Ledipasvir/sofosbuvir fixed-dose combination tablet in Taiwanese patients with chronic genotype 1 hepatitis C virus

Wan Long Chuang, Rong Nan Chien, Cheng Yuan Peng, Ting Tsung Chang, Gin Ho Lo, I. Shyan Sheen, Horng Yuan Wang, Jyh Jou Chen, Jenny C. Yang, Steven J. Knox, Bing Gao, Kimberly L. Garrison, Hongmei Mo, Phillip S. Pang, Yu Chun Hsu, Tsung Hui Hu, Chi Jen Chu, Jia Horng Kao

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Abstract

Background and Aim:: Pegylated-interferon-alpha plus ribavirin is the current standard-of-care regimen for treating chronic hepatitis C virus (HCV) infection in Taiwan; however, interferon-based regimens can be poorly tolerated. The interferon-free, two-drug, fixed-dose combination tablet ledipasvir/sofosbuvir is approved in Europe, the USA, and Japan for treating chronic genotype 1 HCV infection. Little is known about its efficacy/safety in Taiwanese patients. Methods:: In this multicenter, open-label, phase 3b (NCT02021656) study, 85 Taiwanese patients (n = 42, treatment-naïve; n = 43, treatment-experienced) with chronic genotype 1 HCV infection (±compensated cirrhosis) received 12 weeks of ledipasvir/sofosbuvir fixed-dose combination tablet. The primary efficacy end point was the proportion of patients with sustained virologic response 12 weeks after treatment discontinuation (SVR12). Safety and pharmacokinetic data were collected. Results:: The overall SVR12 rate was 98% (83/85), with 100% (42/42) and 95% (41/43) of treatment-naïve and treatment-experienced patients, respectively, achieving SVR12. There were no on-treatment virologic failures. One patient relapsed after treatment discontinuation; one patient withdrew consent on day 2. The most common treatment-emergent adverse event (AE) was headache (14%, 12/85). There was one grade 3 AE (small cell lung cancer unrelated to ledipasvir/sofosbuvir), no grade 4 AEs, and four grade 3–4 laboratory abnormalities. Only the patient with small cell lung cancer prematurely discontinued treatment. Two patients reported three serious AEs; none was considered related to ledipasvir/sofosbuvir. Conclusions:: Data from this phase 3b study suggest that 12 weeks of once-daily treatment with the interferon-free, ribavirin-free regimen ledipasvir/sofosbuvir is effective and well-tolerated in Taiwanese patients with chronic genotype 1 HCV infection, irrespective of treatment history.

Original languageEnglish
Pages (from-to)1323-1329
Number of pages7
JournalJournal of Gastroenterology and Hepatology (Australia)
Volume31
Issue number7
DOIs
Publication statusPublished - 2016 Jul 1

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All Science Journal Classification (ASJC) codes

  • Hepatology
  • Gastroenterology

Cite this

Chuang, W. L., Chien, R. N., Peng, C. Y., Chang, T. T., Lo, G. H., Sheen, I. S., Wang, H. Y., Chen, J. J., Yang, J. C., Knox, S. J., Gao, B., Garrison, K. L., Mo, H., Pang, P. S., Hsu, Y. C., Hu, T. H., Chu, C. J., & Kao, J. H. (2016). Ledipasvir/sofosbuvir fixed-dose combination tablet in Taiwanese patients with chronic genotype 1 hepatitis C virus. Journal of Gastroenterology and Hepatology (Australia), 31(7), 1323-1329. https://doi.org/10.1111/jgh.13305