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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 |
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| Authors: | 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 |
| Institution: | 1. Liver Institute of Virginia, Bon Secours Health System, Richmond and Newport News, 5855 Bremo Road, Suite 509, Richmond, VA, 23226, USA 2. Department of Gastroenterology, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil 3. Department of Internal Medicine, Medizinische Universit?tsklinik Tübingen, Tübingen, Germany 4. Hepatology Section, Department of Gastroenterology and Rheumatology, Universit?tsklinikum Leipzig, Leipzig, Germany 5. Hospital Geral, Santa Casa da Misericórdia do Rio de Janeiro, Rio de Janeiro, Brazil 6. Kirby Institute, The University of New South Wales and St. Vincent’s Hospital, Sydney, NSW, Australia 7. Department of Gastroenterology, Escola Paulista de Medicina, UNIFESP, S?o Paulo, Brazil 8. Infectious Diseases Research Unit, ABC Foundation Medical School, Santo André, Brazil 9. Medical Sciences, Pontifícia Universidade Católica de Campinas, S?o Paulo, Brazil 10. Centro de Investigación Farmacéutica Especializada, Guadalajara, JAL, Mexico 11. Centre for Infectious Diseases, Universidade Federal do Espírito Santo, Vitória, Brazil 12. Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University School of Medicine, Richmond, VA, USA 13. Division of Infectious Diseases, University of Alberta, Edmonton, AB, Canada 14. IST GmbH, Mannheim, Germany 15. F. Hoffmann-La Roche Ltd, Basel, Switzerland 17. AbbVie, Chicago, IL, USA 16. Department of Medicine 1, J.W. Goethe University Hospital, Frankfurt, Germany |
| Abstract: | Background and aimsThe 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).MethodsN-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.ResultsTwo 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 %).ConclusionsIt 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. |
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