Importance of virological response in the early stage of telaprevir-based triple therapy for hepatitis C

Satoshi Hiramine, Norihiro Furusyo, Eiichi Ogawa, Makoto Nakamuta, Eiji Kajiwara, Hideyuki Nomura, Kazufumi Dohmen, Kazuhiro Takahashi, Takeaki Satoh, Koichi Azuma, Akira Kawano, Toshimasa Koyanagi, Kazuhiro Kotoh, Shinji Shimoda, Jun Hayashi

Research output: Contribution to journalArticle

Abstract

AIM: To investigate the efficacy of virological response (VR) to telaprevir (TVR)-based triple therapy in predicting treatment outcome of hepatitis C. METHODS: This prospective, multicenter study consisted of 253 Japanese patients infected with hepatitis C virus (HCV) genotype 1b. All received 12 wk of TVR in combination with 24 wk of pegylated-interferon-α (IFN-α) and ribavirin. Serum HCV RNA was tested at weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24. VR was defined as undetectable serum HCV RNA. Sustained virological response (SVR) was VR at 24 wk after the end of treatment and was regarded as a successful outcome. RESULTS: Of 253 patients, 207 (81.8%) achieved SVR. The positive predictive value of VR for SVR was 100% at week 2, after which it gradually decreased, and was over 85% to week 12. The negative predictive value (NPV) gradually increased, reaching 100% at week 12. The upslope of the NPV showed a large increase from week 4 (40.6%) to week 6 (82.4%). There was a moderate concordance between the SVR and VR at week 6 (kappa coefficient = 0.44), although other VRs had poor concordance to SVR. Multiple logistic regression analysis extracted VR at week 6 (P < 0.0001, OR = 63.8) as an independent factor contributing to SVR. In addition, the interleukin-28B single nucleotide polymorphism and response to previous pegylated-IFN-α and ribavirin therapy were identified as independent factors for SVR. CONCLUSION: VR at week 6, but not at week 4, is an efficient predictor of both SVR and non-SVR to TVR-based triple therapy.

Original languageEnglish
Pages (from-to)2688-2695
Number of pages8
JournalWorld Journal of Hepatology
Volume7
Issue number26
DOIs
Publication statusPublished - Jan 1 2015

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Hepatitis C
Hepacivirus
Ribavirin
Interferons
RNA
Interleukins
Therapeutics
Serum
Multicenter Studies
Single Nucleotide Polymorphism
Logistic Models
Genotype
Regression Analysis
Prospective Studies
telaprevir

All Science Journal Classification (ASJC) codes

  • Hepatology

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Importance of virological response in the early stage of telaprevir-based triple therapy for hepatitis C. / Hiramine, Satoshi; Furusyo, Norihiro; Ogawa, Eiichi; Nakamuta, Makoto; Kajiwara, Eiji; Nomura, Hideyuki; Dohmen, Kazufumi; Takahashi, Kazuhiro; Satoh, Takeaki; Azuma, Koichi; Kawano, Akira; Koyanagi, Toshimasa; Kotoh, Kazuhiro; Shimoda, Shinji; Hayashi, Jun.

In: World Journal of Hepatology, Vol. 7, No. 26, 01.01.2015, p. 2688-2695.

Research output: Contribution to journalArticle

Hiramine, S, Furusyo, N, Ogawa, E, Nakamuta, M, Kajiwara, E, Nomura, H, Dohmen, K, Takahashi, K, Satoh, T, Azuma, K, Kawano, A, Koyanagi, T, Kotoh, K, Shimoda, S & Hayashi, J 2015, 'Importance of virological response in the early stage of telaprevir-based triple therapy for hepatitis C', World Journal of Hepatology, vol. 7, no. 26, pp. 2688-2695. https://doi.org/10.4254/wjh.v7.i26.2688
Hiramine, Satoshi ; Furusyo, Norihiro ; Ogawa, Eiichi ; Nakamuta, Makoto ; Kajiwara, Eiji ; Nomura, Hideyuki ; Dohmen, Kazufumi ; Takahashi, Kazuhiro ; Satoh, Takeaki ; Azuma, Koichi ; Kawano, Akira ; Koyanagi, Toshimasa ; Kotoh, Kazuhiro ; Shimoda, Shinji ; Hayashi, Jun. / Importance of virological response in the early stage of telaprevir-based triple therapy for hepatitis C. In: World Journal of Hepatology. 2015 ; Vol. 7, No. 26. pp. 2688-2695.
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AU - Hiramine, Satoshi

