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©The Author(s) 2017. Published by Baishideng Publishing Group Inc. All rights reserved.
Efficacy and safety of sofosbuvir and ledipasvir in Japanese patients aged 75 years or over with hepatitis C genotype 1
Yoshinori Ozono, Kenji Nagata, Satoru Hasuike, Hisayoshi Iwakiri, Kenichi Nakamura, Mai Tsuchimochi, Yuri Yamada, Yuka Takaishi, Mitsue Sueta, Tadashi Miike, Yoshihiro Tahara, Shojiro Yamamoto, Kotaro Shide, Tomonori Hidaka, Yoko Kubuki, Kazunori Kusumoto, Toshimasa Ochiai, Junya Kato, Naoto Komada, Shuichi Hirono, Kazuo Kuroki, Masafumi Shigehira, Kazuya Shimoda
Yoshinori Ozono, Satoru Hasuike, Hisayoshi Iwakiri, Kenichi Nakamura, Yuri Yamada, Yuka Takaishi, Mitsue Sueta, Tadashi Miike, Yoshihiro Tahara, Shojiro Yamamoto, Kotaro Shide, Tomonori Hidaka, Yoko Kubuki, Kazuya Shimoda, Department of Gastoroenterology and Hematology, Faculty of Medicine, University of Miyazaki, Miyazaki 889-1601, Japan
Kenji Nagata, Mai Tsuchimochi, Kazuya Shimoda, Department of Liver Disease, University of Miyazaki Hospital, Miyazaki 889-1601, Japan
Kazunori Kusumoto, Toshimasa Ochiai, Department of Internal Medicine, Koga General Hospital, Miyazaki 880-0041, Japan
Junya Kato, Naoto Komada, Department of Internal Medicine, National Hospital Organization Miyakonojo Medical Center, Miyazaki 885-0014, Japan
Shuichi Hirono, Department of Internal Medicine, Hirono Naika Clinic, Miyazaki 880-0925, Japan
Kazuo Kuroki, Department of Internal Medicine, Kushima Municipal Hospital, Miyazaki 888-0001, Japan
Masafumi Shigehira, Department of Internal Medicine, Shigehira Clinic, Miyazaki 885-0005, Japan
Author contributions: Ozono Y and Nagata K contributed to the study conception and design; Hasuike S, Iwakiri H, Nakamura K, Tsuchimochi M, Yamada Y, Takaishi Y, Sueta M, Miike T, Tahara Y, Yamamoto S, Kusumoto K, Ochiai T, Kato J, Komada N, Hirono S, Kuroki K and Shigehira M contributed to data acquisition; Shide K, Hidaka T, Kubuki Y and Shimoda K contributed to drafting the manuscript and revisions; all authors gave final approval of the version to be published.
Institutional review board statement: This study was approved by the Research Ethics Committee of the University of Miyazaki.
Informed consent statement: Informed consent was obtained from all the patients.
Conflict-of-interest statement: There are no conflict-of-interests involved in the article.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Dr. Kenji Nagata, MD, PhD, Department of Liver Disease, University of Miyazaki Hospital, 5200 Kihara, Kiyotake, Miyazaki 889-1601, Japan. nagatakj@med.miyazaki-u.ac.jp
Telephone: +81-985-859121 Fax: +81-985-855194
Received: August 25, 2017
Peer-review started: August 26, 2017
First decision: September 20, 2017
Revised: October 10, 2017
Accepted: November 3, 2017
Article in press: November 3, 2017
Published online: December 28, 2017
ARTICLE HIGHLIGHTS
Research background
The majority of Japanese patients with hepatitis C are elderly, however, elderly patients (≥ 75 years) treated with interferon (IFN)-based therapies have poor sustained virological response (SVR) rates and high discontinuation rates due to AEs. As a result, it is critical that new anti-viral therapies be developed for elderly patients. The combination of sofosbuvir (SOF) and ledipasvir (LDV) was approved in Japan, and though this regimen has demonstrated high efficacy with an improved safety profile and shorter therapy duration than IFN-based therapies, there are few real-world studies of Japanese patients aged ≥ 75 years.
Research motivation
Evaluating the efficacy and safety of SOF and LDV in elderly patients with hepatitis C genotype 1 will help clinicians assess whether they can treat these patients similarly to younger patients in the real-world.
Research objectives
To evaluate the efficacy and safety of SOF and LDV in Japanese elderly patients with hepatitis C genotype 1.
Research methods
Demographic, clinical, virological, and AE-related data obtained during and after SOF/LDV therapy were retrospectively collected from medical records.
Research results
The SVR rates at 12 wk after treatment were 99.2%, 99.4%, and 98.7% in the overall population and in patients aged < 75 and ≥ 75 years, respectively. Common AEs occurred in fewer than 10% of patients, and their incidence was not significantly different between the younger and elderly groups.
Research conclusions
The present study demonstrated that patients aged ≥ 75 years had a similar virological response and tolerance to SOF/LDV therapy compared with patients aged < 75 years in a real-world cohort. Therefore, SOF/LDV therapy might be effective and safe in elderly patients.
Research perspectives
Further prospective studies with large sample sizes are necessary.
