Safety and efficacy of elbasvir/grazoprevir in Asian participants with hepatitis C virus genotypes 1 and 4 infection

Lai Wei, Hiromitsu Kumada, Ponni V. Perumalswami, Tawesak Tanwandee, Wendy Cheng, Jeong Heo, Pin Nan Cheng, Peggy Hwang, Sheng Mei Mu, Xu Min Zhao, Ernest Asante-Appiah, Luzelena Caro, George J. Hanna, Michael N. Robertson, Barbara A. Haber, Rohit Talwani

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Abstract

Background and Aim: Estimates suggest that in Asia, more than 31 million individuals have hepatitis C virus infection. The present analysis was conducted to assess the efficacy and safety of elbasvir/grazoprevir in Asian participants enrolled in the elbasvir/grazoprevir phase 2/3 clinical trials. Methods: This is an integrated analysis of data from 12 international phase 2/3 clinical trials. Asian participants with chronic hepatitis C virus genotype 1 or 4 infection who received elbasvir 50 mg/grazoprevir 100 mg once daily for 12 weeks or elbasvir/grazoprevir plus ribavirin for 16 weeks were included in this analysis. The primary end point was sustained virologic response at 12 weeks after completion of therapy (SVR12). Results: Seven hundred eighty Asian participants from 15 countries were included in this analysis. SVR12 was achieved by 756/780 (96.9%) of all participants, including 748/772 (96.9%) of those who received elbasvir/grazoprevir for 12 weeks and 8/8 (100%) of those who received elbasvir/grazoprevir plus ribavirin for 16 weeks. In the genotype 1b-infected population, the SVR12 rate was 691/709 (97.5%), and there was no impact of age, high baseline viral load, or presence of cirrhosis. The most frequently reported adverse events were nasopharyngitis (8.0%), upper respiratory tract infection (5.4%), and diarrhea (5.2%). Twenty participants receiving elbasvir/grazoprevir for 12 weeks reported a total of 25 serious adverse events, and 7 (0.9%) discontinued treatment because of an adverse event. Conclusion: Elbasvir/grazoprevir administered for 12 weeks is an effective and generally well-tolerated treatment option for Asian individuals with hepatitis C virus genotype 1b infection.

Original languageEnglish
Pages (from-to)1597-1603
Number of pages7
JournalJournal of Gastroenterology and Hepatology (Australia)
Volume34
Issue number9
DOIs
Publication statusPublished - 2019 Sep 1

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All Science Journal Classification (ASJC) codes

  • Hepatology
  • Gastroenterology

Cite this

Wei, L., Kumada, H., Perumalswami, P. V., Tanwandee, T., Cheng, W., Heo, J., Cheng, P. N., Hwang, P., Mu, S. M., Zhao, X. M., Asante-Appiah, E., Caro, L., Hanna, G. J., Robertson, M. N., Haber, B. A., & Talwani, R. (2019). Safety and efficacy of elbasvir/grazoprevir in Asian participants with hepatitis C virus genotypes 1 and 4 infection. Journal of Gastroenterology and Hepatology (Australia), 34(9), 1597-1603. https://doi.org/10.1111/jgh.14636