caa a22 4500 445888105 CHVBK 20180317145606.0 cr unu---uuuuu 170323e20110701xx s 000 0 eng 10.1007/s00535-011-0411-0 doi (NATIONALLICENCE)springer-10.1007/s00535-011-0411-0 Antiviral effects of peginterferon alpha-2b and ribavirin following 24-week monotherapy of telaprevir in Japanese hepatitis C patients [Elektronische Daten] [Itaru Ozeki, Jun Akaike, Yoshiyasu Karino, Tomohiro Arakawa, Yasuaki Kuwata, Takumi Ohmura, Takahiro Sato, Naohiro Kamiya, Ichimaro Yamada, Kazuaki Chayama, Hiromitsu Kumada, Joji Toyota] Background/aims: Anemia is commonly observed as a side effect in a treatment with protease inhibitors combined with peginterferon alpha and ribavirin for hepatitis C virus infection. This study assessed the safety, tolerability, viral kinetics, and selection of variants in telaprevir monotherapy for 24weeks, and outcomes of the off-study treatment with peginterferon alpha-2b and ribavirin among Japanese female patients at a median age of 54years who were difficult to treat with the standard therapy (peginterferon alpha-2b and ribavirin) alone in Japan. Methods: Four treatment-naïve patients with chronic hepatitis C virus subtype 1b infection received telaprevir (750mg every 8h) alone for 24weeks. All patients then started the off-study treatment with peginterferon alpha-2b and ribavirin. Safety, tolerability, hepatitis C virus RNA levels, and emergence of telaprevir-resistant variants were monitored. Results: During the 24weeks of telaprevir monotherapy, there was no discontinuation due to adverse events, but 2 patients stopped the intake at weeks 6 and 15 because of viral breakthrough. Emergence of telaprevir-resistant variants was observed in 3 patients who showed viral breakthrough. These variants were eliminated by the off-study treatment, and sustained virological response was achieved in all patients. Conclusions: Anemia was manageable by carefully adjusting the ribavirin dosage in the standard therapy that followed telaprevir monotherapy. This sequential regimen seems to be safer and more tolerable than the triple combination of telaprevir, peginterferon alpha, and ribavirin, especially among elderly females with low baseline hemoglobin. Springer, 2011 Hepatitis C therapy nationallicence Telaprevir nationallicence Ribavirin nationallicence Anemia nationallicence Ozeki Itaru Department of Gastroenterology, Sapporo Kosei General Hospital, North-3 East-8, Chuou-Ku, 060-0033, Sapporo, Hokkaido, Japan aut Akaike Jun Department of Gastroenterology, Sapporo Kosei General Hospital, North-3 East-8, Chuou-Ku, 060-0033, Sapporo, Hokkaido, Japan aut Karino Yoshiyasu Department of Gastroenterology, Sapporo Kosei General Hospital, North-3 East-8, Chuou-Ku, 060-0033, Sapporo, Hokkaido, Japan aut Arakawa Tomohiro Department of Gastroenterology, Sapporo Kosei General Hospital, North-3 East-8, Chuou-Ku, 060-0033, Sapporo, Hokkaido, Japan aut Kuwata Yasuaki Department of Gastroenterology, Sapporo Kosei General Hospital, North-3 East-8, Chuou-Ku, 060-0033, Sapporo, Hokkaido, Japan aut Ohmura Takumi Department of Gastroenterology, Sapporo Kosei General Hospital, North-3 East-8, Chuou-Ku, 060-0033, Sapporo, Hokkaido, Japan aut Sato Takahiro Department of Gastroenterology, Sapporo Kosei General Hospital, North-3 East-8, Chuou-Ku, 060-0033, Sapporo, Hokkaido, Japan aut Kamiya Naohiro Research and Development Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan aut Yamada Ichimaro Research and Development Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan aut Chayama Kazuaki Programs for Biomedical Research, Division of Frontier Medical Science, Department of Medical and Molecular Science, Graduate School of Biomedical Science, Hiroshima University, Hiroshima, Japan aut Kumada Hiromitsu Department of Hepatology, Toranomon Hospital, Kawasaki, Japan aut Toyota Joji Department of Gastroenterology, Sapporo Kosei General Hospital, North-3 East-8, Chuou-Ku, 060-0033, Sapporo, Hokkaido, Japan aut Journal of Gastroenterology Springer Japan 46/7(2011-07-01), 929-937 0944-1174 46:7<929 2011 46 535 https://doi.org/10.1007/s00535-011-0411-0 text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/s00535-011-0411-0 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Ozeki Itaru Department of Gastroenterology, Sapporo Kosei General Hospital, North-3 East-8, Chuou-Ku, 060-0033, Sapporo, Hokkaido, Japan aut NATIONALLICENCE 700 1- Akaike Jun Department of Gastroenterology, Sapporo Kosei General Hospital, North-3 East-8, Chuou-Ku, 060-0033, Sapporo, Hokkaido, Japan aut NATIONALLICENCE 700 1- Karino Yoshiyasu Department of Gastroenterology, Sapporo Kosei General Hospital, North-3 East-8, Chuou-Ku, 060-0033, Sapporo, Hokkaido, Japan aut NATIONALLICENCE 700 1- Arakawa Tomohiro Department of Gastroenterology, Sapporo Kosei General Hospital, North-3 East-8, Chuou-Ku, 060-0033, Sapporo, Hokkaido, Japan aut NATIONALLICENCE 700 1- Kuwata Yasuaki Department of Gastroenterology, Sapporo Kosei General Hospital, North-3 East-8, Chuou-Ku, 060-0033, Sapporo, Hokkaido, Japan aut NATIONALLICENCE 700 1- Ohmura Takumi Department of Gastroenterology, Sapporo Kosei General Hospital, North-3 East-8, Chuou-Ku, 060-0033, Sapporo, Hokkaido, Japan aut NATIONALLICENCE 700 1- Sato Takahiro Department of Gastroenterology, Sapporo Kosei General Hospital, North-3 East-8, Chuou-Ku, 060-0033, Sapporo, Hokkaido, Japan aut NATIONALLICENCE 700 1- Kamiya Naohiro Research and Development Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan aut NATIONALLICENCE 700 1- Yamada Ichimaro Research and Development Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan aut NATIONALLICENCE 700 1- Chayama Kazuaki Programs for Biomedical Research, Division of Frontier Medical Science, Department of Medical and Molecular Science, Graduate School of Biomedical Science, Hiroshima University, Hiroshima, Japan aut NATIONALLICENCE 700 1- Kumada Hiromitsu Department of Hepatology, Toranomon Hospital, Kawasaki, Japan aut NATIONALLICENCE 700 1- Toyota Joji Department of Gastroenterology, Sapporo Kosei General Hospital, North-3 East-8, Chuou-Ku, 060-0033, Sapporo, Hokkaido, Japan aut NATIONALLICENCE 773 0- Journal of Gastroenterology Springer Japan 46/7(2011-07-01), 929-937 0944-1174 46:7<929 2011 46 535 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer