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KMID : 0870420160200010008
Korean Journal of Hepato-Biliary-Pancreatic Surgery
2016 Volume.20 No. 1 p.8 ~ p.11
High-dose tenofovir is not effective in suppressing hepatitis B virusreplication in patients with hepatocellular carcinoma progression: a preliminary result
Hwang Shin

Song Gi-Won
Jung Dong-Hwan
Yoon Young-In
Yoo Hyun-Ju
Tak Eun-Young
Abstract
Backgrounds/Aims: Nucleos(t)ide analogues (NUCs) effectively suppress hepatitis B virus (HBV) replication, but hepatocellular carcinoma (HCC) recurrence often leads to HBV replication despite NUC therapy. The aim of this study was to determine whether high-dose tenofovir (TNF) therapy can suppresses HCC recurrence-associated HBV replication.
Methods: We performed a single-arm prospective study to assess the clinical feasibility of high-dose TNF (hdTNF). We recruited 10 patients during September 2015 and followed up for 3 months or early drop-out.

Results: All 10 patients had HCC of advanced stages due to HCC recurrence and gradual progression. The average age of patients was 51.2¡¾4.7 years and 9 were male. Three patients did not tolerate the increased TNF dosage and were dropped out early. The other 7 patients were relatively tolerable to the increased dosage of TNF 5 tablets per day. One patient had mild gastrointestinal symptoms and another patient complained of insomnia. Increased HBV replication and HCC progression was observed despite hdTNF for 4-8 weeks. All 7 patients showed tumor progression during the 3 month follow-up. In these patients, blood HBV DNA before hdTNF was 50-200 copies/ml; and 4-8 weeks after hdTNF, the HBV replication status was not improved with blood HBV DNA of 50-300 copies/ml. This clinical study was terminated early after these negative results were confirmed.

Conclusions: The results of this study indicated that high dose of TNF up to 5-fold the recommended dosage is not tolerated by a considerable proportion of patients and also ineffective in suppressing HCC progression-associated HBV replication.
KEYWORD
Nucleoside analogues, Entecavir, Covalently closed circular DNA, HBV X protein, Recurrence
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