Effects of Antiviral Therapy on HBV Reactivation

Study Overview
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Brief Summary
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Hepatitis B virus (HBV) reactivation happens after liver resection for HBV-related hepatocellular carcinoma (HCC) patients, particularly for those with positive serum HBV-DNA . The incidence rate and risk factors of HBV reactivation after hepatectomy for serum HBV-DNA negative HBV-related HCC are unclear.

Detailed Description
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Hepatitis B virus (HBV) reactivation happens after liver resection for HBV-related hepatocellular carcinoma (HCC) patients, particularly for those with positive serum HBV-DNA . The incidence rate and risk factors of HBV reactivation after hepatectomy for serum HBV-DNA negative HBV-related HCC are unclear.From July 2012 to December 2015, 174 consecutive patients with serum HBV-DNA negative HBV-related HCC underwent resection were prospectively enrolled in the studied. There are 66 patients received preoperative antiviral therapy (antiviral group) and 108 patients did not receive any antiviral therapy (non-antiviral group). The incidence of HBV reactivation, risk factors of liver function were analyzed in perioperative period. HBV reactivation developed in 30 patients (27.8%) in the non- antiviral group and 2 patients (3.0%) in the antiviral group, respectively (P < 0.001). Multivariate analysis revealed that minor hepatectomy (HR, 4.695; 95% CI, 1.257-17.537, P = 0.021) and without antiviral therapy (HR, 8.164; 95% CI, 1.831-36.397, p =0.006) were risk factors attributed to HBV reactivation. Patients in antiviral group and non-antiviral group or reactivation group and without reactivation group have similar ALT, TBil, ALB, and PT in 7 days after resection. However, patients in antiviral group have significantly better ALT and ALB on day 30th after resection than those in control group. Moreover, similar phenomenon were observed when comparing those with or without HBV reactivation. Resection could lead to HBV reactivation during the perioperative period for serum HBV DNA negative HBV-related HCC, especially in patients who did not receive any antiviral therapy. Anti-HBV therapy can reduce the risk of reactivation, thus improving liver function after hepatectomy.

Official Title
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Effects of Antiviral Therapy on HBV Reactivation and Liver Function After Hepatectomy for HBV-DNA Negative HBV-related Hepatocellular Carcinoma

Conditions
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Liver Cancer

Intervention / Treatment
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* Drug: Entecavir therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: underwent initial hepatectomy; preoperative serum HBsAg positive serum HBV DNA negative serum ALT in normal range Child-Pugh A liver function HCC was confirmed by histopathology patients in the treated group received Entecavir (ENT) while patients in the control group did not receive any antiviral therapy. Exclusion Criteria: underwent preoperative TACE or other anti-tumor treatments underwent preoperative antiviral treatment for nearly a year with autoimmune disease, other organ malignant tumor, or other severe disease.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Entecavir therapy<br>Patients who received entecavir (zhengda Tianqing Co., Ltd, Lianyungang, Jiangsu Province, China; 0.5 mg/d) were submitted to antiviral group. Patients in the antiviral group received entecavir begin in the first 3 days before surgery for at lest 1 month. No immunological therapy in perioperative period will be submitted to any included patients. | Drug: Entecavir therapy<br>* Patients in the antiviral group received entecavir begin in the first 3 days before surgery for at lest 1 month.<br>|
| No Intervention: No antiviral therapy<br>Patients who did not receive any antiviral therapies were submitted as non-antiviral group. Patients in the non-antiviral group who underwent HBV reactivation will receive entecavir therapy. No immunological therapy in perioperative period will be submitted to any included patients. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of HBV reactivation |  | 1 month after surgery | 
| HBV reactivation on the recovery of liver function |  | 1 month after surgery |