    Goncales, FL
    Haussinger, D
    Diago, M
    Carosi, G
    Dhumeaux, D
    Craxi, A
    Lin, A
    Hoffman, J
    Yu, J
    [J]. NEW ENGLAND JOURNAL OF MEDICINE, 2002, 347 (13) : 975 - 982
  • [7] Peginterferon-α2a and ribavirin combination therapy in chronic hepatitis C -: A randomized study of treatment duration and ribavirin dose
    Hadziyannis, SJ
    Sette, H
    Morgan, TR
    Balan, V
    Diago, M
    Marcellin, P
    Ramadori, G
    Bodenheimer, H
    Bernstein, D
    Rizzetto, M
    Zeuzem, S
    Pockros, PJ
    Lin, A
    Ackrill, AM
    [J]. ANNALS OF INTERNAL MEDICINE, 2004, 140 (05) : 346 - 355
  • [8] Peginterferon alfa-2b and weight-based or flat-dose ribavirin in chronic hepatitis C patients: A randomized trial
    Jacobson, Ira M.
    Brown, Robert S., Jr.
    Freilich, Bradley
    Afdhal, Nezam
    Kwo, Paul Y.
    Santoro, John
    Becker, Scott
    Wakil, Adil E.
    Pound, David
    Godofsky, Eliot
    Strauss, Robert
    Bernstein, David
    Flamm, Steven
    Pauly, Mary Pat
    Mukhopadhyay, Pabak
    Griffel, Louis H.
    Brass, Clifford A.
    [J]. HEPATOLOGY, 2007, 46 (04) : 971 - 981
  • [9] Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial
    Manns, MP
    McHutchison, JG
    Gordon, SC
    Rustgi, VK
    Shiffman, M
    Reindollar, R
    Goodman, ZD
    Koury, K
    Ling, MH
    Albrecht, JK
    [J]. LANCET, 2001, 358 (9286) : 958 - 965
  • [10] Peginterferon Alfa-2b or Alfa-2a with Ribavirin for Treatment of Hepatitis C Infection
    McHutchison, John G.
    Lawitz, Eric J.
    Shiffman, Mitchell L.
    Muir, Andrew J.
    Galler, Greg W.
    McCone, Jonathan
    Nyberg, Lisa M.
    Lee, William M.
    Ghalib, Reem H.
    Schiff, Eugene R.
    Galati, Joseph S.
    Bacon, Bruce R.
    Davis, Mitchell N.
    Mukhopadhyay, Pabak
    Koury, Kenneth
    Noviello, Stephanie
    Pedicone, Lisa D.
    Brass, Clifford A.
    Albrecht, Janice K.
    Sulkowski, Mark S.
    [J]. NEW ENGLAND JOURNAL OF MEDICINE, 2009, 361 (06) : 580 - 593