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©The Author(s) 2017. Published by Baishideng Publishing Group Inc. All rights reserved.
Efficacy and safety of dual therapy with daclatasvir and asunaprevir in elderly patients
Kazuo Tarao, Katsuaki Tanaka, Akito Nozaki, Akira Sato, Toshiya Ishii, Hirokazu Komatsu, Takaaki Ikeda, Tatsuji Komatsu, Shozo Matsushima, Kenji Oshige
Kazuo Tarao, Tarao’s Gastroenterological Clinic, Yokohama 241-0821, Japan
Katsuaki Tanaka, Akito Nozaki, Gastroenterological Center, Medical Center, Yokohama City University, Yokohama 232-0024, Japan
Akira Sato, Toshiya Ishii, Division of Gastroenterology, Department of Internal Medicine, St. Marianna University, Yokohama City Seibu Hospital, Yokohama 241-0811, Japan
Hirokazu Komatsu, Department of Gastroenterology, Yokohama Municipal Citizen’s Hospital, Yokohama 240-8555, Japan
Takaaki Ikeda, Department of Gastroenterology, Yokosuka General Hospital Uwamachi, Yokosuka 238-8567, Japan
Tatsuji Komatsu, Shozo Matsushima, Department of Clinical Research, National Hospital Organization, Yokohama Medical Center, Yokohama 245-8575, Japan
Kenji Oshige, Yokohama National University, Center for Health Service Sciences, Yokohama 240-8501, Japan
Author contributions: Tarao K designed the research; Tanaka K, Nozaki A, Ishii T, Komatsu H, Ikeda T, Komatsu T and Matsushima S followed up the HCV patients in field practice; Oshige K analyzed the data; Tarao K wrote the paper; all the descriptions of the paper were distributed to all authors and confirmed.
Institutional review board statement: The study was approved by institutional review boards in each hospital and conducted in compliance with the Declaration of Helsinki.
Informed consent statement: Written informed consent was obtained from all patients.
Conflict-of-interest statement: Tanaka K has received research funding from Bristol-Myers Squibb and AbbVie; Nozaki A has received research funding from Gilead Sciences; Tarao K, Sato A, Ishii T, Komatsu H, Ikeda T, Komatsu T, Matsushima S and Oshige K declare that have no conflict of interest.
Data sharing statement: No additional data are available.
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: Kazuo Tarao, MD, Tarao’s Gastroenterological Clinic, Taiyo-Building, 2-58-6, Futamatagawa, Asahi-ku, Yokohama 241-0821, Japan.
nrg18449@nifty.com
Telephone: +81-45-3606501 Fax: +81-45-3606502
Received: October 18, 2016
Peer-review started: October 23, 2016
First decision: December 20, 2016
Revised: January 19, 2017
Accepted: February 8, 2017
Article in press: February 13, 2017
Published online: April 18, 2017
Processing time: 177 Days and 3.5 Hours
AIM
To survey the efficacy and safety of dual therapy with daclatasvir and asunaprevir in the elderly hepatitis C virus (HCV) patients multicentricity.
METHODS
Interferon-ineligible/intolerant patients and non-responders to previous pegylated-interferon/ribavirin therapy with chronic HCV genotype 1b infection were enrolled. Child B, C cirrhotic patients were excluded. Patients received oral direct acting antiviral treatment consisting of 60 mg daclatasvir once daily plus 200 mg asunaprevir twice daily for 24 wk. We divided the patients into two groups of 56 elderly patients (≥ 75 years-old) and 141 non-elderly patients (< 75 years old) and compared the efficacy and safety.
RESULTS
Ninety-one point one percent of elderly patients and 90.1% of non-elderly patients achieved sustained virological response at 24 wk (SVR24). In the former, 1.8% experienced viral breakthrough, as compared with 3.5% in the latter (not significant). Adverse events occurred in 55.4% of the former and 56.0% of the latter. In the former, 7 cases (12.5%) were discontinued due to adverse events, and in the latter 9 cases were discontinued (6.4%, not significant).
CONCLUSION
Dual therapy with daclatasvir and asunaprevir achieved the same high rates of SVR24 in HCV elderly patients without more adverse events than in the non-elderly patients.
Core tip: Recently, it was demonstrated that dual oral therapy with daclatasvir and asunaprevir without pegylated-interferon/ribavirin was well tolerated and achieved high sustained virological response rates in Japanese patients with chronic hepatitis C virus genotype Ιb infection, including patients with liver cirrhosis (Child A stage). However, the efficacy and side effects of these drugs was previously studied in non-elderly patients (less than 70 years of age). Those in elderly patients, who are supposed to have higher incidence of hepatocellular carcinoma, have not been studied. We demonstrated that efficacy and side effects in elderly patients were nearly the same as in non-elderly patients.
