Direct-acting antivirals in East Asian hepatitis C patients: real-world experience from the REAL-C Consortium

For the REAL-C Investigators

Research output: Contribution to journalArticle

Abstract

Background and aims: One-third of the global hepatitis C virus (HCV) burden is found in Asia. Real-world data from diverse East Asian cohorts remain limited. This study addressed the real-world status of direct-acting antiviral (DAA) therapy among patients from East Asia. Methods: Chronic hepatitis C (CHC) patients from clinical sites in Japan, Taiwan, South Korea, and Hong Kong were recruited in the REAL-C registry, an observational chart review registry. The primary outcome was sustained virologic response (SVR12, HCV RNA PCR < 25 IU/mL 12 week post-therapy). Results: A total of 6287 CHC patients were enrolled. Compared to other East Asian patients, patients from Japan were older (66.3 vs. 61.5 years, p < 0.0001), had lower body mass indices (22.9 kg/m2 vs. 24.6 kg/m2, p < 0.001), and were more likely to have non-liver malignancy history (12.2% vs. 5.0%, p < 0.001).The overall SVR12 rate was 96.4%, similar to patients both inside and outside Japan (96.6% vs. 96%, p = 0.21). The SVR12 rate ranged from 91.1 to 99.4% except treatment-experienced cirrhotic HCV genotype-1 patients who received daclatasvir/asunaprevir (85.9%) and the treatment-experienced cirrhotic HCV genotype-2 patients treated with sofosbuvir/ribavirin (87%). The overall rate of drug discontinuation was 1.9%, also similar across regions. On multivariate regression analyses, there was no significant association between geographic region and SVR outcomes. Conclusions: In this large multinational CHC cohort from the East Asia, oral DAAs were highly effective and well tolerated across the region. Policies should encourage treatment for all CHC patients with DAAs in Asia with its heavy burden of HCV.

Original languageEnglish
Pages (from-to)587-598
Number of pages12
JournalHepatology International
Volume13
Issue number5
DOIs
Publication statusPublished - Sep 1 2019

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Hepatitis C
Antiviral Agents
Hepacivirus
Chronic Hepatitis C
Japan
Far East
Registries
Genotype
Therapeutics
Republic of Korea
Ribavirin
Hong Kong
Taiwan
Body Mass Index
Multivariate Analysis
Regression Analysis
RNA
Polymerase Chain Reaction
Pharmaceutical Preparations

All Science Journal Classification (ASJC) codes

  • Hepatology

Cite this

Direct-acting antivirals in East Asian hepatitis C patients : real-world experience from the REAL-C Consortium. / For the REAL-C Investigators.

In: Hepatology International, Vol. 13, No. 5, 01.09.2019, p. 587-598.

Research output: Contribution to journalArticle

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abstract = "Background and aims: One-third of the global hepatitis C virus (HCV) burden is found in Asia. Real-world data from diverse East Asian cohorts remain limited. This study addressed the real-world status of direct-acting antiviral (DAA) therapy among patients from East Asia. Methods: Chronic hepatitis C (CHC) patients from clinical sites in Japan, Taiwan, South Korea, and Hong Kong were recruited in the REAL-C registry, an observational chart review registry. The primary outcome was sustained virologic response (SVR12, HCV RNA PCR < 25 IU/mL 12 week post-therapy). Results: A total of 6287 CHC patients were enrolled. Compared to other East Asian patients, patients from Japan were older (66.3 vs. 61.5 years, p < 0.0001), had lower body mass indices (22.9 kg/m2 vs. 24.6 kg/m2, p < 0.001), and were more likely to have non-liver malignancy history (12.2{\%} vs. 5.0{\%}, p < 0.001).The overall SVR12 rate was 96.4{\%}, similar to patients both inside and outside Japan (96.6{\%} vs. 96{\%}, p = 0.21). The SVR12 rate ranged from 91.1 to 99.4{\%} except treatment-experienced cirrhotic HCV genotype-1 patients who received daclatasvir/asunaprevir (85.9{\%}) and the treatment-experienced cirrhotic HCV genotype-2 patients treated with sofosbuvir/ribavirin (87{\%}). The overall rate of drug discontinuation was 1.9{\%}, also similar across regions. On multivariate regression analyses, there was no significant association between geographic region and SVR outcomes. Conclusions: In this large multinational CHC cohort from the East Asia, oral DAAs were highly effective and well tolerated across the region. Policies should encourage treatment for all CHC patients with DAAs in Asia with its heavy burden of HCV.",
author = "{For the REAL-C Investigators} and Huang, {Chung Feng} and Etsuko Iio and Jun, {Dae Won} and Eiichi Ogawa and Hidenori Toyoda and Hsu, {Yao Chun} and Hiroaki Haga and Shinji Iwane and Masaru Enomoto and Lee, {Dong Hyun} and Grace Wong and Liu, {Chen Hua} and Toshifumi Tada and Chuang, {Wan Long} and Ramsey Cheung and Jun Hayashi and Tseng, {Cheng Hao} and Satoshi Yasuda and Sally Tran and Leslie Kam and Linda Henry and Jeong, {Jae Yoon} and Hideyuki Nomura and Park, {Seung Ha} and Makoto Nakamuta and Huang, {Jee Fu} and Tai, {Chi Ming} and Lo, {Gin Ho} and Lee, {Mei Hsuan} and Yang, {Hwai I.} and Kao, {Jia Horng} and Akihiro Tamori and Yuichiro Eguchi and Yoshiyuki Ueno and Norihiro Furusyo and Yasuhito Tanaka and Yu, {Ming Lung} and Nguyen, {Mindie H.}",
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T1 - Direct-acting antivirals in East Asian hepatitis C patients

