Observational Study
Copyright ©The Author(s) 2017. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Jun 14, 2017; 23(22): 4072-4079
Published online Jun 14, 2017. doi: 10.3748/wjg.v23.i22.4072
Efficacy and safety of combined directly acting antivirals for treatment of Chinese chronic hepatitis C patients in a real-world setting
Jian-Hong Chen, Zheng Zeng, Xia-Xia Zhang, Yu Zhang, Ren-Wen Zhang, Shuai Wang, Chi-Hong Wu, Min Yu, Dan Liu, Hong-Li Xi, Yi-Xing Zhou, Yao-Yu An, Xiao-Yuan Xu
Jian-Hong Chen, Zheng Zeng, Xia-Xia Zhang, Yu Zhang, Ren-Wen Zhang, Chi-Hong Wu, Min Yu, Dan Liu, Hong-Li Xi, Yi-Xing Zhou, Yao-Yu An, Xiao-Yuan Xu, Department of Infectious Diseases, Peking University First Hospital, Xicheng District, Beijing 100034, China
Shuai Wang, Department of Hepatology, General Hospital of Beijing Military Region, Beijing 100700, China
Author contributions: Xu XY designed the research; Chen JH performed the research; Chen JH, Zeng Z, Zhang XX, Zhang Y, Zhang RW, Wang S, Wu CH, Yu M, Liu D, Xi HL, Zhou YX and An YY contributed to data collection; Chen JH analysed the data and wrote the paper.
Supported by National Natural Science Foundation of China, No. 81373056; Beijing Municipal Committee of Science and Technology, No. D161100002716003; National Major Project for Infectious Diseases Control, No. 2012ZX10002003-004-003.
Institutional review board statement: The study was reviewed and approved by Peking University People Hospital Institutional Review Board.
Informed consent statement: All study participants provided informed written consent prior to study enrollment.
Conflict-of-interest statement: The authors declare that no conflict of interest exists.
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: Xiao-Yuan Xu, Professor, Department of Infectious Diseases, Peking University First Hospital, Xicheng District, Beijing 100034, China. xiaoyuanxu6@163.com
Telephone: +86-10-83575787 Fax: +86-10-83575787
Received: February 9, 2017
Peer-review started: February 11, 2017
First decision: March 3, 2017
Revised: March 16, 2017
Accepted: April 12, 2017
Article in press: April 12, 2017
Published online: June 14, 2017
Processing time: 124 Days and 14.7 Hours
Abstract
AIM

To assess the efficacy and safety of combined directly acting antivirals (DAAs) for the treatment of Chinese chronic hepatitis C (CHC) patients in a real-world setting.

METHODS

Hospitalized CHC patients who were treated with DAAs at Peking University First Hospital between January 2015 and December 2016 were enrolled. Samples and clinical data were collected at 0 wk, 2 wk, 4 wk, 8 wk, 12 wk, or 24 wk during DAAs treatment and at 4 wk, 12 wk, and 24 wk after the end of treatment.

RESULTS

Fifty-four patients who underwent DAAs treatment were included in our study, of whom 83.3% (45/54) achieved rapid virological response at 2 wk after treatment initiation (RVR 2) and 94.4% (51/54) achieved sustained virological response at 24 wk after the end of treatment (SVR 24). Serum creatinine and uric acid levels at the end of treatment were significantly increased compared with baseline levels (83.6 ± 17.9 vs 88.8 ± 19.4, P01 < 0.001; 320.8 ± 76.3 vs 354.5 ± 87.6, P01 < 0.001), and no significant improvements were observed at 24w after the end of treatment (83.6 ± 17.9 vs 86.8 ± 19.1, P02 = 0.039; 320.8 ± 76.3 vs 345.9 ± 89.4, P02 = 0.001). The total frequency of adverse events (AEs) during treatment was 33.3% (18/54), with major AEs being fatigue (16.7%), headache (7.4%), anorexia (7.4%), and insomnia (5.6%).

CONCLUSION

Though based in a small cohort of patients, the abnormal changes in renal function indices and relative high frequency of AEs during combined DAAs treatment should be taken as a note of caution.

Keywords: Chronic hepatitis C; Directly acting antivirals; Efficacy; Safety; China

Core tip: Treatment of hepatitis C virus infection has reached a new era with the approval of directly acting antivirals (DAAs), while there had been limited data on the use of DAAs treatment in a real-world setting in China. We explored the changes of hepatorenal function indices before and after DAAs treatment and found that serum creatinine and uric acid levels at the end of treatment were significantly increased compared with baseline levels, and no significant improvements were observed at 24 wk after the end of treatment. This study may serve as a reminder to clinicians to implement close renal function monitoring in patients receiving combined DAAs treatment.