Boceprevir Plus Peginterferon Alfa-2a/Ribavirin in Treatment-Naïve Hepatitis C Virus Genotype 1 Patients: International Phase IIIb/IV TriCo Trial

Peter Ferenci, Florin A. Caruntu, G. Lengyel, Diethelm Messinger, Georgios Bakalos, Robert Flisiak

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Introduction: Boceprevir was not previously studied with peginterferon alfa-2a/ribavirin in phase III trials in treatment-naïve chronic hepatitis C patients. The international phase IIIb/IV TriCo study was, therefore, designed to evaluate boceprevir in combination with peginterferon alfa-2a/ribavirin in treatment-naïve genotype 1 patients. Methods: A total of 165 treatment-naïve genotype 1 patients were assigned to boceprevir plus peginterferon alfa-2a/ribavirin therapy according to the label. All patients received a 4-week lead-in with peginterferon alfa-2a/ribavirin, after which boceprevir (2400 mg/day) was introduced. The total duration of treatment ranged from 28 to 48 weeks depending on the virological response at Weeks 4, 8, and 24, and on fibrosis status. The primary efficacy outcome was sustained virological response (SVR) [undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) 12 weeks after actual end of treatment, SVR12]. Results: The overall SVR12 rate was 81% (133/165, 95% confidence interval 74–86%). After 8 weeks of treatment, 61% of patients had undetectable HCV RNA, and 78 patients (47%) had an early response (undetectable HCV RNA at Weeks 8 and 24) and were eligible to stop all therapy at Week 28. Among early responders the SVR12 rate was 95% (74/78), and among patients with cirrhosis assigned to 48 weeks’ treatment, the SVR12 rate was 67% (14/21). The overall relapse rate was 7% (10/143), and was 4% (3/77) among early responders. The most common adverse events were anemia (41%), neutropenia (32%), and dysgeusia (31%). Conclusion: High SVR12 rates can be achieved with boceprevir plus peginterferon alfa-2a/ribavirin in treatment-naïve HCV genotype 1 patients, including patients with well-compensated cirrhosis. Treatment is well tolerated when label restrictions are taken into account. Trial Registration Number: ClinicalTrials.gov Identifier: NCT01591460. Funding: F. Hoffmann-La Roche Ltd.

Original languageEnglish
Pages (from-to)113-124
Number of pages12
JournalInfectious Diseases and Therapy
Volume5
Issue number2
DOIs
Publication statusPublished - Jun 1 2016

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Ribavirin
Hepacivirus
Genotype
Therapeutics
Fibrosis
RNA
peginterferon alfa-2a
N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide
Dysgeusia
Chronic Hepatitis C
Neutropenia
Anemia
Confidence Intervals
Recurrence

Keywords

  • Boceprevir
  • Chronic hepatitis C
  • Peginterferon alfa-2a
  • Ribavirin
  • Sustained virological response

ASJC Scopus subject areas

  • Infectious Diseases
  • Microbiology (medical)

Cite this

Boceprevir Plus Peginterferon Alfa-2a/Ribavirin in Treatment-Naïve Hepatitis C Virus Genotype 1 Patients : International Phase IIIb/IV TriCo Trial. / Ferenci, Peter; Caruntu, Florin A.; Lengyel, G.; Messinger, Diethelm; Bakalos, Georgios; Flisiak, Robert.

In: Infectious Diseases and Therapy, Vol. 5, No. 2, 01.06.2016, p. 113-124.

