Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection
John G McHutchison, Eric J Lawitz, Mitchell L Shiffman, Andrew J Muir, Greg W Galler, Jonathan McCone, Lisa M Nyberg, William M Lee, Reem H Ghalib, Eugene R Schiff, Joseph S Galati, Bruce R Bacon, Mitchell N Davis, Pabak Mukhopadhyay, Kenneth Koury, Stephanie Noviello, Lisa D Pedicone, Clifford A Brass, Janice K Albrecht, Mark S Sulkowski, IDEAL Study Team, N Afdhal, A Al-Osaimi, L Balart, M Bennett, D Bernstein, E Bini, M Black, J Bloomer, H Bonilla, T Box, T Boyer, N Brau, K Brown, R Brown, C Bruno, W Cassidy, R Chung, D Clain, J Crippin, D Dalke, C Davis, G Davis, F Felizarta, R Firpi-Morell, S Flamm, J Franco, B Freilich, A Gibas, E Godofsky, F Gordon, J Gross, S Harrison, J Herrera, S Herrine, R Herring, K-Q Hu, J Israel, I Jacobson, S Joshi, M Khalili, A Kilby, J King, P King, A Koch, E Krawitt, M Kugelmas, P Kwo, L Lambiase, E Lebovics, J Levin, R Levine, S Lidofsky, M Lucey, M Mailliard, L Marsano, P Martin, T McGarrity, D Mikolich, T Morgan, K Mullen, S Munoz, D Nelson, F Nunes, A Nyberg, S Oh, P Pandya, M P Pauly, C Peine, R Perillo, G Poleynard, F Poordad, A Post, J Poulos, D Pound, M Rabinovitz, N Ravendhran, J Ready, R Reddy, R Reindollar, A Reuben, L Rossaro, L Rothman, R Rubin, V Rustgi, M Ryan, W Schmidt, W Semon, T Sepe, K Sherman, M Sjogren, R Sjogren, C Smith, L Stein, R Strauss, M Swaim, G Szabo, J Thurn, M Tong, J Vierling, G Wu, R Yapp, Z Younes, A Zaman, John G McHutchison, Eric J Lawitz, Mitchell L Shiffman, Andrew J Muir, Greg W Galler, Jonathan McCone, Lisa M Nyberg, William M Lee, Reem H Ghalib, Eugene R Schiff, Joseph S Galati, Bruce R Bacon, Mitchell N Davis, Pabak Mukhopadhyay, Kenneth Koury, Stephanie Noviello, Lisa D Pedicone, Clifford A Brass, Janice K Albrecht, Mark S Sulkowski, IDEAL Study Team, N Afdhal, A Al-Osaimi, L Balart, M Bennett, D Bernstein, E Bini, M Black, J Bloomer, H Bonilla, T Box, T Boyer, N Brau, K Brown, R Brown, C Bruno, W Cassidy, R Chung, D Clain, J Crippin, D Dalke, C Davis, G Davis, F Felizarta, R Firpi-Morell, S Flamm, J Franco, B Freilich, A Gibas, E Godofsky, F Gordon, J Gross, S Harrison, J Herrera, S Herrine, R Herring, K-Q Hu, J Israel, I Jacobson, S Joshi, M Khalili, A Kilby, J King, P King, A Koch, E Krawitt, M Kugelmas, P Kwo, L Lambiase, E Lebovics, J Levin, R Levine, S Lidofsky, M Lucey, M Mailliard, L Marsano, P Martin, T McGarrity, D Mikolich, T Morgan, K Mullen, S Munoz, D Nelson, F Nunes, A Nyberg, S Oh, P Pandya, M P Pauly, C Peine, R Perillo, G Poleynard, F Poordad, A Post, J Poulos, D Pound, M Rabinovitz, N Ravendhran, J Ready, R Reddy, R Reindollar, A Reuben, L Rossaro, L Rothman, R Rubin, V Rustgi, M Ryan, W Schmidt, W Semon, T Sepe, K Sherman, M Sjogren, R Sjogren, C Smith, L Stein, R Strauss, M Swaim, G Szabo, J Thurn, M Tong, J Vierling, G Wu, R Yapp, Z Younes, A Zaman
Abstract
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 1 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-2b; P=0.57 for standard-dose peginterferon alfa-2b vs. peginterferon alfa-2a). 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 alfa-2b, 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-2b. (ClinicalTrials.gov number, NCT00081770.)
2009 Massachusetts Medical Society
Source: PubMed