Comparative safety study on severe anemia by simeprevir versus telaprevir-based triple therapy for chronic hepatitis C

The Kyushu University Liver Disease Study (KULDS) Group

研究成果: ジャーナルへの寄稿記事

11 引用 (Scopus)

抄録

Background and Aim: The addition of hepatitis C virus (HCV) NS3/4A protease inhibitors to the pegylated interferon (PEG-IFN) α and ribavirin combination regimen (triple therapy) has dramatically improved treatment outcome. Unfortunately, anemia remains a common adverse effect. This study was done to compare the development of severe anemia during simeprevir- or telaprevir-based triple therapy. Methods: This retrospective multicenter study consisted of 837 consecutive Japanese HCV genotype 1 patients treated in a real-world clinical setting, 811 of whom were enrolled (simeprevir 281, telaprevir 530). The inosine triphosphate pyrophosphatase (ITPA) genotype at rs1127354 was determined for all studied patients. Logistic regression was done after propensity score matching to assess the risk of development of severe anemia. Results: Propensity score matching of the entire study population yielded 266 matched pairs. Severe anemia (nadir hemoglobin <9.0g/dL) was developed during the treatment period by 81 (30.5%) and 144 (54.1%) patients treated with simeprevir and telaprevir, respectively. Treatment with simeprevir was independently associated with a lower risk of severe anemia (odds ratio 0.25, 95% confidence interval 0.16-0.38, P<0.0001). Moreover, ITPA genotype, age, hemoglobin level, and estimated glomerular filtration rate at baseline were also independent factors associated with the development of severe anemia. Conclusions: Patients treated with simeprevir-based triple therapy have a lower risk of the development of severe anemia than those treated with telaprevir. Moreover, ITPA genotype and age may be useful for individualizing treatment to reduce the risk of anemia-related adverse effects.

元の言語英語
ページ(範囲)1309-1316
ページ数8
ジャーナルJournal of Gastroenterology and Hepatology (Australia)
30
発行部数8
DOI
出版物ステータス出版済み - 8 1 2015

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Chronic Hepatitis C
Anemia
Safety
Pyrophosphatases
Inosine Triphosphate
Genotype
Propensity Score
Therapeutics
Hemoglobins
telaprevir
Simeprevir
Ribavirin
Protease Inhibitors
Glomerular Filtration Rate
Hepacivirus
Interferons
Multicenter Studies
Retrospective Studies
Logistic Models
Odds Ratio

All Science Journal Classification (ASJC) codes

  • Hepatology
  • Gastroenterology

これを引用

Comparative safety study on severe anemia by simeprevir versus telaprevir-based triple therapy for chronic hepatitis C. / The Kyushu University Liver Disease Study (KULDS) Group.

:: Journal of Gastroenterology and Hepatology (Australia), 巻 30, 番号 8, 01.08.2015, p. 1309-1316.

研究成果: ジャーナルへの寄稿記事

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title = "Comparative safety study on severe anemia by simeprevir versus telaprevir-based triple therapy for chronic hepatitis C",
abstract = "Background and Aim: The addition of hepatitis C virus (HCV) NS3/4A protease inhibitors to the pegylated interferon (PEG-IFN) α and ribavirin combination regimen (triple therapy) has dramatically improved treatment outcome. Unfortunately, anemia remains a common adverse effect. This study was done to compare the development of severe anemia during simeprevir- or telaprevir-based triple therapy. Methods: This retrospective multicenter study consisted of 837 consecutive Japanese HCV genotype 1 patients treated in a real-world clinical setting, 811 of whom were enrolled (simeprevir 281, telaprevir 530). The inosine triphosphate pyrophosphatase (ITPA) genotype at rs1127354 was determined for all studied patients. Logistic regression was done after propensity score matching to assess the risk of development of severe anemia. Results: Propensity score matching of the entire study population yielded 266 matched pairs. Severe anemia (nadir hemoglobin <9.0g/dL) was developed during the treatment period by 81 (30.5{\%}) and 144 (54.1{\%}) patients treated with simeprevir and telaprevir, respectively. Treatment with simeprevir was independently associated with a lower risk of severe anemia (odds ratio 0.25, 95{\%} confidence interval 0.16-0.38, P<0.0001). Moreover, ITPA genotype, age, hemoglobin level, and estimated glomerular filtration rate at baseline were also independent factors associated with the development of severe anemia. Conclusions: Patients treated with simeprevir-based triple therapy have a lower risk of the development of severe anemia than those treated with telaprevir. Moreover, ITPA genotype and age may be useful for individualizing treatment to reduce the risk of anemia-related adverse effects.",
author = "{The Kyushu University Liver Disease Study (KULDS) Group} and Eiichi Ogawa and Norihiro Furusyo and Eiji Kajiwara and Hideyuki Nomura and Akira Kawano and Kazuhiro Takahashi and Kazufumi Dohmen and Takeaki Satoh and Koichi Azuma and Makoto Nakamuta and Toshimasa Koyanagi and Kazuhiro Kotoh and Shinji Shimoda and Jun Hayashi",
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T1 - Comparative safety study on severe anemia by simeprevir versus telaprevir-based triple therapy for chronic hepatitis C

