Viral Hepatitis

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Randomized trial comparing pegylated interferon α-2b versus pegylated interferon α-2a, both plus ribavirin, to treat chronic hepatitis C in human immunodeficiency virus patients†

  1. Montserrat Laguno1,‡,*,
  2. Carmen Cifuentes2,
  3. Javier Murillas3,
  4. Sergio Veloso4,
  5. Maria Larrousse1,
  6. Antoni Payeras2,
  7. Lucia Bonet3,
  8. Francese Vidal4,
  9. Ana Milinkovic1,
  10. Antoni Bassa2,
  11. Concha Villalonga3,
  12. Iñaki Pérez5,
  13. Cristina Tural6,
  14. Maria Martínez-Rebollar1,
  15. Marta Calvo1,
  16. Jose Luis Blanco1,
  17. Estaban Martínez1,
  18. Jose M. Sánchez-Tapias7,
  19. Jose M. Gatell1,
  20. Jose Mallolas1

Article first published online: 9 SEP 2008

DOI: 10.1002/hep.22598

Issue

Hepatology

Hepatology

Volume 49, Issue 1, pages 22–31, January 2009

Additional Information

How to Cite

Laguno, M., Cifuentes, C., Murillas, J., Veloso, S., Larrousse, M., Payeras, A., Bonet, L., Vidal, F., Milinkovic, A., Bassa, A., Villalonga, C., Pérez, I., Tural, C., Martínez-Rebollar, M., Calvo, M., Blanco, J. L., Martínez, E., Sánchez-Tapias, J. M., Gatell, J. M. and Mallolas, J. (2009), Randomized trial comparing pegylated interferon α-2b versus pegylated interferon α-2a, both plus ribavirin, to treat chronic hepatitis C in human immunodeficiency virus patients. Hepatology, 49: 22–31. doi: 10.1002/hep.22598

Author Information

  1. 1

    Infectious Diseases Service. Hospital Clínic, Barcelona, Spain

  2. 2

    Internal Medicine Service, Hospital Son Llàtzer, Palma de Mallorca, Spain

  3. 3

    Internal Medicine Service, Hospital Son Dureta, Palma de Mallorca, Spain

  4. 4

    Internal Medicine Service, Hospital Joan XXIII and Universitat Rovira i Virgili, Tarragona, Spain

  5. 5

    Biostatistics, Hospital Clínic, Barcelona

  6. 6

    Internal Medicine Service, Hospital Germans Trias i Pujol, Badalona, Spain

  7. 7

    Hepatology Service, Hospital Clínic, Barcelona, Spain

  1. ‡

    fax: (34) 3-4515424

*Infectious Diseases Unit, Hospital Clinic, Villarroel 170, 08036 Barcelona, Spain

  1. †

    Potential conflict of interest: Dr. Payeras is on the speakers' bureau of Roche and Abbott Laboratories. Dr. Mallolas is a consultant for Roche and Schering-Plough.

Publication History

  1. Issue published online: 28 DEC 2008
  2. Article first published online: 9 SEP 2008
  3. Accepted manuscript online: 9 SEP 2008 12:00AM EST
  4. Manuscript Accepted: 21 AUG 2008
  5. Manuscript Received: 4 JUL 2008

Funded by

  • Spanish Ministry of Health. Grant Number: FIS 2007
  • “Institut d' Investigacions Biomèdiques August Pi i Sunyer” (IDIBAPS)
  • “Red Temática de Investigación en SIDA (Red de grupos del FIS)

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References

  • 1
    Bica I, McGovern B, Dhar R, Stone D, McGowan K, Scheib R, et al. Increasing mortality due to end-stage liver disease in patients with human immunodeficiency virus infection. Clin Infect Dis 2001; 32: 492–497.
  • 2
    Sulkowski M, Thomas D. Hepatitis C in the HIV-infected person. Ann Intern Med 2003; 138: 197–207.
  • 3
    Benhamou Y, Bochet M, Di Martino V, Charlotte F, Azria F, Coutellier A, et al. Liver fibrosis progression in human immunodeficiency virus and hepatitis C virus coinfected patients. The Multivirc Group. HEPATOLOGY 1999; 30: 1054–1058.
    Direct Link:
  • 4
    Graham CS, Baden LR, Yu E, Mrus JM, Carnie J, Heeren T, et al. Influence of human immunodeficiency virus infection on the course of hepatitis C virus infection: meta-analysis. Clin Infect Dis 2001; 33: 562–569.
  • 5
    Rullier A, Trimoulet P, Neau D, Bernard PH, Foucher J, Lacoste D, et al. Fibrosis is worse in HIV-HCV patients with low-level immunodepression referred for HCV treatment than in HCV-matched patients. Hum Pathol 2004; 35: 1088–1094.
  • 6
    Cooper CL, Cameron DW. Review of the effect of highly active antiretroviral therapy on hepatitis C virus (HCV) RNA levels in human immunodeficiency virus and HCV coinfection. Clin Infect Dis 2002; 35: 873–879.
  • 7
    Torriani FJ, Rodríguez-Torres M, Rockstroh JK, Lissen E, Gonzalez-García J, Lazzarin A, et al. APRICOT Study Group. Peginterferon Alfa-2a plus ribavirin for chronic hepatitis C virus infection in HIV-infected patients. N Engl J Med 2004; 351: 438–450.
  • 8
    Chung RT, Andersen J, Volberding P, Robbins GK, Liu T, Sherman KE, et al. AIDS Clinical Trials Group A5071 Study Team. Peginterferon Alfa-2a plus ribavirin versus interferon alfa-2a plus ribavirin for chronic hepatitis C in HIV-coinfected persons. N Engl J Med 2004; 351: 451–459.
  • 9
    Carrat F, Bani-Sadr F, Pol S, Rosenthal E, Lunel-Fabiani F, Benzekri A, et al. Pegylated interferon alfa-2b vs standard interferon alfa-2b, plus ribavirin, for chronic hepatitis C in HIV-infected patients: a randomized controlled trial. JAMA. 2004; 292: 2839–2848.
  • 10
    Laguno M, Murillas J, Blanco JL, Martínez E, Miquel R, Sánchez-Tapias JM, et al. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for treatment of HIV/HCV co-infected patients. AIDS 2004; 18: 27–36.
  • 11
    Data sheet of Pegasys. F. Hoffmann-La Roche Ltd., Basel, Switzerland.
  • 12
    Data sheet of Pegintron. Schering Corp., Kenilworth, NJ.
  • 13
    Cargnel A, Angeli E, Mainini A, Gubertini G, Giorgi R, Schiavini M, et al. Open, randomized, multicentre Italian trial on PEG-IFN plus ribavirin versus PEG-IFN monotherapy for chronic hepatitis C in HIV-coinfected patients on HAART. Antivir Ther 2005; 10: 309–317.
  • 14
    Soriano V, Miralles C, Berdún MA, Losada E, Aguirrebengoa K, Ocampo A, et al. Premature treatment discontinuation in HIV/HCV-coinfected patients receiving pegylated interferon plus weight-based ribavirin. Antivir Ther 2007; 12: 469–476.
  • 15
    Crespo M, Sauleda S, Esteban JI, Juarez A, Ribera E, Andreu AL, et al. Peginterferon alpha-2b plus ribavirin vs interferon alpha-2b plus ribavirin for chronic hepatitis C in HIV-coinfected patients. J Viral Hepat 2007; 14: 228–238.
    Direct Link:
  • 16
    Márquez-Peiró JF, Valero-Alcocer VE, Llopis-González A, Pérez-Peiró C. Effectiveness of peginterferon alpha-2a or -2b plus ribavirin in naïve patients with hepatitis C infection. Enferm Infecc Microbiol Clin 2008; 26: 135–140.
  • 17
    Almasio PL, Cavalletto L, Chemello L, Craxi A, Fahrbach K, Frame D, et al.; for the HCV Meta-Analysis Working Group. Efficacy of PEG-IFN alfa-2b vs PEG-IFN alfa-2a + ribavirin regimens in treatment-naive chronic HCV patients: a cumulative meta-analysis of retrospective data from 6 clinical sites. 56th annual meeting of the American Association for the Study of Liver Diseases (56th AASLD). November 2005: San Francisco, CA [Abstract 62599].
  • 18
    Poordad F, Tran TT, Ayoub W, Patel Y, Chan L. A comparison of sustained viral response in patients with chronic hepatitis C virus (HCV) treated with peginterferon alfa-2a (peg2a) versus peginterferon alfa-2b (peg2b) and ribavirin. 70th Annual Scientific Meeting of the ACG 2005. October 2005: Honolulu, HI [Abstract 325].
  • 19
    Silva M, Poo J, Wagner F, Jackson M, Cutler D, Grace M, et al. A randomised trial to compare the pharmacodynamic, and antiviral effects peginterferon alfa-2b and peginterferon alfa2a in patients with chronic hepatitis C (Compare). J Hepatol 2006; 45: 204–213.
