A Multicenter Study to Clarify the Optimal HCV-RNA Negative Period during Combined Therapy with Pegylated Interferon Plus Ribavirin in Patients with Chronic Hepatitis Caused by HCV Genotype 2

Sumiko Nagoshi; Yohei Koshima; Ikuo Nakamura; Junji Funyu; Chuichi Sekine; Youji Harada; Ko Nishikawa; Takeshi Yoshida; Atsushi Matsui; Naoki Sotome; Kenichi Toshima; So Takegoshi; Masao Shiomi; Masahiko Tanaka; Akira Saito; Kenji Fujiwara; Satoshi Mochida

doi:10.2169/internalmedicine.51.6237

ORIGINAL ARTICLES

A Multicenter Study to Clarify the Optimal HCV-RNA Negative Period during Combined Therapy with Pegylated Interferon Plus Ribavirin in Patients with Chronic Hepatitis Caused by HCV Genotype 2

Sumiko Nagoshi, Yohei Koshima, Ikuo Nakamura, Junji Funyu, Chuichi Sekine, Youji Harada, Ko Nishikawa, Takeshi Yoshida, Atsushi Matsui, Naoki Sotome, Kenichi Toshima, So Takegoshi, Masao Shiomi, Masahiko Tanaka, Akira Saito, Kenji Fujiwara, Satoshi Mochida

Author information

Sumiko Nagoshi
Department of Gastroenterology & Hepatology, Saitama Medical University, Japan
Yohei Koshima
Saitama Red Cross Hospital, Japan
Ikuo Nakamura
Saitama Medical Center, Jichi Medical University, Japan
Junji Funyu
Chichibu Hospital, Japan
Chuichi Sekine
Saiseikai Kawaguchi General Hospital, Japan
Youji Harada
Toda Chuo General Hospital, Japan
Ko Nishikawa
Ageo Central General Hospital, Japan
Takeshi Yoshida
Saitama Social Insurance Hospital, Japan
Atsushi Matsui
Shisei Hospital, Japan
Naoki Sotome
Kumagaya General Hospital, Japan
Kenichi Toshima
Musashiranzan Hospital, Japan
So Takegoshi
Asakadai Central General Hospital, Japan
Masao Shiomi
Shiomi Hospital, Japan
Masahiko Tanaka
Kanetsu Hospital, Japan
Akira Saito
Nishisaitama-chuo National Hospital, Japan
Kenji Fujiwara
Japan Labour Health and Welfare Organization, Yokohama Rosai Hospital, Japan
Satoshi Mochida
Department of Gastroenterology & Hepatology, Saitama Medical University, Japan

Keywords: chronic hepatitis, HCV, genotype 2, pegylated interferon, ribavirin, sustained virological response, rapid virological response

JOURNAL OPEN ACCESS

2012 Volume 51 Issue 1 Pages 9-15

DOI https://doi.org/10.2169/internalmedicine.51.6237

Details

Abstract

Objective A multicenter open trial was performed to clarify the optimal duration of combined pegylated interferon (Peg-IFN) plus ribavirin therapy in patients with chronic hepatitis caused by HCV genotype 2.
Methods A total of 100 patients seen between 2005 and 2007 received the combination therapy for 4 to 52 weeks. The cutoff value of the HCV-RNA-negative (titers under 1.7 Log IU/mL) period during the therapy to predict sustained virological response (SVR) was determined by ROC curve and multivariate logistic regression analyses. The result was validated in 48 patients between 2008 and 2009.
Results SVR was achieved in 78 patients. Serum HCV-RNA titers decreased to less than 1.7 Log IU/mL at 4 weeks of the therapy in 60 patients. The SVR rate in these patients was 85%, which was significantly higher than that of remaining 40 patients with a SVR rate of 68%. An HCV-RNA-negative period of ≥17 weeks was selected as the cutoff value, which showed a significant odds ratio of 4.77 for SVR. Among the 35 patients who showed a decrease of the serum HCV-RNA of less than 1.7 Log IU/mL between 8 and 16 weeks of therapy, the SVR rate was significantly higher in 16 patients with a serum HCV-RNA-negative period of ≥17 weeks (94%) than in 19 patients in whom the period was less than 17 weeks (63%). Similar results were obtained in the subsequent validation study.
Conclusion Prolonged combined Peg-IFN plus ribavirin therapy, with an HCV-RNA-negative period of ≥17 weeks, yielded good therapeutic outcomes in patients with chronic HCV genotype 2 hepatitis.

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