Copyright
©The Author(s) 2020. Published by Baishideng Publishing Group Inc. All rights reserved.
Sofosbuvir plus ribavirin is tolerable and effective even in elderly patients 75-years-old and over
Hideyuki Tamai, Naoki Shingaki, Yoshiyuki Ida, Ryo Shimizu, Shuya Maeshima, Junpei Okamura, Akira Kawashima, Taisei Nakao, Takeshi Hara, Hiroyoshi Matsutani, Izumi Nishikawa, Katsuhiko Higashi
Hideyuki Tamai, Naoki Shingaki, Department of Hepatology, Wakayama Rosai Hospital, Wakayama 6408505, Japan
Yoshiyuki Ida, Ryo Shimizu, Shuya Maeshima, Second Department of Internal Medicine, Wakayama Medical University, Wakayama 6418509, Japan
Junpei Okamura, Akira Kawashima, Taisei Nakao, Department of Internal Medicine, Naga Municipal Hospital, Wakayama 6496414, Japan
Takeshi Hara, Department of Gastroenterology, Wakayama Rosai Hospital, Wakayama 6408505, Japan
Hiroyoshi Matsutani, Izumi Nishikawa, Katsuhiko Higashi, First Department of Internal Medicine, Hidaka General Hospital, Wakayama 6440002, Japan
Author contributions: Tamai H drafted the manuscript, provided oversight of the study, and performed data analysis; Shingaki N, Ida Y, Shimizu R, Maeshima S, Okamura J, Kawashima A, Nakao T, Hara T, Matsutani H, Nisikawa I, and Higashi K participated in the design and were involved with data collection; all authors read and approved the final manuscript.
Institutional review board statement: All study protocols were approved by the ethics committees of the participating hospitals.
Informed consent statement: Written informed consent was obtained from all patients included in this study.
Conflict-of-interest statement: The authors of this manuscript have no conflicts of interest to disclose.
Data sharing statement: There is no additional data available.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (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/
Corresponding author: Hideyuki Tamai, MD, PhD, Director, Department of Hepatology, Wakayama Rosai Hospital, 93-1 Kinomoto, Wakayama 6408505, Japan. hdy-tamai@wakayamah.johas.go.jp
Received: April 10, 2020
Peer-review started: April 10, 2020
First decision: April 26, 2020
Revised: July 12, 2020
Accepted: July 26, 2020
Article in press: July 26, 2020
Published online: September 27, 2020
BACKGROUND
Although clinical use of sofosbuvir plus ribavirin has been approved for patients infected with genotype 2 hepatitis C virus, patients ≥ 75-years-old have not been included in previous clinical trials.
AIM
To evaluate the real-world safety and efficacy of sofosbuvir plus ribavirin for elderly patients (≥ 75-years-old) compared to nonelderly patients, we conducted a post-marketing prospective cohort study.
METHODS
We treated 265 patients with genotype 2 hepatitis C virus using standard approved doses of sofosbuvir (400 mg/d) plus ribavirin adjusted by body weight, administered orally for 12 wk.
RESULTS
Sustained virological response rates for the overall cohort, patients < 65-years-old, ≥ 65-years-old but < 75-years-old, and ≥ 75-years-old were 97% (258/265), 98% (93/95), 97% (84/87), and 98% (81/83), respectively (P = 0.842). Logistic regression analyses identified history of hepatocellular carcinoma treatment and alpha-fetoprotein as factors significantly associated with sustained virological response. Alpha-fetoprotein was the only independent factor identified. Sustained virological response rate was significantly lower for patients with hepatocellular carcinoma treatment (91%) than for patients without history of hepatocellular carcinoma treatment (98%, P = 0.004). One patient (0.4%) discontinued treatment due to drug-induced pneumonia. Dose reduction or interruption of ribavirin was required for 12.1% (32/265) of patients because of anemia, including 7.7% (14/182) of patients < 75-years-old and 21.7% (18/83) of patients ≥ 75-years-old (P = 0.002).
CONCLUSION
Although ribavirin dose reduction or interruption was required with advanced age, sofosbuvir plus ribavirin appears tolerable and highly effective even in patients ≥ 75-years-old.
Core Tip: This was a multicenter post-marketing prospective cohort study of sofosbuvir plus ribavirin therapy for patients with genotype 2 hepatitis C virus in a real-world clinical setting. Combination therapy using sofosbuvir plus ribavirin was tolerable and highly effective even in elderly patients ≥ 75-years-old.
