Effects of Antiviral Therapy on HBV Reactivation

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02829359

Acronym

HBV-DNA(-)

Enrollment

200

Registered

2016-07-12

Start date

2012-07-31

Completion date

2015-12-31

Last updated

2017-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cancer

Brief summary

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.

Interventions

DRUGEntecavir therapy

Patients in the antiviral group received entecavir begin in the first 3 days before surgery for at lest 1 month.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Rate of HBV reactivation	1 month after surgery
HBV reactivation on the recovery of liver function	1 month after surgery

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026