Prospective Study
Copyright ©The Author(s) 2017. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Aug 28, 2017; 23(32): 5969-5976
Published online Aug 28, 2017. doi: 10.3748/wjg.v23.i32.5969
Efficacy and safety of sofosbuvir and daclatasvir in treatment of kidney transplantation recipients with hepatitis C virus infection
Yan Xue, Li-Xin Zhang, Lei Wang, Tao Li, Yun-Dong Qu, Feng Liu
Yan Xue, Li-Xin Zhang, Lei Wang, Tao Li, Yun-Dong Qu, Feng Liu, Department of Infectious Diseases and Hepatology, the Second Hospital of Shandong University, Jinan 250033, Shandong Province, China
Author contributions: Xue Y and Zhang LX contributed equally to this work; Wang L, Li T, Qu YD and Liu F conceived the study; Wang L, Xue Y and Zhang LX designed the research; Wang L, Xue Y and Zhang LX collected the data; Xue Y, Zhang LX and Qu YD analyzed the data; Xue Y wrote the article; Xue Y, Zhang LX and Li T revised the manuscript for final submission; Wang L participated in the study supervision.
Supported by the Project of Science and Technology Development Plan of Jinan City, No. 201506004; and Youth Fund of the Second Hospital of Shandong University, No. Y2014010014.
Institutional review board statement: The study protocol was approved by the Ethical Committee of the Second Hospital of Shandong University.
Informed consent statement: Written informed consent was obtained from all patients.
Conflict-of-interest statement: All authors have no conflicts of interest.
Data sharing statement: There are no additional data available in relation to this manuscript.
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: Lei Wang, PhD, MD, Professor, Department of Infectious Diseases and Hepatology, the Second Hospital of Shandong University, 247 Beiyuan Road, Jinan 250033, Shandong Province, China. wlcrb@sdu.edu.cn
Telephone: +86-5318-5875122
Received: May 31, 2017
Peer-review started: May 31, 2017
First decision: June 22, 2017
Revised: July 3, 2017
Accepted: July 12, 2017
Article in press: July 12, 2017
Published online: August 28, 2017
Processing time: 89 Days and 5.3 Hours
Abstract
AIM

To assess the efficacy and safety of sofosbuvir and daclatasvir regimens for kidney transplantation (KT) patients with hepatitis C virus (HCV) infection.

METHODS

This study enrolled a prospective cohort of consecutive Chinese KT patients with HCV infection. They were given sofosbuvir combined with daclatasvir, with or without ribavirin. They were monitored regularly during and after the treatment.

RESULTS

Six patients were recruited in our prospective study cohort. All patients were male and naive to direct-acting antiviral treatment. The treatment duration was 12 wk. Most patients (4/6) were infected with HCV genotype 1b. HCV RNA was undetectable at week 4 after treatment and at the end of treatment in all patients. Sustained virological response rate at 12 wk was 100% (6/6). Two patients had to accept a half dose of sofosbuvir due to serum creatinine elevation during treatment. Kidney function in the remaining patients was stable. No serious adverse events (AEs) were observed. No patient discontinued antiviral therapy due to side effects.

CONCLUSION

Sofosbuvir and daclatasvir for treatment of KT recipients with HCV infection are highly efficient and safe. Patients tolerated the medications well, and no serious AEs were observed. Larger prospective cohort studies are needed to validate these results.

Keywords: Hepatitis C virus; Sofosbuvir; Daclatasvir; Kidney transplantation; Direct-acting antivirals

Core tip: This is a prospective study to assess the efficacy and safety of sofosbuvir and daclatasvir regimens for kidney transplantation (KT) patients with hepatitis C virus (HCV) infection. This study enrolled a prospective cohort of consecutive Chinese KT patients with HCV infection. The recipients were given sofosbuvir combined with daclatasvir with or without ribavirin. Sofosbuvir and daclatasvir treatments are highly efficient and safe. Patients tolerated the regimens and no serious adverse events were observed. Larger prospective cohort studies are needed to validate these results.