Korean J Hepatobiliary Pancreat Surg.  2016 Feb;20(1):8-11. 10.14701/kjhbps.2016.20.1.8.

High-dose tenofovir is not effective in suppressing hepatitis B virus replication in patients with hepatocellular carcinoma progression: a preliminary result

• Hwang S
• Song GW
• Jung DH
• Yoon YI
• Yoo HJ
• Tak E

• KMID: 2243025
• DOI: http://doi.org/10.14701/kjhbps.2016.20.1.8

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+/-4.7 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

MeSH Terms

Carcinoma, Hepatocellular*
DNA
Follow-Up Studies
Hepatitis B virus*
Hepatitis B*
Hepatitis*
Humans
Male
Prospective Studies
Recurrence
Sleep Initiation and Maintenance Disorders
Tablets
Tenofovir
DNA
Tablets

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