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Antiviral effects of peginterferon alpha-2b and ribavirin following 24-week monotherapy of telaprevir in Japanese hepatitis C patients

  • Original Article—Liver, Pancreas, and Biliary Tract
  • Published:
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Abstract

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 24 weeks, and outcomes of the off-study treatment with peginterferon alpha-2b and ribavirin among Japanese female patients at a median age of 54 years 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 (750 mg every 8 h) alone for 24 weeks. 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 24 weeks 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.

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Authors and Affiliations

  1. Department of Gastroenterology, Sapporo Kosei General Hospital, North-3 East-8, Chuou-Ku, Sapporo, Hokkaido, 060-0033, Japan

    Itaru Ozeki, Jun Akaike, Yoshiyasu Karino, Tomohiro Arakawa, Yasuaki Kuwata, Takumi Ohmura, Takahiro Sato & Joji Toyota

  2. Research and Development Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan

    Naohiro Kamiya & Ichimaro Yamada

  3. Programs for Biomedical Research, Division of Frontier Medical Science, Department of Medical and Molecular Science, Graduate School of Biomedical Science, Hiroshima University, Hiroshima, Japan

    Kazuaki Chayama

  4. Department of Hepatology, Toranomon Hospital, Kawasaki, Japan

    Hiromitsu Kumada

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  1. Itaru Ozeki
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  2. Jun Akaike
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Correspondence to Joji Toyota.

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Ozeki, I., Akaike, J., Karino, Y. et al. Antiviral effects of peginterferon alpha-2b and ribavirin following 24-week monotherapy of telaprevir in Japanese hepatitis C patients. J Gastroenterol 46, 929–937 (2011). https://doi.org/10.1007/s00535-011-0411-0

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  • DOI: https://doi.org/10.1007/s00535-011-0411-0

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