  • 20
    Berenguer J, Gonzalez J, Lopez Aldeguer J, Von-Wichman MA, Quereda C, Pulido F, et al. Peginterferon alfa-2a plus ribavirin vs peginterferon alfa-2b plus ribavirin for chronic hepatitis C virus infection in HIV-infected patients. 47th Interscience Conference on Antimicrobial Agents and Chemotherapy (47th ICAAC). September 2007: Chicago [Abstract V-1897].
  • 21
    Sulkowski M, Lawitz E, Shiffman ML, Muir AJ, Galler G, McCone J, et al. Final results of the IDEAL (individualized dosing efficacy vs. flat dosing to assess optimal pegylated interferon therapy Phase IIIB study. 43th European Association for the Study of the Liver (43th EASL). April 2008: Milan, Italy [Abstract LB-991].
  • 22
    Ascione A, De Luca M, Tartaglione MT, Lampasi F, Galeota Lanza A, Picciotto FP, et al. Peginterferon alpha-2a plus ribavirin versus peginterferon alpha-2b plus ribavirin in naive patients with chronic hepatitis C virus infection: results of a prospective randomised trial. 43th European Association for the Study of the Liver (43th EASL). April 2008: Milan, Italy [Abstract LB-990].
  • 23
    Germer JJ, Rys PN, Thorvilson JN, Persing DH. Determination of hepatitis C virus genotype by direct sequence analysis of products generated with the Amplicor HCV test. J Clin Microbiol 1999; 37: 2625–2630.
  • 24
    Scheuer PJ. Classification of chronic viral hepatitis: a need for reassessment. J Hepatol 1991; 13: 372–374.
  • 25
    International Statistical Classification of Diseases and Related Health Problems, 1989 Revision. Geneva, Switzerland: World Health Organization; 1992.
  • 26
    Doménech JM. Bioestadística. Metodos estadísticos para investigadores. Barcelona, Spain: E Herder; 1980, 126 pp.
  • 27
    Dore GJ, Torriani FJ, Rodriguez-Torres M, Bräu N, Sulkowski M, Lamoglia RS, et al. Baseline factors prognostic of sustained virological response in patients with HIV-hepatitis C virus co-infection. AIDS 2007; 21: 1555–1559.
  • 28
    Schmid M, Kreil A, Jessner W, Homoncik M, Datz C, Gangl A, et al. Suppression of haematopoiesis during therapy of chronic hepatitis C with different interferon alpha mono and combination therapy regimens. Gut 2005; 54: 1014–1020.
  • 29
    Mira JA, López-Cortés LF, Merino D, Arizcorreta-Yarza A, Rivero A, Collado A, et al. Predictors of severe haematological toxicity secondary to pegylated interferon plus ribavirin treatment in HIV-HCV-coinfected patients. Antivir Ther 2007; 12: 1225–1235.
  • 30
    Fuster D, Huertas JA, Gómez G, Solà R, González García J, et al.. Baseline factors associated with haematological toxicity that leads to a dosage reduction of pegylated interferon-alpha2a and ribavirin in HIV- and HCV-coinfected patients on HCV antiviral therapy. Antivir Ther 2005; 10: 841–847.
  • 31
    Núñez M, Ocampo A, Aguirrebengoa K, Cervantes M, Pascual A, Echeverria S, et al; PRESCO Team. Incidence of anaemia and impact on sustained virological response in HIV/HCV-coinfected patients treated with pegylated interferon plus ribavirin. J Viral Hepat 2008; 15: 363–369.
    Direct Link:
  • 32
    Jacobson IM, Brown RS Jr, Freilich B, Afdhal N, Kwo PY, Santoro J, et al; WIN-R Study Group. Peginterferon alfa-2b and weight-based or flat-dose ribavirin in chronic hepatitis C patients: a randomized trial. HEPATOLOGY 2007; 46: 971–981.
    Direct Link:
  • 33
    Fried MW, Shiffman ML, Reddy KR, Smith C, Marinos G, Gonçales FL Jr, et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med 2002; 347: 975–982.
  • 34
    Manss MP, McHutchinson JG, Gordon SC, Rustgi VK, Shiffman M, Reindollar R, et al. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet 2001; 358: 958–965.
  • 35
    Torriani F, Ribeiro R, Gilbert T, Schrenk UM, Clauson M, Pacheco DM, et al. HCV and HIV dynamics during HCV treatment in HCV/HIV coinfection. J Infect Dis 2003; 188: 1498–1507.
  • 36
    Soriano V, Nunez M, Camino N, Maida I, Barreiro P, Romero M, et al. Hepatitis C virus-RNA clearance in HIV-coinfected patients with chronic hepatitis C treated with pegylated interferon plus ribavirin. Antivir Ther 2004; 9: 505–509.
  • 37
    Laguno M, Larrousse M, Murillas J, Blanco JL, León A, Milinkovic A, et al. Predictive value of early virologic response in HIV/hepatitis C virus-coinfected patients treated with an interferon-based regimen plus ribavirin. J Acquir Immune Defic Syndr 2007; 44: 174–178.
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