A phase 3b study of sofosbuvir plus ribavirin in treatment-naive and treatment-experienced Korean patients chronically infected with genotype 2 hepatitis C virus

SangHoon Ahn, Y. S. Lim, K. S. Lee, S. W. Paik, Y. J. Lee, S. H. Jeong, J. H. Kim, S. K. Yoon, H. J. Yim, W. Y. Tak, S. Y. Han, J. C. Yang, H. Mo, A. Mathias, L. Han, S. J. Knox, D. M. Brainard, Y. J. Kim, K. S. Byun, Y. S. Kim & 2 others J. Heo, KwangHyub Han

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Abstract

In Korea, patients with chronic hepatitis C virus (HCV) infection are typically treated with pegylated interferon-alpha plus ribavirin, but interferons are contraindicated in many patients and are often poorly tolerated, particularly by the elderly and those with advanced liver disease. No interferon-free treatment regimens are approved in Korea. Sofosbuvir is an oral nucleotide analog inhibitor of the HCV nonstructural 5B RNA polymerase. It is approved in the USA, European Union and Japan for treating a number of HCV genotypes, including genotype 2. Genotype 2 has a seroprevalence of 38-46% in Korea. This single-arm, phase 3b study (NCT02021643) examined the efficacy and safety of sofosbuvir plus ribavirin (12-week duration) in chronic genotype 2 HCV-infected treatment-naive and treatment-experienced Korean patients with and without cirrhosis. The proportion of patients with sustained virologic response 12 weeks after treatment discontinuation (SVR12) was 97% (125/129), with 96% (101/105) of treatment-naive and 100% (24/24) of treatment-experienced patients achieving SVR12. Two patients experienced virologic failure (n = 1, on-treatment failure; n = 1, relapse). No patient discontinued study treatment due to an adverse event (AE). The most common treatment-emergent AEs were headache (18%, 23/129) and pruritus (15%, 19/129). Few patients had grade 3 AEs (5%, 6/129) or grade 3 laboratory abnormalities (12%, 15/129). No grade 4 AE was reported. These data suggest that 12 weeks of treatment with the all-oral, interferon-free regimen of sofosbuvir plus ribavirin is effective and well tolerated in Korean patients with chronic genotype 2 HCV infection.

Original languageEnglish
Pages (from-to)358-365
Number of pages8
JournalJournal of Viral Hepatitis
Volume23
Issue number5
DOIs
Publication statusPublished - 2016 May 1

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Ribavirin
Hepacivirus
Genotype
Korea
Interferons
Therapeutics
Virus Diseases
Sofosbuvir
Seroepidemiologic Studies
Chronic Hepatitis C
European Union
DNA-Directed RNA Polymerases
Pruritus
Treatment Failure
Interferon-alpha
Headache
Liver Diseases
Japan
Fibrosis
Nucleotides

All Science Journal Classification (ASJC) codes

  • Hepatology
  • Infectious Diseases
  • Virology

Cite this

Ahn, SangHoon ; Lim, Y. S. ; 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. ; Mathias, A. ; Han, L. ; Knox, S. J. ; Brainard, D. M. ; Kim, Y. J. ; Byun, K. S. ; Kim, Y. S. ; Heo, J. ; Han, KwangHyub. / A phase 3b study of sofosbuvir plus ribavirin in treatment-naive and treatment-experienced Korean patients chronically infected with genotype 2 hepatitis C virus. In: Journal of Viral Hepatitis. 2016 ; Vol. 23, No. 5. pp. 358-365.
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abstract = "In Korea, patients with chronic hepatitis C virus (HCV) infection are typically treated with pegylated interferon-alpha plus ribavirin, but interferons are contraindicated in many patients and are often poorly tolerated, particularly by the elderly and those with advanced liver disease. No interferon-free treatment regimens are approved in Korea. Sofosbuvir is an oral nucleotide analog inhibitor of the HCV nonstructural 5B RNA polymerase. It is approved in the USA, European Union and Japan for treating a number of HCV genotypes, including genotype 2. Genotype 2 has a seroprevalence of 38-46{\%} in Korea. This single-arm, phase 3b study (NCT02021643) examined the efficacy and safety of sofosbuvir plus ribavirin (12-week duration) in chronic genotype 2 HCV-infected treatment-naive and treatment-experienced Korean patients with and without cirrhosis. The proportion of patients with sustained virologic response 12 weeks after treatment discontinuation (SVR12) was 97{\%} (125/129), with 96{\%} (101/105) of treatment-naive and 100{\%} (24/24) of treatment-experienced patients achieving SVR12. Two patients experienced virologic failure (n = 1, on-treatment failure; n = 1, relapse). No patient discontinued study treatment due to an adverse event (AE). The most common treatment-emergent AEs were headache (18{\%}, 23/129) and pruritus (15{\%}, 19/129). Few patients had grade 3 AEs (5{\%}, 6/129) or grade 3 laboratory abnormalities (12{\%}, 15/129). No grade 4 AE was reported. These data suggest that 12 weeks of treatment with the all-oral, interferon-free regimen of sofosbuvir plus ribavirin is effective and well tolerated in Korean patients with chronic genotype 2 HCV infection.",
author = "SangHoon Ahn and Lim, {Y. S.} and Lee, {K. S.} and Paik, {S. W.} and Lee, {Y. J.} and Jeong, {S. H.} and Kim, {J. H.} and Yoon, {S. K.} and Yim, {H. J.} and Tak, {W. Y.} and Han, {S. Y.} and Yang, {J. C.} and H. Mo and A. Mathias and L. Han and Knox, {S. J.} and Brainard, {D. M.} and Kim, {Y. J.} and Byun, {K. S.} and Kim, {Y. S.} and J. Heo and KwangHyub Han",
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Ahn, S, Lim, YS, Lee, KS, Paik, SW, Lee, YJ, Jeong, SH, Kim, JH, Yoon, SK, Yim, HJ, Tak, WY, Han, SY, Yang, JC, Mo, H, Mathias, A, Han, L, Knox, SJ, Brainard, DM, Kim, YJ, Byun, KS, Kim, YS, Heo, J & Han, K 2016, 'A phase 3b study of sofosbuvir plus ribavirin in treatment-naive and treatment-experienced Korean patients chronically infected with genotype 2 hepatitis C virus', Journal of Viral Hepatitis, vol. 23, no. 5, pp. 358-365. https://doi.org/10.1111/jvh.12499

