Telaprevir twice daily is noninferior to telaprevir every 8 hours for patients with chronic hepatitis C

Maria Buti, Kosh Agarwal, Yves Horsmans, William Sievert, Ewa Janczewska, Stefan Zeuzem, Lisa Marie Nyberg, Robert S Brown Jr, Christophe Hezode, Mario Rizzetto, Raymundo Parana, Sandra De Meyer, Ralph J De Masi, Donghan Luo, Kirk Bertelsen, James Witek

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Abstract

BACKGROUND AIMS: We performed an open-label, multicenter, phase 3 study of the safety and efficacy of twice-daily telaprevir in treatment-naive patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those with cirrhosis. METHODS: Patients were randomly assigned to groups treated with telaprevir 1125 mg twice daily or 750 mg every 8 hours plus peginterferon alfa-2a and ribavirin for 12 weeks; patients were then treated with peginterferon alfa-2a and ribavirin alone for 12 weeks if their level of HCV RNA at week 4 was /=800,000 IU/mL, 28 had fibrosis (F3-F4), 14 had cirrhosis (F4), 57 were infected with HCV genotype 1a, and 71 had the non-CC IL28B genotype. Of patients who were treated with telaprevir twice daily, 74.3 achieved SVR12 compared with 72.8 of patients who were treated with telaprevir every 8 hours (difference in response, 1.5 ; 95 confidence interval, -4.9 to 12.0 ), so telaprevir twice daily is noninferior to telaprevir every 8 hours. All subgroups of patients who were treated with telaprevir twice daily versus those who were treated every 8 hours had similar rates of SVR12. The most frequent adverse events (AEs) in the telaprevir phase were fatigue (47 ), pruritus (43 ), anemia (42 ), nausea (37 ), rash (35 ), and headache (26 ); serious AEs were reported in 9 of patients. Rates of AEs and serious AEs were similar or slightly higher among patients treated with telaprevir every 8 hours. CONCLUSIONS: Based on a phase 3 trial, telaprevir twice daily is noninferior to every 8 hours in producing SVR12, with similar levels of safety and tolerability. These results support use of telaprevir twice daily in patients with chronic HCV genotype 1 infection, including those with cirrhosis. ClinicalTrials.gov, Number: NCT01241760.
Original languageEnglish
Pages (from-to)744 - 753 e3
Number of pages10
JournalGastroenterology
Volume146
Issue number3
DOIs
Publication statusPublished - 2014

Cite this

Buti, Maria ; Agarwal, Kosh ; Horsmans, Yves ; Sievert, William ; Janczewska, Ewa ; Zeuzem, Stefan ; Nyberg, Lisa Marie ; Brown Jr, Robert S ; Hezode, Christophe ; Rizzetto, Mario ; Parana, Raymundo ; De Meyer, Sandra ; De Masi, Ralph J ; Luo, Donghan ; Bertelsen, Kirk ; Witek, James. / Telaprevir twice daily is noninferior to telaprevir every 8 hours for patients with chronic hepatitis C. In: Gastroenterology. 2014 ; Vol. 146, No. 3. pp. 744 - 753 e3.
@article{26867cb2cceb4a648f9db0b0e05d0d92,
title = "Telaprevir twice daily is noninferior to telaprevir every 8 hours for patients with chronic hepatitis C",
abstract = "BACKGROUND AIMS: We performed an open-label, multicenter, phase 3 study of the safety and efficacy of twice-daily telaprevir in treatment-naive patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those with cirrhosis. METHODS: Patients were randomly assigned to groups treated with telaprevir 1125 mg twice daily or 750 mg every 8 hours plus peginterferon alfa-2a and ribavirin for 12 weeks; patients were then treated with peginterferon alfa-2a and ribavirin alone for 12 weeks if their level of HCV RNA at week 4 was /=800,000 IU/mL, 28 had fibrosis (F3-F4), 14 had cirrhosis (F4), 57 were infected with HCV genotype 1a, and 71 had the non-CC IL28B genotype. Of patients who were treated with telaprevir twice daily, 74.3 achieved SVR12 compared with 72.8 of patients who were treated with telaprevir every 8 hours (difference in response, 1.5 ; 95 confidence interval, -4.9 to 12.0 ), so telaprevir twice daily is noninferior to telaprevir every 8 hours. All subgroups of patients who were treated with telaprevir twice daily versus those who were treated every 8 hours had similar rates of SVR12. The most frequent adverse events (AEs) in the telaprevir phase were fatigue (47 ), pruritus (43 ), anemia (42 ), nausea (37 ), rash (35 ), and headache (26 ); serious AEs were reported in 9 of patients. Rates of AEs and serious AEs were similar or slightly higher among patients treated with telaprevir every 8 hours. CONCLUSIONS: Based on a phase 3 trial, telaprevir twice daily is noninferior to every 8 hours in producing SVR12, with similar levels of safety and tolerability. These results support use of telaprevir twice daily in patients with chronic HCV genotype 1 infection, including those with cirrhosis. ClinicalTrials.gov, Number: NCT01241760.",
author = "Maria Buti and Kosh Agarwal and Yves Horsmans and William Sievert and Ewa Janczewska and Stefan Zeuzem and Nyberg, {Lisa Marie} and {Brown Jr}, {Robert S} and Christophe Hezode and Mario Rizzetto and Raymundo Parana and {De Meyer}, Sandra and {De Masi}, {Ralph J} and Donghan Luo and Kirk Bertelsen and James Witek",
year = "2014",
doi = "10.1053/j.gastro.2013.11.047",
language = "English",
volume = "146",
pages = "744 -- 753 e3",
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Buti, M, Agarwal, K, Horsmans, Y, Sievert, W, Janczewska, E, Zeuzem, S, Nyberg, LM, Brown Jr, RS, Hezode, C, Rizzetto, M, Parana, R, De Meyer, S, De Masi, RJ, Luo, D, Bertelsen, K & Witek, J 2014, 'Telaprevir twice daily is noninferior to telaprevir every 8 hours for patients with chronic hepatitis C', Gastroenterology, vol. 146, no. 3, pp. 744 - 753 e3. https://doi.org/10.1053/j.gastro.2013.11.047

