Hepatology International

, Volume 8, Issue 4, pp 517–526

Extended treatment with pegylated interferon alfa/ribavirin in patients with genotype 2/3 chronic hepatitis C who do not achieve a rapid virological response: final analysis of the randomised N-CORE trial

  • Mitchell L. Shiffman
  • Hugo Cheinquer
  • Christoph P. Berg
  • Thomas Berg
  • Cláudio de Figueiredo-Mendes
  • Gregory J. Dore
  • Maria Lúcia Ferraz
  • Maria Cássia Mendes-Corrêa
  • Maria Patelli Lima
  • Edison R. Parise
  • Alma Minerva Perez Rios
  • Tania Reuter
  • Arun J. Sanyal
  • Stephen D. Shafran
  • Marc Hohmann
  • Fernando Tatsch
  • George Bakalos
  • Stefan Zeuzem
Original Article

DOI: 10.1007/s12072-014-9555-3

Cite this article as:
Shiffman, M.L., Cheinquer, H., Berg, C.P. et al. Hepatol Int (2014) 8: 517. doi:10.1007/s12072-014-9555-3

Abstract

Background and aims

The combination of pegylated interferon alfa/ribavirin will likely remain the treatment of choice for HCV genotype 2/3 patients in financially constrained countries for the foreseeable future. Patients with poor on-treatment response may benefit from treatment extension. This study examined the effect of 48 versus 24 weeks of peginterferon alfa-2a/ribavirin on the sustained virological response (SVR) in patients with HCV genotype 2/3 who did not achieve rapid virological response (RVR).

Methods

N-CORE was a multicentre, randomised, phase III study. HCV genotype 2/3 patients receiving peginterferon alfa-2a/ribavirin without a rapid but with an early virological response were randomised at week 24 to stop treatment (Arm A) or continue to 48 weeks (Arm B). The primary efficacy endpoint was SVR.

Results

Two hundred thirty-five patients were enrolled. End of treatment response was similar in both treatment arms. SVR24 rates were not significantly greater in the extended treatment arm compared with the standard 24-week treatment in either the intention-to-treat or the per-protocol populations (61 vs. 52 %, p = 0.1934 and 63 vs. 52 %, p = 0.1461, respectively). Serious adverse events occurred more frequently in patients receiving extended treatment duration (12 %) versus 24-week therapy (4 %).

Conclusions

It is unclear whether the extension of peginterferon alfa-2a/ribavirin treatment may benefit HCV genotype 2/3 patients who do not achieve RVR. The study was stopped early because recruitment was slower than anticipated, and this may have limited the statistical impact of these findings.

Keywords

Hepatitis C virus Chronic hepatitis C Genotype 2/3 Peginterferon/ribavirin N-CORE Slow virological responders 

Copyright information

© Asian Pacific Association for the Study of the Liver 2014

Authors and Affiliations

  • Mitchell L. Shiffman
    • 1
  • Hugo Cheinquer
    • 2
  • Christoph P. Berg
    • 3
  • Thomas Berg
    • 4
  • Cláudio de Figueiredo-Mendes
    • 5
  • Gregory J. Dore
    • 6
  • Maria Lúcia Ferraz
    • 7
  • Maria Cássia Mendes-Corrêa
    • 8
  • Maria Patelli Lima
    • 9
  • Edison R. Parise
    • 7
  • Alma Minerva Perez Rios
    • 10
  • Tania Reuter
    • 11
  • Arun J. Sanyal
    • 12
  • Stephen D. Shafran
    • 13
  • Marc Hohmann
    • 14
  • Fernando Tatsch
    • 15
    • 17
  • George Bakalos
    • 15
  • Stefan Zeuzem
    • 16
  1. 1.Liver Institute of Virginia, Bon Secours Health System, Richmond and Newport NewsRichmondUSA
  2. 2.Department of GastroenterologyHospital de Clínicas de Porto AlegrePorto AlegreBrazil
  3. 3.Department of Internal MedicineMedizinische Universitätsklinik TübingenTübingenGermany
  4. 4.Hepatology Section, Department of Gastroenterology and RheumatologyUniversitätsklinikum LeipzigLeipzigGermany
  5. 5.Hospital GeralSanta Casa da Misericórdia do Rio de JaneiroRio de JaneiroBrazil
  6. 6.Kirby InstituteThe University of New South Wales and St. Vincent’s HospitalSydneyAustralia
  7. 7.Department of Gastroenterology, Escola Paulista de MedicinaUNIFESPSão PauloBrazil
  8. 8.Infectious Diseases Research UnitABC Foundation Medical SchoolSanto AndréBrazil
  9. 9.Medical SciencesPontifícia Universidade Católica de CampinasSão PauloBrazil
  10. 10.Centro de Investigación Farmacéutica EspecializadaGuadalajaraMexico
  11. 11.Centre for Infectious DiseasesUniversidade Federal do Espírito SantoVitóriaBrazil
  12. 12.Division of Gastroenterology, Hepatology and NutritionVirginia Commonwealth University School of MedicineRichmondUSA
  13. 13.Division of Infectious DiseasesUniversity of AlbertaEdmontonCanada
  14. 14.IST GmbHMannheimGermany
  15. 15.F. Hoffmann-La Roche LtdBaselSwitzerland
  16. 16.Department of Medicine 1J.W. Goethe University HospitalFrankfurtGermany
  17. 17.AbbVieChicagoUSA

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