Real-life effectiveness and safety of the daclatasvir/asunaprevir combination therapy for genotype 1b chronic hepatitis C patients: An emphasis on the pretreatment NS5A resistance-associated substitution test

Eun Sun Jang, Kyung Ah Kim, Young Seok Kim, In Hee Kim, Byung Seok Lee, Youn Jae Lee, Woo Jin Chung, Sook Hyang Jeong

Research output: Contribution to journalArticle

Abstract

This study aimed to investigate the real-life effectiveness and safety of daclatasvir (DCV) and asunaprevir (ASV) combination therapy in Korean patients. We consecutively enrolled patients with genotype 1b hepatitis C virus (HCV) infection treated with at least one dose of DCV/ASV combination therapy in seven tertiary hospitals of South Korea. The sustained virologic response (SVR) rates and safety according to intention-to-treat (ITT) and per-protocol (PP) analyses were evaluated. Among the 526 enrolled patients, 91% showed negative (87%) or “undetermined” (4%) resistance-associated substitution (RAS); 9% did not undergo RAS testing. The SVR rates for ITT and PP were 89.3% and 95.0% in treatment-naive patients and 93.2% and 95.6% in treatment-experienced patients, respectively. In PP analysis, negative RAS was associated with higher SVR (96.3%) than with “undetermined RAS” (85.7%) or “not tested for RAS” (84.4%). Adverse events were reported in 185 (35.4%) patients, and events leading to discontinuation were observed in 4.3% of the study population. Forty-two (8.0%) patients developed transaminase elevation (≥2 × upper normal limit), resulting in treatment discontinuation in six (1.1%) patients. DCV/ASV combination therapy showed acceptable efficacy in genotype 1b compensated HCV-infected patients with negative pretreatment RAS. Although most adverse events were tolerable to continue antiviral treatment, adequate monitoring for transaminase elevation is warranted.

Original languageEnglish
Pages (from-to)2158-2165
Number of pages8
JournalJournal of Medical Virology
Volume91
Issue number12
DOIs
StatePublished - 1 Dec 2019

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Chronic Hepatitis C
Genotype
Safety
Therapeutics
Transaminases
Hepacivirus
BMS-790052
asunaprevir
Republic of Korea
Virus Diseases
Tertiary Care Centers
Antiviral Agents

Keywords

  • anti-hepatitis C virus DAA
  • antisense drug resistance
  • antiviral agents
  • hepatitis C virus

Cite this

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title = "Real-life effectiveness and safety of the daclatasvir/asunaprevir combination therapy for genotype 1b chronic hepatitis C patients: An emphasis on the pretreatment NS5A resistance-associated substitution test",
abstract = "This study aimed to investigate the real-life effectiveness and safety of daclatasvir (DCV) and asunaprevir (ASV) combination therapy in Korean patients. We consecutively enrolled patients with genotype 1b hepatitis C virus (HCV) infection treated with at least one dose of DCV/ASV combination therapy in seven tertiary hospitals of South Korea. The sustained virologic response (SVR) rates and safety according to intention-to-treat (ITT) and per-protocol (PP) analyses were evaluated. Among the 526 enrolled patients, 91{\%} showed negative (87{\%}) or “undetermined” (4{\%}) resistance-associated substitution (RAS); 9{\%} did not undergo RAS testing. The SVR rates for ITT and PP were 89.3{\%} and 95.0{\%} in treatment-naive patients and 93.2{\%} and 95.6{\%} in treatment-experienced patients, respectively. In PP analysis, negative RAS was associated with higher SVR (96.3{\%}) than with “undetermined RAS” (85.7{\%}) or “not tested for RAS” (84.4{\%}). Adverse events were reported in 185 (35.4{\%}) patients, and events leading to discontinuation were observed in 4.3{\%} of the study population. Forty-two (8.0{\%}) patients developed transaminase elevation (≥2 × upper normal limit), resulting in treatment discontinuation in six (1.1{\%}) patients. DCV/ASV combination therapy showed acceptable efficacy in genotype 1b compensated HCV-infected patients with negative pretreatment RAS. Although most adverse events were tolerable to continue antiviral treatment, adequate monitoring for transaminase elevation is warranted.",
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author = "Jang, {Eun Sun} and Kim, {Kyung Ah} and Kim, {Young Seok} and Kim, {In Hee} and Lee, {Byung Seok} and Lee, {Youn Jae} and Chung, {Woo Jin} and Jeong, {Sook Hyang}",
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Real-life effectiveness and safety of the daclatasvir/asunaprevir combination therapy for genotype 1b chronic hepatitis C patients : An emphasis on the pretreatment NS5A resistance-associated substitution test. / Jang, Eun Sun; Kim, Kyung Ah; Kim, Young Seok; Kim, In Hee; Lee, Byung Seok; Lee, Youn Jae; Chung, Woo Jin; Jeong, Sook Hyang.

In: Journal of Medical Virology, Vol. 91, No. 12, 01.12.2019, p. 2158-2165.

Research output: Contribution to journalArticle

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AU - Jang, Eun Sun

AU - Kim, Kyung Ah

AU - Kim, Young Seok

AU - Kim, In Hee

AU - Lee, Byung Seok

AU - Lee, Youn Jae

AU - Chung, Woo Jin

AU - Jeong, Sook Hyang

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N2 - This study aimed to investigate the real-life effectiveness and safety of daclatasvir (DCV) and asunaprevir (ASV) combination therapy in Korean patients. We consecutively enrolled patients with genotype 1b hepatitis C virus (HCV) infection treated with at least one dose of DCV/ASV combination therapy in seven tertiary hospitals of South Korea. The sustained virologic response (SVR) rates and safety according to intention-to-treat (ITT) and per-protocol (PP) analyses were evaluated. Among the 526 enrolled patients, 91% showed negative (87%) or “undetermined” (4%) resistance-associated substitution (RAS); 9% did not undergo RAS testing. The SVR rates for ITT and PP were 89.3% and 95.0% in treatment-naive patients and 93.2% and 95.6% in treatment-experienced patients, respectively. In PP analysis, negative RAS was associated with higher SVR (96.3%) than with “undetermined RAS” (85.7%) or “not tested for RAS” (84.4%). Adverse events were reported in 185 (35.4%) patients, and events leading to discontinuation were observed in 4.3% of the study population. Forty-two (8.0%) patients developed transaminase elevation (≥2 × upper normal limit), resulting in treatment discontinuation in six (1.1%) patients. DCV/ASV combination therapy showed acceptable efficacy in genotype 1b compensated HCV-infected patients with negative pretreatment RAS. Although most adverse events were tolerable to continue antiviral treatment, adequate monitoring for transaminase elevation is warranted.

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