A phase IIIb study of ledipasvir/sofosbuvir fixed-dose combination tablet in treatment-naïve and treatment-experienced Korean patients chronically infected with genotype 1 hepatitis C virus

Young Suk Lim; Sang Hoon Ahn; Kwan Sik Lee; Seung Woon Paik; Youn Jae Lee; Sook Hyang Jeong; Ju Hyun Kim; Seung Kew Yoon; Hyung Joon Yim; Won Young Tak; Sang Young Han; Jenny C. Yang; Hongmei Mo; Kimberly L. Garrison; Bing Gao; Steven J. Knox; Phillip S. Pang; Yoon Jun Kim; Kwan Soo Byun; Young Seok Kim; Jeong Heo; Kwang Hyub Han

doi:10.1007/s12072-016-9726-5

A phase IIIb study of ledipasvir/sofosbuvir fixed-dose combination tablet in treatment-naïve and treatment-experienced Korean patients chronically infected with genotype 1 hepatitis C virus

Young Suk Lim, Sang Hoon Ahn, Kwan Sik Lee, Seung Woon Paik, Youn Jae Lee, Sook Hyang Jeong, Ju Hyun Kim, Seung Kew Yoon, Hyung Joon Yim, Won Young Tak, Sang Young Han, Jenny C. Yang, Hongmei Mo, Kimberly L. Garrison, Bing Gao, Steven J. Knox, Phillip S. Pang, Yoon Jun Kim, Kwan Soo Byun, Young Seok KimJeong Heo, Kwang Hyub Han

Department of Internal Medicine

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

15 Citations (Scopus)

Abstract

Background: The standard-of-care regimen for chronic hepatitis C virus (HCV) infection in Korea, pegylated-interferon-alpha plus ribavirin, is poorly tolerated. Ledipasvir/sofosbuvir is a two-drug, fixed-dose combination tablet approved in the USA, European Union, and Japan for chronic genotype 1 HCV infection. Methods: This single-arm, phase IIIb study (NCT02021656) investigated the efficacy and safety of ledipasvir/sofosbuvir fixed-dose combination tablet for 12 weeks in treatment-naïve and treatment-experienced Korean patients chronically infected with genotype 1 HCV with or without compensated cirrhosis. Results: The proportion of patients with sustained virologic response 12 weeks after treatment discontinuation (SVR12) was 99 % (92/93), with rates of 100 % (46/46) and 98 % (46/47) in treatment-naïve and treatment-experienced patients, respectively. There were no on-treatment failures. One patient relapsed after the end of treatment. The most common treatment-emergent adverse events were headache (8 %, 7/93) and fatigue (6 %, 6/93). There were no grade 3 or 4 adverse events, seven grade 3 laboratory abnormalities, and one premature discontinuation of study treatment (due to nonserious mouth ulceration). None of the three reported serious adverse events were related to treatment. Conclusions: These data suggest that 12 weeks of ledipasvir/sofosbuvir is effective and well tolerated in treatment-naïve and treatment-experienced Korean patients with chronic genotype 1 HCV infection.

Original language	English
Pages (from-to)	947-955
Number of pages	9
Journal	Hepatology International
Volume	10
Issue number	6
DOIs	https://doi.org/10.1007/s12072-016-9726-5
Publication status	Published - 2016 Nov 1

Bibliographical note

Funding Information:
This study was funded in full by Gilead Sciences, Inc. The writing and preparation of this paper were funded by Gilead Sciences, Inc. The initial data analyses were undertaken by the listed authors. Writing support was provided by Tiffany DeSimone, PhD, of BlueMomentum, an Ashfield Company, part of UDG Healthcare plc, and funded by Gilead Sciences, Inc.

Publisher Copyright:
© 2016, Asian Pacific Association for the Study of the Liver.

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Hepatology

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10.1007/s12072-016-9726-5

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Lim, Y. S., Ahn, S. H., Lee, K. S., Paik, S. W., Lee, Y. J., Jeong, S. H., Kim, J. H., Yoon, S. K., Yim, H. J., Tak, W. Y., Han, S. Y., Yang, J. C., Mo, H., Garrison, K. L., Gao, B., Knox, S. J., Pang, P. S., Kim, Y. J., Byun, K. S., ... Han, K. H. (2016). A phase IIIb study of ledipasvir/sofosbuvir fixed-dose combination tablet in treatment-naïve and treatment-experienced Korean patients chronically infected with genotype 1 hepatitis C virus. Hepatology International, 10(6), 947-955. https://doi.org/10.1007/s12072-016-9726-5

