1Liver Institute of Virginia, Bon Secours Health System, Richmond and Newport News, 5855 Bremo Road, Suite 509, Richmond, VA, 23226, USA. firstname.lastname@example.org.
2Department of Gastroenterology, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil. email@example.com.
3Department of Internal Medicine, Medizinische Universitätsklinik Tübingen, Tübingen, Germany. firstname.lastname@example.org.
4Hepatology Section, Department of Gastroenterology and Rheumatology, Universitätsklinikum Leipzig, Leipzig, Germany. email@example.com.
5Hospital Geral, Santa Casa da Misericórdia do Rio de Janeiro, Rio de Janeiro, Brazil. firstname.lastname@example.org.
6Kirby Institute, The University of New South Wales and St. Vincent's Hospital, Sydney, NSW, Australia. email@example.com.
7Department of Gastroenterology, Escola Paulista de Medicina, UNIFESP, São Paulo, Brazil. firstname.lastname@example.org.
8Infectious Diseases Research Unit, ABC Foundation Medical School, Santo André, Brazil. email@example.com.
9Medical Sciences, Pontifícia Universidade Católica de Campinas, São Paulo, Brazil. firstname.lastname@example.org.
10Department of Gastroenterology, Escola Paulista de Medicina, UNIFESP, São Paulo, Brazil. email@example.com.
11Centro de Investigación Farmacéutica Especializada, Guadalajara, JAL, Mexico. firstname.lastname@example.org.
12Centre for Infectious Diseases, Universidade Federal do Espírito Santo, Vitória, Brazil. email@example.com.
13Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University School of Medicine, Richmond, VA, USA. firstname.lastname@example.org.
14Division of Infectious Diseases, University of Alberta, Edmonton, AB, Canada. email@example.com.
15IST GmbH, Mannheim, Germany. marc.hohmann@ISTGmbH.com.
16F. Hoffmann-La Roche Ltd, Basel, Switzerland. firstname.lastname@example.org.
17AbbVie, Chicago, IL, USA. email@example.com.
18F. Hoffmann-La Roche Ltd, Basel, Switzerland. firstname.lastname@example.org.
19Department of Medicine 1, J.W. Goethe University Hospital, Frankfurt, Germany. email@example.com.
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).
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.
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 %).
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.