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
- Authors
- Jang, Eun Sun; Kim, Kyung-Ah; Kim, Young Seok; Kim, In Hee; Lee, Byung Seok; Lee, Youn Jae; Chung, Woo Jin; Jeong, Sook-Hyang
- Issue Date
- Dec-2019
- Publisher
- John Wiley & Sons Inc.
- Keywords
- anti-hepatitis C virus DAA; antisense drug resistance; antiviral agents; hepatitis C virus
- Citation
- Journal of Medical Virology, v.91, no.12, pp 2158 - 2165
- Pages
- 8
- Journal Title
- Journal of Medical Virology
- Volume
- 91
- Number
- 12
- Start Page
- 2158
- End Page
- 2165
- URI
- https://scholarworks.bwise.kr/sch/handle/2021.sw.sch/4072
- DOI
- 10.1002/jmv.25575
- ISSN
- 0146-6615
1096-9071
- 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 x 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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