A phase 3b study of sofosbuvir plus ribavirin in treatment-naive and treatment-experienced Korean patients chronically infected with genotype 2 hepatitis C virus. / Ahn, SangHoon; Lim, Y. S.; 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.; Mathias, A.; Han, L.; Knox, S. J.; Brainard, D. M.; Kim, Y. J.; Byun, K. S.; Kim, Y. S.; Heo, J.; Han, KwangHyub.

In: Journal of Viral Hepatitis, Vol. 23, No. 5, 01.05.2016, p. 358-365.

Research output: Contribution to journalArticle

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T1 - A phase 3b study of sofosbuvir plus ribavirin in treatment-naive and treatment-experienced Korean patients chronically infected with genotype 2 hepatitis C virus

AU - Ahn, SangHoon

AU - Lim, Y. S.

AU - Lee, K. S.

AU - Paik, S. W.

AU - Lee, Y. J.

AU - Jeong, S. H.

AU - Kim, J. H.

AU - Yoon, S. K.

AU - Yim, H. J.

AU - Tak, W. Y.

AU - Han, S. Y.

AU - Yang, J. C.

AU - Mo, H.

AU - Mathias, A.

AU - Han, L.

AU - Knox, S. J.

AU - Brainard, D. M.

AU - Kim, Y. J.

AU - Byun, K. S.

AU - Kim, Y. S.

AU - Heo, J.

AU - Han, KwangHyub

PY - 2016/5/1

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N2 - In Korea, patients with chronic hepatitis C virus (HCV) infection are typically treated with pegylated interferon-alpha plus ribavirin, but interferons are contraindicated in many patients and are often poorly tolerated, particularly by the elderly and those with advanced liver disease. No interferon-free treatment regimens are approved in Korea. Sofosbuvir is an oral nucleotide analog inhibitor of the HCV nonstructural 5B RNA polymerase. It is approved in the USA, European Union and Japan for treating a number of HCV genotypes, including genotype 2. Genotype 2 has a seroprevalence of 38-46% in Korea. This single-arm, phase 3b study (NCT02021643) examined the efficacy and safety of sofosbuvir plus ribavirin (12-week duration) in chronic genotype 2 HCV-infected treatment-naive and treatment-experienced Korean patients with and without cirrhosis. The proportion of patients with sustained virologic response 12 weeks after treatment discontinuation (SVR12) was 97% (125/129), with 96% (101/105) of treatment-naive and 100% (24/24) of treatment-experienced patients achieving SVR12. Two patients experienced virologic failure (n = 1, on-treatment failure; n = 1, relapse). No patient discontinued study treatment due to an adverse event (AE). The most common treatment-emergent AEs were headache (18%, 23/129) and pruritus (15%, 19/129). Few patients had grade 3 AEs (5%, 6/129) or grade 3 laboratory abnormalities (12%, 15/129). No grade 4 AE was reported. These data suggest that 12 weeks of treatment with the all-oral, interferon-free regimen of sofosbuvir plus ribavirin is effective and well tolerated in Korean patients with chronic genotype 2 HCV infection.

AB - In Korea, patients with chronic hepatitis C virus (HCV) infection are typically treated with pegylated interferon-alpha plus ribavirin, but interferons are contraindicated in many patients and are often poorly tolerated, particularly by the elderly and those with advanced liver disease. No interferon-free treatment regimens are approved in Korea. Sofosbuvir is an oral nucleotide analog inhibitor of the HCV nonstructural 5B RNA polymerase. It is approved in the USA, European Union and Japan for treating a number of HCV genotypes, including genotype 2. Genotype 2 has a seroprevalence of 38-46% in Korea. This single-arm, phase 3b study (NCT02021643) examined the efficacy and safety of sofosbuvir plus ribavirin (12-week duration) in chronic genotype 2 HCV-infected treatment-naive and treatment-experienced Korean patients with and without cirrhosis. The proportion of patients with sustained virologic response 12 weeks after treatment discontinuation (SVR12) was 97% (125/129), with 96% (101/105) of treatment-naive and 100% (24/24) of treatment-experienced patients achieving SVR12. Two patients experienced virologic failure (n = 1, on-treatment failure; n = 1, relapse). No patient discontinued study treatment due to an adverse event (AE). The most common treatment-emergent AEs were headache (18%, 23/129) and pruritus (15%, 19/129). Few patients had grade 3 AEs (5%, 6/129) or grade 3 laboratory abnormalities (12%, 15/129). No grade 4 AE was reported. These data suggest that 12 weeks of treatment with the all-oral, interferon-free regimen of sofosbuvir plus ribavirin is effective and well tolerated in Korean patients with chronic genotype 2 HCV infection.

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