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Real-world Effectiveness and Safety of Direct-acting Antiviral Agents in Patients with Chronic Hepatitis C Genotype 2 Infection: Korean Multicenter Study

BACKGROUND: The advancement of treatment with direct-acting antiviral (DAA) agents has improved the cure rate of hepatitis C virus (HCV) infection close to 100%. The aim of our study was to assess the real-world effectiveness and safety of DAA regimens for the treatment of patients with chronic HCV...

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Autores principales: Kang, Yeo Wool, Baek, Yang Hyun, Lee, Sung Wook, Park, Sung-Jae, Yoon, Jun Sik, Yoon, Ki Tae, Hong, Youngmi, Heo, Nae-Yun, Seo, Kwang Il, Lee, Sang Soo, Cho, Hyun Chin, Shin, Jung Woo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: The Korean Academy of Medical Sciences 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8167412/
https://www.ncbi.nlm.nih.gov/pubmed/34060258
http://dx.doi.org/10.3346/jkms.2021.36.e142
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author Kang, Yeo Wool
Baek, Yang Hyun
Lee, Sung Wook
Park, Sung-Jae
Yoon, Jun Sik
Yoon, Ki Tae
Hong, Youngmi
Heo, Nae-Yun
Seo, Kwang Il
Lee, Sang Soo
Cho, Hyun Chin
Shin, Jung Woo
author_facet Kang, Yeo Wool
Baek, Yang Hyun
Lee, Sung Wook
Park, Sung-Jae
Yoon, Jun Sik
Yoon, Ki Tae
Hong, Youngmi
Heo, Nae-Yun
Seo, Kwang Il
Lee, Sang Soo
Cho, Hyun Chin
Shin, Jung Woo
author_sort Kang, Yeo Wool
collection PubMed
description BACKGROUND: The advancement of treatment with direct-acting antiviral (DAA) agents has improved the cure rate of hepatitis C virus (HCV) infection close to 100%. The aim of our study was to assess the real-world effectiveness and safety of DAA regimens for the treatment of patients with chronic HCV genotype 2. METHODS: We retrospectively analyzed the clinical data of patients treated with sofosbuvir plus ribavirin (SOF + RBV) or glecaprevir/pibrentasvir (G/P) for chronic HCV genotype 2 infection at seven university hospitals in the Korean southeast region. RESULTS: SOF + RBV therapy produced an 89% and 98.3% sustained virologic response 12 week (SVR12) after treatment completion in the full analysis set and per-protocol set, respectively, and the corresponding values for G/P therapy were 89.5% and 99.2%, respectively. The difference between the treatments was probably because 6.2% (59/953) of patients in the SOF + RBV group did not complete the treatment and 9.8% (14/143) in the G/P group did not test HCV RNA after treatment completion. Adverse events (A/Es) were reported in 59.7% (569/953) and 25.9% (37/143) of the SOF + RBV and G/P groups, respectively. In the SOF + RBV group, 12 (1.26%) patients discontinued treatment owing to A/Es, whereas no patients discontinued treatment because of A/Es in the G/P group. CONCLUSION: In both treatment groups, SVR was high when treatment was completed. However, there was a high dropout rate in the SOF + RBV group, and the dropout analysis showed that these were patients with liver cirrhosis (LC; 43/285, 15.1%), especially those with decompensated LC (12/32, 37.5%). Therefore, an early initiation of antiviral therapy is recommended for a successful outcome before liver function declines. Furthermore, patients with decompensated LC who are considered candidates for SOF + RBV treatment should be carefully monitored to ensure that their treatment is completed, especially those with low hemoglobin and high alanine transaminase.
