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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Abstract

Although two pegylated interferons (Peg-IFN) are available to treat chronic hepatitis C virus (HCV) infection, no head-to-head comparative studies have been published. We aim to compare the efficacy and safety of PEG IFN alfa-2b (PEG 2b) versus PEG IFN alfa-2a (PEG 2a), plus ribavirin (RBV). A prospective, randomized, multi-center, open-label clinical trial including 182 human immunodeficiency virus (HIV)–hepatitis C virus (HCV) patients naïve for HCV therapy was performed. Patients were assigned to PEG 2b (80-150 μg/week; n = 96) or PEG 2a (180 μg/week; n = 86), plus RBV (800-1200 mg/day) for 48 weeks. The primary endpoint was sustained virological response (SVR: negative HCV-RNA 24 weeks after completion of treatment). At baseline, both groups were well balanced: 73% male; 63% HCV genotype 1 through 4; 29% had fibrosis index of 3 or greater. The overall SVR was 44% (42% PEG 2b versus 46% PEG 2a, P = 0.65). Among genotypes 1 through 4, SVRs were 28% versus 32% (P = 0.67) and 62% versus 71% (P = 0.6) in genotypes 2 through 3 for PEG 2b and PEG 2a, respectively. Early virological response (EVR; ≥2 log reduction from baseline or negative HCV-RNA at week 12) was 70% in the PEG 2b group and 80% in the PEG 2a group (P = 0.13), reaching a positive predictive value of SVR of 64% and a negative predictive value of 100% in both arms. Side effects were present in 96% of patients but led to treatment discontinuation in 10% of patients (8% on PEG 2b and 13% on PEG 2a, P = 0.47). Conclusion: In patients with HIV, HCV therapy with PEG 2b or PEG 2a plus RBV had no significant differences in efficacy and safety. (HEPATOLOGY 2009;49:22-31.)

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