AU - Furusyo, Norihiro

AU - Ogawa, Eiichi

AU - Nakamuta, Makoto

AU - Kajiwara, Eiji

AU - Nomura, Hideyuki

AU - Dohmen, Kazufumi

AU - Takahashi, Kazuhiro

AU - Satoh, Takeaki

AU - Azuma, Koichi

AU - Kawano, Akira

AU - Koyanagi, Toshimasa

AU - Kotoh, Kazuhiro

AU - Shimoda, Shinji

AU - Hayashi, Jun

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N2 - AIM: To investigate the efficacy of virological response (VR) to telaprevir (TVR)-based triple therapy in predicting treatment outcome of hepatitis C. METHODS: This prospective, multicenter study consisted of 253 Japanese patients infected with hepatitis C virus (HCV) genotype 1b. All received 12 wk of TVR in combination with 24 wk of pegylated-interferon-α (IFN-α) and ribavirin. Serum HCV RNA was tested at weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24. VR was defined as undetectable serum HCV RNA. Sustained virological response (SVR) was VR at 24 wk after the end of treatment and was regarded as a successful outcome. RESULTS: Of 253 patients, 207 (81.8%) achieved SVR. The positive predictive value of VR for SVR was 100% at week 2, after which it gradually decreased, and was over 85% to week 12. The negative predictive value (NPV) gradually increased, reaching 100% at week 12. The upslope of the NPV showed a large increase from week 4 (40.6%) to week 6 (82.4%). There was a moderate concordance between the SVR and VR at week 6 (kappa coefficient = 0.44), although other VRs had poor concordance to SVR. Multiple logistic regression analysis extracted VR at week 6 (P < 0.0001, OR = 63.8) as an independent factor contributing to SVR. In addition, the interleukin-28B single nucleotide polymorphism and response to previous pegylated-IFN-α and ribavirin therapy were identified as independent factors for SVR. CONCLUSION: VR at week 6, but not at week 4, is an efficient predictor of both SVR and non-SVR to TVR-based triple therapy.

AB - AIM: To investigate the efficacy of virological response (VR) to telaprevir (TVR)-based triple therapy in predicting treatment outcome of hepatitis C. METHODS: This prospective, multicenter study consisted of 253 Japanese patients infected with hepatitis C virus (HCV) genotype 1b. All received 12 wk of TVR in combination with 24 wk of pegylated-interferon-α (IFN-α) and ribavirin. Serum HCV RNA was tested at weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24. VR was defined as undetectable serum HCV RNA. Sustained virological response (SVR) was VR at 24 wk after the end of treatment and was regarded as a successful outcome. RESULTS: Of 253 patients, 207 (81.8%) achieved SVR. The positive predictive value of VR for SVR was 100% at week 2, after which it gradually decreased, and was over 85% to week 12. The negative predictive value (NPV) gradually increased, reaching 100% at week 12. The upslope of the NPV showed a large increase from week 4 (40.6%) to week 6 (82.4%). There was a moderate concordance between the SVR and VR at week 6 (kappa coefficient = 0.44), although other VRs had poor concordance to SVR. Multiple logistic regression analysis extracted VR at week 6 (P < 0.0001, OR = 63.8) as an independent factor contributing to SVR. In addition, the interleukin-28B single nucleotide polymorphism and response to previous pegylated-IFN-α and ribavirin therapy were identified as independent factors for SVR. CONCLUSION: VR at week 6, but not at week 4, is an efficient predictor of both SVR and non-SVR to TVR-based triple therapy.

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