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

Research output: Contribution to journalArticle

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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 languageEnglish
Pages (from-to)947-955
Number of pages9
JournalHepatology International
Volume10
Issue number6
DOIs
Publication statusPublished - 2016 Nov 1

Fingerprint

Hepacivirus
Tablets
Genotype
Virus Diseases
Therapeutics
sofosbuvir drug combination ledipasvir
Ribavirin
Chronic Hepatitis C
European Union
Standard of Care
Korea
Treatment Failure
Interferon-alpha
Fatigue
Headache
Mouth
Japan
Fibrosis
Safety

Keywords

  • Genotype 1
  • Hepatitis C virus (HCV)
  • Korea
  • Ledipasvir
  • Sofosbuvir

ASJC Scopus subject areas

  • Hepatology

Cite this

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

In: Hepatology International, Vol. 10, No. 6, 01.11.2016, p. 947-955.

Research output: Contribution to journalArticle

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
Lim, Young Suk ; Ahn, Sang Hoon ; Lee, Kwan Sik ; Paik, Seung Woon ; Lee, Youn Jae ; Jeong, Sook Hyang ; Kim, Ju Hyun ; Yoon, Seung Kew ; Yim, Hyung Joon ; Tak, Won Young ; Han, Sang Young ; Yang, Jenny C. ; Mo, Hongmei ; Garrison, Kimberly L. ; Gao, Bing ; Knox, Steven J. ; Pang, Phillip S. ; Kim, Yoon Jun ; Byun, Kwan Soo ; Kim, Young Seok ; Heo, Jeong ; Han, Kwang Hyub. / 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. In: Hepatology International. 2016 ; Vol. 10, No. 6. pp. 947-955.
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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

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.

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KW - Genotype 1

KW - Hepatitis C virus (HCV)

KW - Korea

KW - Ledipasvir

KW - Sofosbuvir

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