Telaprevir twice daily is noninferior to telaprevir every 8 hours for patients with chronic hepatitis C. / Buti, Maria; Agarwal, Kosh; Horsmans, Yves; Sievert, William; Janczewska, Ewa; Zeuzem, Stefan; Nyberg, Lisa Marie; Brown Jr, Robert S; Hezode, Christophe; Rizzetto, Mario; Parana, Raymundo; De Meyer, Sandra; De Masi, Ralph J; Luo, Donghan; Bertelsen, Kirk; Witek, James.

In: Gastroenterology, Vol. 146, No. 3, 2014, p. 744 - 753 e3.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Telaprevir twice daily is noninferior to telaprevir every 8 hours for patients with chronic hepatitis C

AU - Buti, Maria

AU - Agarwal, Kosh

AU - Horsmans, Yves

AU - Sievert, William

AU - Janczewska, Ewa

AU - Zeuzem, Stefan

AU - Nyberg, Lisa Marie

AU - Brown Jr, Robert S

AU - Hezode, Christophe

AU - Rizzetto, Mario

AU - Parana, Raymundo

AU - De Meyer, Sandra

AU - De Masi, Ralph J

AU - Luo, Donghan

AU - Bertelsen, Kirk

AU - Witek, James

PY - 2014

Y1 - 2014

N2 - BACKGROUND AIMS: We performed an open-label, multicenter, phase 3 study of the safety and efficacy of twice-daily telaprevir in treatment-naive patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those with cirrhosis. METHODS: Patients were randomly assigned to groups treated with telaprevir 1125 mg twice daily or 750 mg every 8 hours plus peginterferon alfa-2a and ribavirin for 12 weeks; patients were then treated with peginterferon alfa-2a and ribavirin alone for 12 weeks if their level of HCV RNA at week 4 was /=800,000 IU/mL, 28 had fibrosis (F3-F4), 14 had cirrhosis (F4), 57 were infected with HCV genotype 1a, and 71 had the non-CC IL28B genotype. Of patients who were treated with telaprevir twice daily, 74.3 achieved SVR12 compared with 72.8 of patients who were treated with telaprevir every 8 hours (difference in response, 1.5 ; 95 confidence interval, -4.9 to 12.0 ), so telaprevir twice daily is noninferior to telaprevir every 8 hours. All subgroups of patients who were treated with telaprevir twice daily versus those who were treated every 8 hours had similar rates of SVR12. The most frequent adverse events (AEs) in the telaprevir phase were fatigue (47 ), pruritus (43 ), anemia (42 ), nausea (37 ), rash (35 ), and headache (26 ); serious AEs were reported in 9 of patients. Rates of AEs and serious AEs were similar or slightly higher among patients treated with telaprevir every 8 hours. CONCLUSIONS: Based on a phase 3 trial, telaprevir twice daily is noninferior to every 8 hours in producing SVR12, with similar levels of safety and tolerability. These results support use of telaprevir twice daily in patients with chronic HCV genotype 1 infection, including those with cirrhosis. ClinicalTrials.gov, Number: NCT01241760.

AB - BACKGROUND AIMS: We performed an open-label, multicenter, phase 3 study of the safety and efficacy of twice-daily telaprevir in treatment-naive patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those with cirrhosis. METHODS: Patients were randomly assigned to groups treated with telaprevir 1125 mg twice daily or 750 mg every 8 hours plus peginterferon alfa-2a and ribavirin for 12 weeks; patients were then treated with peginterferon alfa-2a and ribavirin alone for 12 weeks if their level of HCV RNA at week 4 was /=800,000 IU/mL, 28 had fibrosis (F3-F4), 14 had cirrhosis (F4), 57 were infected with HCV genotype 1a, and 71 had the non-CC IL28B genotype. Of patients who were treated with telaprevir twice daily, 74.3 achieved SVR12 compared with 72.8 of patients who were treated with telaprevir every 8 hours (difference in response, 1.5 ; 95 confidence interval, -4.9 to 12.0 ), so telaprevir twice daily is noninferior to telaprevir every 8 hours. All subgroups of patients who were treated with telaprevir twice daily versus those who were treated every 8 hours had similar rates of SVR12. The most frequent adverse events (AEs) in the telaprevir phase were fatigue (47 ), pruritus (43 ), anemia (42 ), nausea (37 ), rash (35 ), and headache (26 ); serious AEs were reported in 9 of patients. Rates of AEs and serious AEs were similar or slightly higher among patients treated with telaprevir every 8 hours. CONCLUSIONS: Based on a phase 3 trial, telaprevir twice daily is noninferior to every 8 hours in producing SVR12, with similar levels of safety and tolerability. These results support use of telaprevir twice daily in patients with chronic HCV genotype 1 infection, including those with cirrhosis. ClinicalTrials.gov, Number: NCT01241760.

UR - http://www.sciencedirect.com/science/article/pii/S0016508513017289

U2 - 10.1053/j.gastro.2013.11.047

DO - 10.1053/j.gastro.2013.11.047

M3 - Article

VL - 146

SP - 744 - 753 e3

JO - Gastroenterology

JF - Gastroenterology

SN - 0016-5085

IS - 3

ER -