Prospective Study
Copyright ©The Author(s) 2015. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Apr 21, 2015; 21(15): 4696-4706
Published online Apr 21, 2015. doi: 10.3748/wjg.v21.i15.4696
Direct-acting antiviral-based triple therapy on alpha-fetoprotein level in chronic hepatitis C patients
Koji Takayama, Norihiro Furusyo, Eiichi Ogawa, Hiroaki Ikezaki, Motohiro Shimizu, Masayuki Murata, Jun Hayashi
Koji Takayama, Norihiro Furusyo, Eiichi Ogawa, Hiroaki Ikezaki, Motohiro Shimizu, Masayuki Murata, Department of General Internal Medicine, Kyushu University Hospital, Fukuoka 812-8582, Japan
Koji Takayama, Norihiro Furusyo, Eiichi Ogawa, Hiroaki Ikezaki, Department of Environmental Medicine and Infectious Disease, Kyushu University, Fukuoka 812-8582, Japan
Jun Hayashi, Kyushu General Internal Medicine Center, Hara-Doi Hospital, Fukuoka 813-8588, Japan
Author contributions: Takayama K and Furusyo N conceived of and designed the study; Takayama K, Furusyo N, Ogawa E, Ikezaki H, Shimizu M and Murata M acquired the data; Takayama K and Furusyo N analyzed and interpreted the data; and Takayama K, Furusyo N, Ogawa E and Hayashi J drafted and revised the paper, and are responsible for the intellectual content.
Ethics approval: The study was reviewed and approved by the ethics committee of Kyushu University Hospital.
Clinical trial registration: The study was registered as a clinical trial on the University Hospital Medical Information Network (ID 000013784).
Informed consent: Written informed consent was obtained from each participant prior to the examination.
Conflict-of-interest: Norihiro Furusyo has received an investigator initiated study research grant from Janssen Pharmaceutical KK. He has also received research funding from Mitsubishi Tanabe Pharma Co., MSD KK, Chugai Co., Daiichi Sankyo Co., and Bristol-Myers KK. The remaining authors have no conflicts of interest.
Data sharing: Technical appendix, statistical code, and dataset are available from the corresponding author at (furusyo@gim.med.kyushu-u.ac.jp). 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: Norihiro Furusyo, MD, PhD, Department of General Internal Medicine, Kyushu University Hospital, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan. furusyo@gim.med.kyushu-u.ac.jp
Telephone: +81-92-6425909 Fax: +81-92-6425210
Received: August 28, 2014
Peer-review started: August 31, 2014
First decision: September 27, 2014
Revised: December 9, 2014
Accepted: January 21, 2015
Article in press: January 21, 2015
Published online: April 21, 2015
Processing time: 234 Days and 16.8 Hours
Abstract

AIM: To investigate the impact of telaprevir-based triple therapy on the serum alpha-fetoprotein (AFP) level of chronic hepatitis C patients.

METHODS: A total of 210 patients with chronic hepatitis C genotype 1 of high viral load (baseline serum hepatitis C virus RNA > 5.0 log10 IU/mL) were divided into two groups by type of treatment: triple therapy with telaprevir, pegylated-interferon-α (PEG-IFNα), and ribavirin (RBV) for 24 wk (n = 88), or dual therapy with PEG-IFNα and RBV for 48 wk (n = 122). The relationship between virological response and the change in the serum AFP level from baseline to 24 wk after the end of treatment was examined.

RESULTS: No significant difference in mean baseline AFP level was found between the triple and dual therapy groups (8.8 ng/mL vs 7.8 ng/mL). Triple therapy produced significant declines in the AFP level in sustained virological response (SVR) and non-SVR patients (7.8 ng/mL at baseline to 3.5 ng/mL at 24 wk after the end of treatment, P < 0.001 and 14.3 ng/mL to 9.5 ng/mL, P = 0.004, respectively). In contrast, dual therapy resulted in a significant decline in AFP level only in SVR patients (4.7 ng/mL to 2.8 ng/mL, P < 0.001), but not in non-SVR patients (10.2 ng/mL to 10.1 ng/mL). Among patients with a high-baseline AFP level (≥ 10 ng/mL), the decline in the AFP level was significantly higher in the triple therapy than in the dual therapy group (15.9 ng/mL vs 1.6 ng/mL, P = 0.037).

CONCLUSION: Regardless of virological response, telaprevir-based triple therapy reduced the serum AFP level.

Keywords: Chronic hepatitis C; Direct-acting antiviral agents; Hepatocellular carcinoma; Serum alpha-fetoprotein; Telaprevir

Core tip: Patients with hepatocellular carcinoma often have elevated serum alpha-fetoprotein concentrations, for which a high level is a risk factor for developing hepatocellular carcinoma in chronic hepatitis C patients. A recently introduced direct-acting antiviral agent, telaprevir, has been included in triple therapy regimens using a protease inhibitor with conventional pegylated-interferon-α and ribavirin, and has significantly improved the sustained virological response rate, up to 80% for patients with hepatitis C virus genotype 1. This study shows that regardless of virological response, telaprevir-based triple therapy more effectively reduces the serum alpha-fetoprotein level than dual therapy with pegylated-interferon-α and ribavirin.