Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2016 Apr;51(4):390-403.
doi: 10.1007/s00535-015-1120-x. Epub 2015 Sep 25.

Vaniprevir plus peginterferon alfa-2b and ribavirin in treatment-naive Japanese patients with hepatitis C virus genotype 1 infection: a randomized phase III study

Norio Hayashi  1 , Makoto Nakamuta  2 , Tetsuo Takehara  3 , Hiromitsu Kumada  4 , Akiko Takase  5 , Anita Yee Mei Howe  6 , Steven W Ludmerer  6 , Niloufar Mobashery  6
Affiliations
Clinical Trial

Vaniprevir plus peginterferon alfa-2b and ribavirin in treatment-naive Japanese patients with hepatitis C virus genotype 1 infection: a randomized phase III study

Norio Hayashi et al. J Gastroenterol. 2016 Apr.

Abstract

Background: Vaniprevir is a potent macrocyclic hepatitis C virus (HCV) nonstructural protein 3/4A protease inhibitor. This phase III study evaluated the safety and efficacy of vaniprevir in combination with peginterferon alfa-2b and ribavirin (PR) for 24 weeks compared with PR alone for 48 weeks in treatment-naive Japanese patients with HCV genotype 1 infection.

Methods: Treatment-naive Japanese patients with HCV genotype 1 infection were randomly assigned to receive vaniprevir (300 mg twice daily) plus PR for 12 weeks then PR alone for 12 weeks, vaniprevir (300 mg twice daily) plus PR for 24 weeks, or PR alone for 48 weeks. The primary end point was sustained virologic response 24 weeks after completion of treatment (SVR24).

Results: In total, 294 patients were randomly assigned to receive treatment. Most patients had HCV genotype 1b infection (98 %, 288 of 294 patients). SVR24 was achieved in 83.7, 84.5, and 55.1 % of the patients in the vaniprevir 12-week, vaniprevir 24-week, and control arms, respectively. The difference in SVR24 rates between each vaniprevir arm and the control arm was statistically significant (p < 0.001 for both). Relapse was commoner in the control arm (29.5 %) than in the vaniprevir arms (8.6 % and 10.5 % for the 12-week and 24-week arms, respectively). Commonly reported adverse events were generally similar across treatment arms, with the exception of an increase in the incidence of gastrointestinal adverse events such as nausea, diarrhea, and vomiting in patients receiving vaniprevir. These events were considered manageable.

Conclusion: Vaniprevir is a valuable addition to the therapeutic options available to Japanese patients with HCV genotype 1 infection who are eligible for interferon-based treatment. CLINICALTRIALS.

Gov identifier: NCT01370642.

Keywords: Hepatitis C virus; Japan; Peginterferon; Ribavirin; Vaniprevir.

PubMed Disclaimer

Figures

Fig. 1
Fig. 1
Study disposition. HCV hepatitis C virus
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

References

    1. Chung H, Ueda T, Kudo M. Changing trends in hepatitis C infection over the past 50 years in Japan. Intervirology. 2010;53(1):39–43. doi: 10.1159/000252782. - DOI - PubMed
    1. American Association for the Study of Liver Diseases, Infectious Diseases Society of America. Recommendations for testing, managing, and treating hepatitis C. http://www.hcvguidelines.org (2014). Accessed 26 May 2015. - PMC - PubMed
    1. European Association for the Study of the Liver EASL clinical practice guidelines: management of hepatitis C virus infection. J Hepatol. 2014;60(2):392–420. doi: 10.1016/j.jhep.2013.11.003. - DOI - PubMed
    1. Lemoine M, Thursz M. Hepatitis C, a global issue: access to care and new therapeutic and preventive approaches in resource-constrained areas. Semin Liver Dis. 2014;34(1):89–97. doi: 10.1055/s-0034-1371082. - DOI - PubMed
    1. Hayashi N, Izumi N, Kumada H, et al. Simeprevir with peginterferon/ribavirin for treatment-naive hepatitis C genotype 1 patients in Japan: CONCERTO-1, a phase III trial. J Hepatol. 2014;61(2):219–227. doi: 10.1016/j.jhep.2014.04.004. - DOI - PubMed

MeSH terms

Associated data