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Antiviral Therapy Reduces Hepatocellular Carcinoma Recurrence in Patients With Low HBV-DNA Levels

A Randomized Controlled Trial

Huang, Gang, MD*; Li, Peng-peng, MD*; Lau, Wan Yee, MD, FRCS, FACS, FRACS(Hon)*,†; Pan, Ze-ya, MD*; Zhao, Ling-hao, MD*; Wang, Zhen-guang, MD*; Wang, Meng-chao, MD*; Zhou, Wei-ping, MD*

doi: 10.1097/SLA.0000000000002727
RANDOMIZED CONTROLLED TRIAL

Background: Despite antiviral treatment has been shown to reduce hepatocellular carcinoma (HCC) recurrence after curative treatment for hepatitis B virus (HBV)-related HCC in patients with high preoperative HBV-DNA levels, it is still unclear whether antiviral therapy is useful in reducing recurrence in patients with low preoperative HBV-DNA levels.

Methods: In this randomized controlled trial, 200 patients who underwent curative resection for HCC with low baseline HBV-DNA levels were randomly assigned to receive preemptive antiviral therapy or not. The primary endpoints were recurrence-free survival. This study was censored on March 31, 2015 when all surviving patients had a minimum follow-up of 60 months. The analysis was done on an intention-to-treat basis.

Results: The baseline clinical, laboratory, and tumor characteristics of the 2 groups were comparable. The 1-, 3-, and 5-year recurrence-free survival rates for the antiviral group and the control group were 85.9%, 55.2%, and 52.0% and 80.6%, 40.9%, and 32.3%, respectively. The corresponding overall survival rates for the 2 groups were 94.0%, 75.7%, and 64.1% and 90.0%, 62.4%, and 43.7%, respectively. The recurrence-free survival and overall survival for the antiviral group were significantly better than the control group (P = 0.016, P = 0.004, respectively). After adjusting for confounding prognostic factors in a Cox model, the relative risks of recurrence and death for antiviral treatment were 0.601 [95% confidence interval (CI), 0.409–0.884; P = 0.010] and 0.509 (95% CI, 0.333–0.778; P = 0.002), respectively. Antiviral therapy was an independent protective factor of late tumor recurrence (hazard ratio [HR] = 0.316, 95% CI 0.157–0.637; P = 0.001) but not of early tumor recurrence (HR = 0.782, 95% CI, 0.493–1.240; P = 0.296).

Conclusions: In patients with low preoperative HBV-DNA levels, antiviral therapy significantly reduced HCC recurrence after R0 hepatic resection.

*Eastern Hepatobiliary Surgery Hospital, National Innovation Alliance for Hepatitis and Liver Cancer, Shanghai, China

Faculty of Medicine, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong SAR, People's Republic of China.

Reprints: Wei-ping Zhou, MD, Gang Huang, MD, Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital, National Innovation Alliance for Hepatitis and Liver Cancer, No. 225 Changhai Rd., Shanghai 200438, China. E-mail: ehphwp@126.com; squaror@163.com.

G.H. and P.L. contributed equally to this work.

This study was funded by the Project of Science and Technology Commission of Shanghai Municipality: 14411967800; National Science Foundation of China: 81572941; National Key Basic Research Program of China: 2014CB542102; and Creative Research Groups Grant: 81221061.

The authors declare no conflicts of interest.

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