Observational Study
Copyright ©The Author(s) 2017. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Apr 7, 2017; 23(13): 2396-2403
Published online Apr 7, 2017. doi: 10.3748/wjg.v23.i13.2396
Safety and efficacy of tenofovir in chronic hepatitis B-related decompensated cirrhosis
Soon Kyu Lee, Myeong Jun Song, Seok Hyun Kim, Byung Seok Lee, Tae Hee Lee, Young Woo Kang, Suk Bae Kim, Il Han Song, Hee Bok Chae, Soon Young Ko, Jae Dong Lee
Soon Kyu Lee, Myeong Jun Song, Division of Hepatology, Department of Internal Medicine, Daejeon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Daejeon 34943, South Korea
Seok Hyun Kim, Byung Seok Lee, Department of Internal Medicine, Chungnam University Hospital, Daejeon 35015, South Korea
Tae Hee Lee, Young Woo Kang, Department of Internal Medicine, Konyang University Hospital, Daejeon 35365, South Korea
Suk Bae Kim, Il Han Song, Department of Internal Medicine, Dankook University Hospital, Cheonan 31116, South Korea
Hee Bok Chae, Department of Internal Medicine, ChungBuk University Hospital, Cheongju 28644, South Korea
Soon Young Ko, Jae Dong Lee, Department of Internal Medicine, Konkuk University Chungju Hospital, Chungju 27376, South Korea
Author contributions: Lee SK wrote the paper; Song MJ, Kim SH, Lee BS, Lee TH, Kang YW, Kim SB, Song IH, Chae HB, Ko SY and Lee JD collected the data; Song MJ designed the study and analyzed the data.
Supported by the Catholic Medical Center Research Foundation program in 2014, No. 5-2014-B0001-00176.
Institutional review board statement: Ethics approval was provided by the institutional Ethics Review Board, The Catholic University of Korea (DC15RIMI0008).
Informed consent statement: All study participants provided informed written consent about medical data collection prior to study enrollment.
Conflict-of-interest statement: The authors declare no conflicts of interest.
Data sharing statement: The original anonymous dataset is available on request from the corresponding author at mjsong95@gmail.com.
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: Myeong Jun Song, MD, PhD, Division of Hepatology, Department of Internal Medicine, Daejeon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Daeheung-ro 64, Jung-gu, Daejeon 34943, South Korea. mjsong95@gmail.com
Telephone: +82-42-2209291
Received: January 4, 2017
Peer-review started: January 7, 2017
First decision: February 9, 2017
Revised: February 20, 2017
Accepted: March 15, 2017
Article in press: March 15, 2017
Published online: April 7, 2017
Processing time: 92 Days and 4.5 Hours
Abstract
AIM

To evaluate the safety and efficacy of tenofovir disoproxil fumarate (TDF) as a first-line therapy in decompensated liver disease.

METHODS

We enrolled 174 chronic hepatitis B-related liver cirrhosis patients treated with 300 mg/d TDF at six Korean centers. Of the 174 cirrhosis patients, 57 were assigned to the decompensated cirrhosis group and 117 were assigned to the compensated cirrhosis group. We followed the patients for 12 mo and evaluated clinical outcomes, including biochemical, virological, and serological responses. We also evaluated changes in hepatic and renal function and compared the decompensated and compensated cirrhosis groups.

RESULTS

The 1-year complete virological response (CVR) and Hepatitis B e antigen (HBeAg) seroconversion were seen in 70.2% and 14.2% in the decompensated cirrhosis group, respectively. The rates of HBeAg seroconversion/loss and ALT normalization at month 12 were similar in both groups. TDF treatment was also effective for decreasing the level of hepatitis B virus (HBV) DNA in both groups, but CVR was higher in the compensated group (88.9% vs 70.2%, P = 0.005). Tenofovir treatment for 12 mo resulted in improved Child-Turcotte-Pugh (CTP) and model for end-stage liver disease (MELD) scores in decompensated group (P < 0.001). Of the 57 decompensated patients, 39 (68.4%) achieved CTP class A and 27 (49.1%) showed improvement in the CTP score of 2 points after 12 mo of TDF. The observed rate of confirmed 0.5 mg/dL increases in serum levels of creatinine in the decompensated and compensated cirrhosis group were 7.0% and 2.5%, respectively (P < 1.000).

CONCLUSION

TDF therapy in decompensated cirrhosis patients was effective for decreasing HBV DNA levels and improving hepatic function with relatively lower CVR than in compensated cirrhosis. Thus, physicians should carefully monitor not only renal function but also treatment responses when using TDF in decompensated cirrhosis patients.

Keywords: Tenofovir; Decompensated liver cirrhosis; Compensated liver cirrhosis; Virological response; Renal safety

Core tip: We evaluated the safety and efficacy of disoproxil fumarate (TDF) treatment in patients with treatment-naïve chronic hepatitis B related decompensated cirrhosis. TDF therapy for 12 mo in decompensated cirrhosis patients was effective for decreasing hepatitis B virus DNA levels and improving hepatic function with relatively lower complete virological response (CVR) than in compensated cirrhosis (70.2% vs 88.9%). The elevation of serum creatinine (> 0.5 mg/dL) in the decompensated cirrhosis relatively higher compared to compensated cirrhosis patients (7.0% vs 2.5%, respectively, P < 1.000). Therefore, TDF therapy is useful in decompensated cirrhosis and needed for close monitoring of CVR and renal function.