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spelling pubmed-81674122021-06-04 Real-world Effectiveness and Safety of Direct-acting Antiviral Agents in Patients with Chronic Hepatitis C Genotype 2 Infection: Korean Multicenter Study Kang, Yeo Wool Baek, Yang Hyun Lee, Sung Wook Park, Sung-Jae Yoon, Jun Sik Yoon, Ki Tae Hong, Youngmi Heo, Nae-Yun Seo, Kwang Il Lee, Sang Soo Cho, Hyun Chin Shin, Jung Woo J Korean Med Sci Original Article BACKGROUND: The advancement of treatment with direct-acting antiviral (DAA) agents has improved the cure rate of hepatitis C virus (HCV) infection close to 100%. The aim of our study was to assess the real-world effectiveness and safety of DAA regimens for the treatment of patients with chronic HCV genotype 2. METHODS: We retrospectively analyzed the clinical data of patients treated with sofosbuvir plus ribavirin (SOF + RBV) or glecaprevir/pibrentasvir (G/P) for chronic HCV genotype 2 infection at seven university hospitals in the Korean southeast region. RESULTS: SOF + RBV therapy produced an 89% and 98.3% sustained virologic response 12 week (SVR12) after treatment completion in the full analysis set and per-protocol set, respectively, and the corresponding values for G/P therapy were 89.5% and 99.2%, respectively. The difference between the treatments was probably because 6.2% (59/953) of patients in the SOF + RBV group did not complete the treatment and 9.8% (14/143) in the G/P group did not test HCV RNA after treatment completion. Adverse events (A/Es) were reported in 59.7% (569/953) and 25.9% (37/143) of the SOF + RBV and G/P groups, respectively. In the SOF + RBV group, 12 (1.26%) patients discontinued treatment owing to A/Es, whereas no patients discontinued treatment because of A/Es in the G/P group. CONCLUSION: In both treatment groups, SVR was high when treatment was completed. However, there was a high dropout rate in the SOF + RBV group, and the dropout analysis showed that these were patients with liver cirrhosis (LC; 43/285, 15.1%), especially those with decompensated LC (12/32, 37.5%). Therefore, an early initiation of antiviral therapy is recommended for a successful outcome before liver function declines. Furthermore, patients with decompensated LC who are considered candidates for SOF + RBV treatment should be carefully monitored to ensure that their treatment is completed, especially those with low hemoglobin and high alanine transaminase. The Korean Academy of Medical Sciences 2021-05-06 /pmc/articles/PMC8167412/ /pubmed/34060258 http://dx.doi.org/10.3346/jkms.2021.36.e142 Text en © 2021 The Korean Academy of Medical Sciences. https://creativecommons.org/licenses/by-nc/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (https://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Original Article
Kang, Yeo Wool
Baek, Yang Hyun
Lee, Sung Wook
Park, Sung-Jae
Yoon, Jun Sik
Yoon, Ki Tae
Hong, Youngmi
Heo, Nae-Yun
Seo, Kwang Il
Lee, Sang Soo
Cho, Hyun Chin
Shin, Jung Woo
Real-world Effectiveness and Safety of Direct-acting Antiviral Agents in Patients with Chronic Hepatitis C Genotype 2 Infection: Korean Multicenter Study
title Real-world Effectiveness and Safety of Direct-acting Antiviral Agents in Patients with Chronic Hepatitis C Genotype 2 Infection: Korean Multicenter Study
title_full Real-world Effectiveness and Safety of Direct-acting Antiviral Agents in Patients with Chronic Hepatitis C Genotype 2 Infection: Korean Multicenter Study
title_fullStr Real-world Effectiveness and Safety of Direct-acting Antiviral Agents in Patients with Chronic Hepatitis C Genotype 2 Infection: Korean Multicenter Study
title_full_unstemmed Real-world Effectiveness and Safety of Direct-acting Antiviral Agents in Patients with Chronic Hepatitis C Genotype 2 Infection: Korean Multicenter Study
title_short Real-world Effectiveness and Safety of Direct-acting Antiviral Agents in Patients with Chronic Hepatitis C Genotype 2 Infection: Korean Multicenter Study
title_sort real-world effectiveness and safety of direct-acting antiviral agents in patients with chronic hepatitis c genotype 2 infection: korean multicenter study
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8167412/
https://www.ncbi.nlm.nih.gov/pubmed/34060258
http://dx.doi.org/10.3346/jkms.2021.36.e142
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