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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
Processing time: 123 Days and 21.4 Hours
AIM
To evaluate the efficacy and safety of a regimen containing sofosbuvir (SOF) and ledipasvir (LDV) in Japanese patients aged ≥ 75 years with hepatitis C genotype 1.
METHODS
This multicenter, retrospective study consisted of 246 Japanese patients with HCV genotype 1 at nine centers in Miyazaki prefecture in Japan. Demographic, clinical, virological, and adverse effects (AE)-related data obtained during and after SOF/LDV therapy were collected from medical records. These patients were divided into two groups, younger (aged < 75 years) and elderly (aged ≥ 75 years). Virological data and AEs were analyzed by age group.
RESULTS
The sustained virological response (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 during therapy were headache, pruritus, constipation, and insomnia. These occurred in fewer than 10% of patients, and their incidence was not significantly different between the younger and elderly groups. Two patients discontinued treatment, one due to a skin eruption and the other due to cerebral bleeding.
CONCLUSION
Compared with younger patients, elderly patients had a similar virological response and tolerance to SOF/LDV therapy.
Core tip: Most Japanese patients with hepatitis C are elderly, and those aged ≥ 75 years account for more than 50%. However there are few reports regarding sofosbuvir (SOF) and ledipasvir (LDV) therapy in patients aged ≥ 75 years in the real-world. 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 the real-world cohorts. Therefore, SOF/LDV therapy might be effective and safe in elderly patients.