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title = "A phase IIIb study of ledipasvir/sofosbuvir fixed-dose combination tablet in treatment-na{\"i}ve and treatment-experienced Korean patients chronically infected with genotype 1 hepatitis C virus",

abstract = "Background: The standard-of-care regimen for chronic hepatitis C virus (HCV) infection in Korea, pegylated-interferon-alpha plus ribavirin, is poorly tolerated. Ledipasvir/sofosbuvir is a two-drug, fixed-dose combination tablet approved in the USA, European Union, and Japan for chronic genotype 1 HCV infection. Methods: This single-arm, phase IIIb study (NCT02021656) investigated the efficacy and safety of ledipasvir/sofosbuvir fixed-dose combination tablet for 12 weeks in treatment-na{\"i}ve and treatment-experienced Korean patients chronically infected with genotype 1 HCV with or without compensated cirrhosis. Results: The proportion of patients with sustained virologic response 12 weeks after treatment discontinuation (SVR12) was 99 % (92/93), with rates of 100 % (46/46) and 98 % (46/47) in treatment-na{\"i}ve and treatment-experienced patients, respectively. There were no on-treatment failures. One patient relapsed after the end of treatment. The most common treatment-emergent adverse events were headache (8 %, 7/93) and fatigue (6 %, 6/93). There were no grade 3 or 4 adverse events, seven grade 3 laboratory abnormalities, and one premature discontinuation of study treatment (due to nonserious mouth ulceration). None of the three reported serious adverse events were related to treatment. Conclusions: These data suggest that 12 weeks of ledipasvir/sofosbuvir is effective and well tolerated in treatment-na{\"i}ve and treatment-experienced Korean patients with chronic genotype 1 HCV infection.",

author = "Lim, {Young Suk} and Ahn, {Sang Hoon} and Lee, {Kwan Sik} and Paik, {Seung Woon} and Lee, {Youn Jae} and Jeong, {Sook Hyang} and Kim, {Ju Hyun} and Yoon, {Seung Kew} and Yim, {Hyung Joon} and Tak, {Won Young} and Han, {Sang Young} and Yang, {Jenny C.} and Hongmei Mo and Garrison, {Kimberly L.} and Bing Gao and Knox, {Steven J.} and Pang, {Phillip S.} and Kim, {Yoon Jun} and Byun, {Kwan Soo} and Kim, {Young Seok} and Jeong Heo and Han, {Kwang Hyub}",

note = "Funding Information: This study was funded in full by Gilead Sciences, Inc. The writing and preparation of this paper were funded by Gilead Sciences, Inc. The initial data analyses were undertaken by the listed authors. Writing support was provided by Tiffany DeSimone, PhD, of BlueMomentum, an Ashfield Company, part of UDG Healthcare plc, and funded by Gilead Sciences, Inc. Publisher Copyright: {\textcopyright} 2016, Asian Pacific Association for the Study of the Liver.",

year = "2016",

month = nov,

day = "1",

doi = "10.1007/s12072-016-9726-5",

language = "English",

volume = "10",

pages = "947--955",

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Lim, YS, Ahn, SH, Lee, KS, Paik, SW, Lee, YJ, Jeong, SH, Kim, JH, Yoon, SK, Yim, HJ, Tak, WY, Han, SY, Yang, JC, Mo, H, Garrison, KL, Gao, B, Knox, SJ, Pang, PS, Kim, YJ, Byun, KS, Kim, YS, Heo, J & Han, KH 2016, 'A phase IIIb study of ledipasvir/sofosbuvir fixed-dose combination tablet in treatment-naïve and treatment-experienced Korean patients chronically infected with genotype 1 hepatitis C virus', Hepatology International, vol. 10, no. 6, pp. 947-955. https://doi.org/10.1007/s12072-016-9726-5

A phase IIIb study of ledipasvir/sofosbuvir fixed-dose combination tablet in treatment-naïve and treatment-experienced Korean patients chronically infected with genotype 1 hepatitis C virus. / Lim, Young Suk; Ahn, Sang Hoon; Lee, Kwan Sik et al.
In: Hepatology International, Vol. 10, No. 6, 01.11.2016, p. 947-955.