Research output: Contribution to journalArticle

Ferenci, Peter ; Caruntu, Florin A. ; Lengyel, G. ; Messinger, Diethelm ; Bakalos, Georgios ; Flisiak, Robert. / Boceprevir Plus Peginterferon Alfa-2a/Ribavirin in Treatment-Naïve Hepatitis C Virus Genotype 1 Patients : International Phase IIIb/IV TriCo Trial. In: Infectious Diseases and Therapy. 2016 ; Vol. 5, No. 2. pp. 113-124.
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abstract = "Introduction: Boceprevir was not previously studied with peginterferon alfa-2a/ribavirin in phase III trials in treatment-na{\"i}ve chronic hepatitis C patients. The international phase IIIb/IV TriCo study was, therefore, designed to evaluate boceprevir in combination with peginterferon alfa-2a/ribavirin in treatment-na{\"i}ve genotype 1 patients. Methods: A total of 165 treatment-na{\"i}ve genotype 1 patients were assigned to boceprevir plus peginterferon alfa-2a/ribavirin therapy according to the label. All patients received a 4-week lead-in with peginterferon alfa-2a/ribavirin, after which boceprevir (2400 mg/day) was introduced. The total duration of treatment ranged from 28 to 48 weeks depending on the virological response at Weeks 4, 8, and 24, and on fibrosis status. The primary efficacy outcome was sustained virological response (SVR) [undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) 12 weeks after actual end of treatment, SVR12]. Results: The overall SVR12 rate was 81{\%} (133/165, 95{\%} confidence interval 74–86{\%}). After 8 weeks of treatment, 61{\%} of patients had undetectable HCV RNA, and 78 patients (47{\%}) had an early response (undetectable HCV RNA at Weeks 8 and 24) and were eligible to stop all therapy at Week 28. Among early responders the SVR12 rate was 95{\%} (74/78), and among patients with cirrhosis assigned to 48 weeks’ treatment, the SVR12 rate was 67{\%} (14/21). The overall relapse rate was 7{\%} (10/143), and was 4{\%} (3/77) among early responders. The most common adverse events were anemia (41{\%}), neutropenia (32{\%}), and dysgeusia (31{\%}). Conclusion: High SVR12 rates can be achieved with boceprevir plus peginterferon alfa-2a/ribavirin in treatment-na{\"i}ve HCV genotype 1 patients, including patients with well-compensated cirrhosis. Treatment is well tolerated when label restrictions are taken into account. Trial Registration Number: ClinicalTrials.gov Identifier: NCT01591460. Funding: F. Hoffmann-La Roche Ltd.",
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AU - Caruntu, Florin A.

AU - Lengyel, G.

AU - Messinger, Diethelm

AU - Bakalos, Georgios

AU - Flisiak, Robert

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N2 - Introduction: Boceprevir was not previously studied with peginterferon alfa-2a/ribavirin in phase III trials in treatment-naïve chronic hepatitis C patients. The international phase IIIb/IV TriCo study was, therefore, designed to evaluate boceprevir in combination with peginterferon alfa-2a/ribavirin in treatment-naïve genotype 1 patients. Methods: A total of 165 treatment-naïve genotype 1 patients were assigned to boceprevir plus peginterferon alfa-2a/ribavirin therapy according to the label. All patients received a 4-week lead-in with peginterferon alfa-2a/ribavirin, after which boceprevir (2400 mg/day) was introduced. The total duration of treatment ranged from 28 to 48 weeks depending on the virological response at Weeks 4, 8, and 24, and on fibrosis status. The primary efficacy outcome was sustained virological response (SVR) [undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) 12 weeks after actual end of treatment, SVR12]. Results: The overall SVR12 rate was 81% (133/165, 95% confidence interval 74–86%). After 8 weeks of treatment, 61% of patients had undetectable HCV RNA, and 78 patients (47%) had an early response (undetectable HCV RNA at Weeks 8 and 24) and were eligible to stop all therapy at Week 28. Among early responders the SVR12 rate was 95% (74/78), and among patients with cirrhosis assigned to 48 weeks’ treatment, the SVR12 rate was 67% (14/21). The overall relapse rate was 7% (10/143), and was 4% (3/77) among early responders. The most common adverse events were anemia (41%), neutropenia (32%), and dysgeusia (31%). Conclusion: High SVR12 rates can be achieved with boceprevir plus peginterferon alfa-2a/ribavirin in treatment-naïve HCV genotype 1 patients, including patients with well-compensated cirrhosis. Treatment is well tolerated when label restrictions are taken into account. Trial Registration Number: ClinicalTrials.gov Identifier: NCT01591460. Funding: F. Hoffmann-La Roche Ltd.

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