Takeshi Okanoue1, Toshihide Shima1, Chitomi Hasebe2, Yoshiyasu Karino3, Fumio Imazeki4, Takashi Kumada5, Masahito Minami6, Yasuharu Imai7, Harumasa Yoshihara8, Eiji Mita9, Teruhisa Morikawa10, Shuhei Nishiguchi11, Yoshiiku Kawakami12, Hideyuki Nomura13, Shotaro Sakisaka14, Masayuki Kurosaki15, Hiroshi Yatsuhashi16, Makoto Oketani17, Hiroshi Kohno18, Akihide Masumoto19, Kenji Ikeda20, Hiromitsu Kumada20. 1. Center of Gastroenterology and Hepatology, Saiseikai Suita Hospital, Suita, Japan. 2. Department of Gastroenterology, Asahikawa Red Cross Hospital, Asahikawa, Japan. 3. Department of Hepatology, Sapporo Kohseiren Hospital, Sapporo, Japan. 4. Department of Gastroenterology and Nephrology, Chiba University, Chiba, Japan. 5. Department of Gastroenterology and Hepatology, Ogaki Municipal Hospital, Ogaki, Japan. 6. Department of Gastroenterology, Kyoto Prefectural University of Medicine, Kyoto, Japan. 7. Department of Gastroenterology, Ikeda Municipal Hospital, Ikeda, Japan. 8. Department of Gastroenterology, Osaka Rousai Hospital, Sakai, Japan. 9. Department of Gastroenterology, National Hospital Organization Osaka Medical Center, Osaka, Japan. 10. Department of Hepatology, Akashi Municipal Hospital, Akashi, Japan. 11. Division of Hepatobiliary and Pancreatic Medicine, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan. 12. Department of Gastroenterology and Metabolism, Hiroshima University, Hiroshima, Japan. 13. Hepatology Center, Shin-Kokura Hospital, Kitakyushu, Japan. 14. Department of Gastroenterolgy, Fukuoka University, Fukuoka, Japan. 15. Department of Gastroenterology, Musashino Red Cross Hospital, Musashino, Japan. 16. Clinical Research Center, National Hospital Organization Nagasaki Medical Center, Nagasaki, Japan. 17. Department of Gastroenterology and Life Style-Related Disease, Kagoshima University, Kagoshima, Japan. 18. Department of Gastroenterology, National Hospital Organization, Kure Medical Center and Chugoku Cancer Center, Kure, Japan. 19. Department of Hepatology, Aso Iizuka Hospital, Iizuka, Japan. 20. Department of Hepatology, Toranomon Hospital, Tokyo, Japan.
Abstract
AIM: We analyzed the 5-year post-treatment response to peginterferon α-2a (PEG IFN-α-2a) in hepatitis B e-antigen (HBeAg) positive and negative chronic hepatitis B patients. METHODS: One hundred and thirty-seven chronic hepatitis B (CHB) patients receiving 90 μg or 180 μg of PEG IFN-α-2a for 24 or 48 weeks in phase II or III studies were enrolled in the study, including 100 HBeAg positive patients and 37 HBeAg negative patients; 121 patients (88.4%) had genotype C. RESULTS: Of the 137 patients, 94 received additional antiviral therapy because of viral reactivation and 43 did not receive any additional antiviral treatment during follow up. Five years upon PEG IFN-α-2a treatment, 32 patients (23.4%) who did not receive any additional antiviral agent after PEG IFN-α-2a therapy achieved a good response (normal serum alanine aminotransferase, low-level hepatitis B virus [HBV] DNA, and HBeAg negativity). Female sex and low HBV DNA levels by the end of treatment were independently associated with favorable 5-year post-treatment responses. Forty-eight-week administration of PEG IFN-α-2a showed a better response (26.4%) than 24-week administration (18.0%). Six patients (4.3%), four males and two females, cleared hepatitis B surface antigen (HBsAg) during the 5-year follow-up period. CONCLUSION: The 48-week administration of PEG IFN-α-2a achieved better biochemical and virological responses than the 24-week administration, particularly in younger females. The 5-year post-treatment response rate was 23.4%; however, more than two-thirds of the patients received additional antiviral therapy because of viral reactivation after PEG IFN-α-2a treatment. HBsAg clearance was noted in six patients (4.3%). PEG IFN-α-2a is effective in young female patients.
AIM: We analyzed the 5-year post-treatment response to peginterferon α-2a (PEG IFN-α-2a) in hepatitis B e-antigen (HBeAg) positive and negative chronic hepatitis Bpatients. METHODS: One hundred and thirty-seven chronic hepatitis B (CHB) patients receiving 90 μg or 180 μg of PEG IFN-α-2a for 24 or 48 weeks in phase II or III studies were enrolled in the study, including 100 HBeAg positive patients and 37 HBeAg negative patients; 121 patients (88.4%) had genotype C. RESULTS: Of the 137 patients, 94 received additional antiviral therapy because of viral reactivation and 43 did not receive any additional antiviral treatment during follow up. Five years upon PEG IFN-α-2a treatment, 32 patients (23.4%) who did not receive any additional antiviral agent after PEG IFN-α-2a therapy achieved a good response (normal serum alanine aminotransferase, low-level hepatitis B virus [HBV] DNA, and HBeAg negativity). Female sex and low HBV DNA levels by the end of treatment were independently associated with favorable 5-year post-treatment responses. Forty-eight-week administration of PEG IFN-α-2a showed a better response (26.4%) than 24-week administration (18.0%). Six patients (4.3%), four males and two females, cleared hepatitis B surface antigen (HBsAg) during the 5-year follow-up period. CONCLUSION: The 48-week administration of PEG IFN-α-2a achieved better biochemical and virological responses than the 24-week administration, particularly in younger females. The 5-year post-treatment response rate was 23.4%; however, more than two-thirds of the patients received additional antiviral therapy because of viral reactivation after PEG IFN-α-2a treatment. HBsAg clearance was noted in six patients (4.3%). PEG IFN-α-2a is effective in young female patients.