Effects of Antiviral Therapy on HBV Reactivation (HBV-DNA(-))

June 8, 2017 updated by: Jian-Hong Zhong, Guangxi Medical University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Entecavir therapy
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
Patients in the antiviral group received entecavir begin in the first 3 days before surgery for at lest 1 month.
NO_INTERVENTION: No antiviral therapy
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?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangxi Medical University

Investigators

  • Study Director: Le-Qun Li, MD, Cancer Hospital of Guangxi Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

July 8, 2016

First Submitted That Met QC Criteria

July 11, 2016

First Posted (ESTIMATE)

July 12, 2016

Study Record Updates

Last Update Posted (ACTUAL)

June 12, 2017

Last Update Submitted That Met QC Criteria

June 8, 2017

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HBV-DNA(-)/HCC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Study Data/Documents

  1. Clinical Study Report
    Information comments: Oncotarget. 2017 Feb 28;8(9):15047-15056. doi: 10.18632/oncotarget.14789.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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