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

doi:10.1111/jgh.13305

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^*

^*Corresponding author for this work

School of Medicine

Research output: Contribution to journal › Journal Article › peer-review

25 Scopus citations

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 language	English
Pages (from-to)	1323-1329
Number of pages	7
Journal	Journal of Gastroenterology and Hepatology (Australia)
Volume	31
Issue number	7
DOIs	https://doi.org/10.1111/jgh.13305
State	Published - 01 07 2016

Bibliographical note

Publisher Copyright:
© 2016 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd

Keywords

Taiwan
hepatitis C virus (HCV)
infection
ledipasvir
sofosbuvir

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1111/jgh.13305

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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

@article{42952e15c05141df83880e1a64d9cedd,

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

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-na{\"i}ve; 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-na{\"i}ve 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.",

keywords = "Taiwan, hepatitis C virus (HCV), infection, ledipasvir, sofosbuvir",

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

note = "Publisher Copyright: {\textcopyright} 2016 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd",

year = "2016",

month = jul,

day = "1",

doi = "10.1111/jgh.13305",

language = "英语",

volume = "31",

pages = "1323--1329",

journal = "Journal of Gastroenterology and Hepatology (Australia)",

issn = "0815-9319",

publisher = "Wiley-Blackwell Publishing Ltd",

number = "7",

}

Chuang, WL, Chien, RN, Peng, CY, Chang, TT, Lo, GH, Sheen, IS, Wang, HY, Chen, JJ, Yang, JC, Knox, SJ, Gao, B, Garrison, KL, Mo, H, Pang, PS, Hsu, YC, Hu, TH, Chu, CJ & Kao, JH 2016, 'Ledipasvir/sofosbuvir fixed-dose combination tablet in Taiwanese patients with chronic genotype 1 hepatitis C virus', Journal of Gastroenterology and Hepatology (Australia), vol. 31, no. 7, pp. 1323-1329. https://doi.org/10.1111/jgh.13305

TY - JOUR

T1 - Ledipasvir/sofosbuvir fixed-dose combination tablet in Taiwanese patients with chronic genotype 1 hepatitis C virus

AU - Chuang, Wan Long

AU - Chien, Rong Nan

AU - Peng, Cheng Yuan

AU - Chang, Ting Tsung

AU - Lo, Gin Ho

AU - Sheen, I. Shyan

AU - Wang, Horng Yuan

AU - Chen, Jyh Jou

AU - Yang, Jenny C.

AU - Knox, Steven J.

AU - Gao, Bing

AU - Garrison, Kimberly L.

AU - Mo, Hongmei

AU - Pang, Phillip S.

AU - Hsu, Yu Chun

AU - Hu, Tsung Hui

AU - Chu, Chi Jen

AU - Kao, Jia Horng

PY - 2016/7/1

Y1 - 2016/7/1

N2 - 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.

AB - 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.

KW - Taiwan

KW - hepatitis C virus (HCV)

KW - infection

KW - ledipasvir

KW - sofosbuvir

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U2 - 10.1111/jgh.13305

DO - 10.1111/jgh.13305

M3 - 文章

C2 - 26841930

AN - SCOPUS:84979523519

SN - 0815-9319

VL - 31

SP - 1323

EP - 1329

JO - Journal of Gastroenterology and Hepatology (Australia)

JF - Journal of Gastroenterology and Hepatology (Australia)

IS - 7

ER -

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

Abstract

Bibliographical note

Keywords

UN SDGs

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