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

TY - JOUR

T1 - A phase IIIb study of ledipasvir/sofosbuvir fixed-dose combination tablet in treatment-naïve and treatment-experienced Korean patients chronically infected with genotype 1 hepatitis C virus

AU - Lim, Young Suk

AU - Ahn, Sang Hoon

AU - Lee, Kwan Sik

AU - Paik, Seung Woon

AU - Lee, Youn Jae

AU - Jeong, Sook Hyang

AU - Kim, Ju Hyun

AU - Yoon, Seung Kew

AU - Yim, Hyung Joon

AU - Tak, Won Young

AU - Han, Sang Young

AU - Yang, Jenny C.

AU - Mo, Hongmei

AU - Garrison, Kimberly L.

AU - Gao, Bing

AU - Knox, Steven J.

AU - Pang, Phillip S.

AU - Kim, Yoon Jun

AU - Byun, Kwan Soo

AU - Kim, Young Seok

AU - Heo, Jeong

AU - Han, Kwang Hyub

N1 - Funding Information: This study was funded in full by Gilead Sciences, Inc. The writing and preparation of this paper were funded by Gilead Sciences, Inc. The initial data analyses were undertaken by the listed authors. Writing support was provided by Tiffany DeSimone, PhD, of BlueMomentum, an Ashfield Company, part of UDG Healthcare plc, and funded by Gilead Sciences, Inc. Publisher Copyright: © 2016, Asian Pacific Association for the Study of the Liver.

PY - 2016/11/1

Y1 - 2016/11/1

N2 - Background: The standard-of-care regimen for chronic hepatitis C virus (HCV) infection in Korea, pegylated-interferon-alpha plus ribavirin, is poorly tolerated. Ledipasvir/sofosbuvir is a two-drug, fixed-dose combination tablet approved in the USA, European Union, and Japan for chronic genotype 1 HCV infection. Methods: This single-arm, phase IIIb study (NCT02021656) investigated the efficacy and safety of ledipasvir/sofosbuvir fixed-dose combination tablet for 12 weeks in treatment-naïve and treatment-experienced Korean patients chronically infected with genotype 1 HCV with or without compensated cirrhosis. Results: The proportion of patients with sustained virologic response 12 weeks after treatment discontinuation (SVR12) was 99 % (92/93), with rates of 100 % (46/46) and 98 % (46/47) in treatment-naïve and treatment-experienced patients, respectively. There were no on-treatment failures. One patient relapsed after the end of treatment. The most common treatment-emergent adverse events were headache (8 %, 7/93) and fatigue (6 %, 6/93). There were no grade 3 or 4 adverse events, seven grade 3 laboratory abnormalities, and one premature discontinuation of study treatment (due to nonserious mouth ulceration). None of the three reported serious adverse events were related to treatment. Conclusions: These data suggest that 12 weeks of ledipasvir/sofosbuvir is effective and well tolerated in treatment-naïve and treatment-experienced Korean patients with chronic genotype 1 HCV infection.

AB - Background: The standard-of-care regimen for chronic hepatitis C virus (HCV) infection in Korea, pegylated-interferon-alpha plus ribavirin, is poorly tolerated. Ledipasvir/sofosbuvir is a two-drug, fixed-dose combination tablet approved in the USA, European Union, and Japan for chronic genotype 1 HCV infection. Methods: This single-arm, phase IIIb study (NCT02021656) investigated the efficacy and safety of ledipasvir/sofosbuvir fixed-dose combination tablet for 12 weeks in treatment-naïve and treatment-experienced Korean patients chronically infected with genotype 1 HCV with or without compensated cirrhosis. Results: The proportion of patients with sustained virologic response 12 weeks after treatment discontinuation (SVR12) was 99 % (92/93), with rates of 100 % (46/46) and 98 % (46/47) in treatment-naïve and treatment-experienced patients, respectively. There were no on-treatment failures. One patient relapsed after the end of treatment. The most common treatment-emergent adverse events were headache (8 %, 7/93) and fatigue (6 %, 6/93). There were no grade 3 or 4 adverse events, seven grade 3 laboratory abnormalities, and one premature discontinuation of study treatment (due to nonserious mouth ulceration). None of the three reported serious adverse events were related to treatment. Conclusions: These data suggest that 12 weeks of ledipasvir/sofosbuvir is effective and well tolerated in treatment-naïve and treatment-experienced Korean patients with chronic genotype 1 HCV infection.

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JO - Hepatology International

JF - Hepatology International

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ER -

A phase IIIb study of ledipasvir/sofosbuvir fixed-dose combination tablet in treatment-naïve and treatment-experienced Korean patients chronically infected with genotype 1 hepatitis C virus

Abstract

Bibliographical note

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