AU - The Kyushu University Liver Disease Study (KULDS) Group

AU - Ogawa, Eiichi

AU - Furusyo, Norihiro

AU - Kajiwara, Eiji

AU - Nomura, Hideyuki

AU - Kawano, Akira

AU - Takahashi, Kazuhiro

AU - Dohmen, Kazufumi

AU - Satoh, Takeaki

AU - Azuma, Koichi

AU - Nakamuta, Makoto

AU - Koyanagi, Toshimasa

AU - Kotoh, Kazuhiro

AU - Shimoda, Shinji

AU - Hayashi, Jun

PY - 2015/8/1

Y1 - 2015/8/1

N2 - Background and Aim: The addition of hepatitis C virus (HCV) NS3/4A protease inhibitors to the pegylated interferon (PEG-IFN) α and ribavirin combination regimen (triple therapy) has dramatically improved treatment outcome. Unfortunately, anemia remains a common adverse effect. This study was done to compare the development of severe anemia during simeprevir- or telaprevir-based triple therapy. Methods: This retrospective multicenter study consisted of 837 consecutive Japanese HCV genotype 1 patients treated in a real-world clinical setting, 811 of whom were enrolled (simeprevir 281, telaprevir 530). The inosine triphosphate pyrophosphatase (ITPA) genotype at rs1127354 was determined for all studied patients. Logistic regression was done after propensity score matching to assess the risk of development of severe anemia. Results: Propensity score matching of the entire study population yielded 266 matched pairs. Severe anemia (nadir hemoglobin <9.0g/dL) was developed during the treatment period by 81 (30.5%) and 144 (54.1%) patients treated with simeprevir and telaprevir, respectively. Treatment with simeprevir was independently associated with a lower risk of severe anemia (odds ratio 0.25, 95% confidence interval 0.16-0.38, P<0.0001). Moreover, ITPA genotype, age, hemoglobin level, and estimated glomerular filtration rate at baseline were also independent factors associated with the development of severe anemia. Conclusions: Patients treated with simeprevir-based triple therapy have a lower risk of the development of severe anemia than those treated with telaprevir. Moreover, ITPA genotype and age may be useful for individualizing treatment to reduce the risk of anemia-related adverse effects.

AB - Background and Aim: The addition of hepatitis C virus (HCV) NS3/4A protease inhibitors to the pegylated interferon (PEG-IFN) α and ribavirin combination regimen (triple therapy) has dramatically improved treatment outcome. Unfortunately, anemia remains a common adverse effect. This study was done to compare the development of severe anemia during simeprevir- or telaprevir-based triple therapy. Methods: This retrospective multicenter study consisted of 837 consecutive Japanese HCV genotype 1 patients treated in a real-world clinical setting, 811 of whom were enrolled (simeprevir 281, telaprevir 530). The inosine triphosphate pyrophosphatase (ITPA) genotype at rs1127354 was determined for all studied patients. Logistic regression was done after propensity score matching to assess the risk of development of severe anemia. Results: Propensity score matching of the entire study population yielded 266 matched pairs. Severe anemia (nadir hemoglobin <9.0g/dL) was developed during the treatment period by 81 (30.5%) and 144 (54.1%) patients treated with simeprevir and telaprevir, respectively. Treatment with simeprevir was independently associated with a lower risk of severe anemia (odds ratio 0.25, 95% confidence interval 0.16-0.38, P<0.0001). Moreover, ITPA genotype, age, hemoglobin level, and estimated glomerular filtration rate at baseline were also independent factors associated with the development of severe anemia. Conclusions: Patients treated with simeprevir-based triple therapy have a lower risk of the development of severe anemia than those treated with telaprevir. Moreover, ITPA genotype and age may be useful for individualizing treatment to reduce the risk of anemia-related adverse effects.

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