T2 - real-world experience from the REAL-C Consortium

AU - For the REAL-C Investigators

AU - Huang, Chung Feng

AU - Iio, Etsuko

AU - Jun, Dae Won

AU - Ogawa, Eiichi

AU - Toyoda, Hidenori

AU - Hsu, Yao Chun

AU - Haga, Hiroaki

AU - Iwane, Shinji

AU - Enomoto, Masaru

AU - Lee, Dong Hyun

AU - Wong, Grace

AU - Liu, Chen Hua

AU - Tada, Toshifumi

AU - Chuang, Wan Long

AU - Cheung, Ramsey

AU - Hayashi, Jun

AU - Tseng, Cheng Hao

AU - Yasuda, Satoshi

AU - Tran, Sally

AU - Kam, Leslie

AU - Henry, Linda

AU - Jeong, Jae Yoon

AU - Nomura, Hideyuki

AU - Park, Seung Ha

AU - Nakamuta, Makoto

AU - Huang, Jee Fu

AU - Tai, Chi Ming

AU - Lo, Gin Ho

AU - Lee, Mei Hsuan

AU - Yang, Hwai I.

AU - Kao, Jia Horng

AU - Tamori, Akihiro

AU - Eguchi, Yuichiro

AU - Ueno, Yoshiyuki

AU - Furusyo, Norihiro

AU - Tanaka, Yasuhito

AU - Yu, Ming Lung

AU - Nguyen, Mindie H.

PY - 2019/9/1

Y1 - 2019/9/1

N2 - Background and aims: One-third of the global hepatitis C virus (HCV) burden is found in Asia. Real-world data from diverse East Asian cohorts remain limited. This study addressed the real-world status of direct-acting antiviral (DAA) therapy among patients from East Asia. Methods: Chronic hepatitis C (CHC) patients from clinical sites in Japan, Taiwan, South Korea, and Hong Kong were recruited in the REAL-C registry, an observational chart review registry. The primary outcome was sustained virologic response (SVR12, HCV RNA PCR < 25 IU/mL 12 week post-therapy). Results: A total of 6287 CHC patients were enrolled. Compared to other East Asian patients, patients from Japan were older (66.3 vs. 61.5 years, p < 0.0001), had lower body mass indices (22.9 kg/m2 vs. 24.6 kg/m2, p < 0.001), and were more likely to have non-liver malignancy history (12.2% vs. 5.0%, p < 0.001).The overall SVR12 rate was 96.4%, similar to patients both inside and outside Japan (96.6% vs. 96%, p = 0.21). The SVR12 rate ranged from 91.1 to 99.4% except treatment-experienced cirrhotic HCV genotype-1 patients who received daclatasvir/asunaprevir (85.9%) and the treatment-experienced cirrhotic HCV genotype-2 patients treated with sofosbuvir/ribavirin (87%). The overall rate of drug discontinuation was 1.9%, also similar across regions. On multivariate regression analyses, there was no significant association between geographic region and SVR outcomes. Conclusions: In this large multinational CHC cohort from the East Asia, oral DAAs were highly effective and well tolerated across the region. Policies should encourage treatment for all CHC patients with DAAs in Asia with its heavy burden of HCV.

AB - Background and aims: One-third of the global hepatitis C virus (HCV) burden is found in Asia. Real-world data from diverse East Asian cohorts remain limited. This study addressed the real-world status of direct-acting antiviral (DAA) therapy among patients from East Asia. Methods: Chronic hepatitis C (CHC) patients from clinical sites in Japan, Taiwan, South Korea, and Hong Kong were recruited in the REAL-C registry, an observational chart review registry. The primary outcome was sustained virologic response (SVR12, HCV RNA PCR < 25 IU/mL 12 week post-therapy). Results: A total of 6287 CHC patients were enrolled. Compared to other East Asian patients, patients from Japan were older (66.3 vs. 61.5 years, p < 0.0001), had lower body mass indices (22.9 kg/m2 vs. 24.6 kg/m2, p < 0.001), and were more likely to have non-liver malignancy history (12.2% vs. 5.0%, p < 0.001).The overall SVR12 rate was 96.4%, similar to patients both inside and outside Japan (96.6% vs. 96%, p = 0.21). The SVR12 rate ranged from 91.1 to 99.4% except treatment-experienced cirrhotic HCV genotype-1 patients who received daclatasvir/asunaprevir (85.9%) and the treatment-experienced cirrhotic HCV genotype-2 patients treated with sofosbuvir/ribavirin (87%). The overall rate of drug discontinuation was 1.9%, also similar across regions. On multivariate regression analyses, there was no significant association between geographic region and SVR outcomes. Conclusions: In this large multinational CHC cohort from the East Asia, oral DAAs were highly effective and well tolerated across the region. Policies should encourage treatment for all CHC patients with DAAs in Asia with its heavy burden of HCV.

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U2 - 10.1007/s12072-019-09974-z

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