Protocol: Prospective observational study aiming for micro-elimination of hepatitis C virus in Nagawa town: The Nagawa Project.

<h4>Background</h4>The World Health Organization has set a goal of hepatitis C virus (HCV) elimination by the year 2030. However, no regions in Japan have succeeded in eradicating HCV. Micro-elimination is an approach to attain hepatitis C eradication in which national eradication goals...

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Autores principales: Hiroyuki Kobayashi, Satoru Joshita, Yuki Akahane, Katsuhiko Matsuzaki, Hiromi Yamada, Daiki Aomura, Nao Joshita, Hajime Midorikawa, Kazuhiro Suyama, Masao Ota, Shun-Ichi Wakabayashi, Yuki Yamashita, Ayumi Sugiura, Tomoo Yamazaki, Hiromichi Misawa, Takeji Umemura
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Publicado: Public Library of Science (PLoS) 2021
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spelling oai:doaj.org-article:6dabe51c0eab4594940525b85f8f89332021-12-02T20:19:26ZProtocol: Prospective observational study aiming for micro-elimination of hepatitis C virus in Nagawa town: The Nagawa Project.1932-620310.1371/journal.pone.0256711https://doaj.org/article/6dabe51c0eab4594940525b85f8f89332021-01-01T00:00:00Zhttps://doi.org/10.1371/journal.pone.0256711https://doaj.org/toc/1932-6203<h4>Background</h4>The World Health Organization has set a goal of hepatitis C virus (HCV) elimination by the year 2030. However, no regions in Japan have succeeded in eradicating HCV. Micro-elimination is an approach to attain hepatitis C eradication in which national eradication goals are applied to specific populations so that viral treatment and control efforts can move forward quickly and efficiently. In order to eradicate HCV from Japan, this study aims to achieve HCV micro-elimination in the town of Nagawa.<h4>Methods and design</h4>The Nagawa Project is an ongoing, prospective, multiple-institution, observational study running from April 1, 2021, to March 31, 2024. All residents of Nagawa town, excluding those under 20 years of age, not consenting to the study, or unable to undergo health check-ups due to nursing care needs, will be included. If found to be HCV antibody-positive, the participant will be recommended to see a doctor in consideration of MAC-2 binding protein glycosylation isomer values. Then, the participant will undergo serum HCV RNA measurement with the real-time polymerase chain reaction by an attending physician. If the participant is HCV RNA-positive, he or she will be referred to a hepatologist for further evaluation. In the case of a definitive diagnosis of chronic hepatitis C, direct acting antiviral treatment will be initiated. Through this process, HCV will be systematically micro-eliminated from the region.<h4>Discussion</h4>The Nagawa Project will reveal the prevalence of chronic HCV in addition to the HCV eradication rate in Nagawa town towards achieving HCV micro-elimination.<h4>Trial registration</h4>This study is performed by Shinshu University School of Medicine and was registered as UMIN 000044114 on May 6, 2021.Hiroyuki KobayashiSatoru JoshitaYuki AkahaneKatsuhiko MatsuzakiHiromi YamadaDaiki AomuraNao JoshitaHajime MidorikawaKazuhiro SuyamaMasao OtaShun-Ichi WakabayashiYuki YamashitaAyumi SugiuraTomoo YamazakiHiromichi MisawaTakeji UmemuraPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 16, Iss 8, p e0256711 (2021)
institution DOAJ
collection DOAJ
language EN
topic Medicine
R
Science
Q
spellingShingle Medicine
R
Science
Q
Hiroyuki Kobayashi
Satoru Joshita
Yuki Akahane
Katsuhiko Matsuzaki
Hiromi Yamada
Daiki Aomura
Nao Joshita
Hajime Midorikawa
Kazuhiro Suyama
Masao Ota
Shun-Ichi Wakabayashi
Yuki Yamashita
Ayumi Sugiura
Tomoo Yamazaki
Hiromichi Misawa
Takeji Umemura
Protocol: Prospective observational study aiming for micro-elimination of hepatitis C virus in Nagawa town: The Nagawa Project.
description <h4>Background</h4>The World Health Organization has set a goal of hepatitis C virus (HCV) elimination by the year 2030. However, no regions in Japan have succeeded in eradicating HCV. Micro-elimination is an approach to attain hepatitis C eradication in which national eradication goals are applied to specific populations so that viral treatment and control efforts can move forward quickly and efficiently. In order to eradicate HCV from Japan, this study aims to achieve HCV micro-elimination in the town of Nagawa.<h4>Methods and design</h4>The Nagawa Project is an ongoing, prospective, multiple-institution, observational study running from April 1, 2021, to March 31, 2024. All residents of Nagawa town, excluding those under 20 years of age, not consenting to the study, or unable to undergo health check-ups due to nursing care needs, will be included. If found to be HCV antibody-positive, the participant will be recommended to see a doctor in consideration of MAC-2 binding protein glycosylation isomer values. Then, the participant will undergo serum HCV RNA measurement with the real-time polymerase chain reaction by an attending physician. If the participant is HCV RNA-positive, he or she will be referred to a hepatologist for further evaluation. In the case of a definitive diagnosis of chronic hepatitis C, direct acting antiviral treatment will be initiated. Through this process, HCV will be systematically micro-eliminated from the region.<h4>Discussion</h4>The Nagawa Project will reveal the prevalence of chronic HCV in addition to the HCV eradication rate in Nagawa town towards achieving HCV micro-elimination.<h4>Trial registration</h4>This study is performed by Shinshu University School of Medicine and was registered as UMIN 000044114 on May 6, 2021.
format article
author Hiroyuki Kobayashi
Satoru Joshita
Yuki Akahane
Katsuhiko Matsuzaki
Hiromi Yamada
Daiki Aomura
Nao Joshita
Hajime Midorikawa
Kazuhiro Suyama
Masao Ota
Shun-Ichi Wakabayashi
Yuki Yamashita
Ayumi Sugiura
Tomoo Yamazaki
Hiromichi Misawa
Takeji Umemura
author_facet Hiroyuki Kobayashi
Satoru Joshita
Yuki Akahane
Katsuhiko Matsuzaki
Hiromi Yamada
Daiki Aomura
Nao Joshita
Hajime Midorikawa
Kazuhiro Suyama
Masao Ota
Shun-Ichi Wakabayashi
Yuki Yamashita
Ayumi Sugiura
Tomoo Yamazaki
Hiromichi Misawa
Takeji Umemura
author_sort Hiroyuki Kobayashi
title Protocol: Prospective observational study aiming for micro-elimination of hepatitis C virus in Nagawa town: The Nagawa Project.
title_short Protocol: Prospective observational study aiming for micro-elimination of hepatitis C virus in Nagawa town: The Nagawa Project.
title_full Protocol: Prospective observational study aiming for micro-elimination of hepatitis C virus in Nagawa town: The Nagawa Project.
title_fullStr Protocol: Prospective observational study aiming for micro-elimination of hepatitis C virus in Nagawa town: The Nagawa Project.
title_full_unstemmed Protocol: Prospective observational study aiming for micro-elimination of hepatitis C virus in Nagawa town: The Nagawa Project.
title_sort protocol: prospective observational study aiming for micro-elimination of hepatitis c virus in nagawa town: the nagawa project.
publisher Public Library of Science (PLoS)
publishDate 2021
url https://doaj.org/article/6dabe51c0eab4594940525b85f8f8933
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