Serum HBV RNA Value on Chronic Hepatitis B Virus Infection Manage

Serum HBV RNA Level Monitoring During Chronic Hepatitis B Virus Infection Especialy in Patients Undergoing Long-term Nucleos(t)Ide Analoguage Treatment

As an alternative biomarker of intrahepatic covalently closed circular DNA(cccDNA) transcriptional activity, hepatitis B virus(HBV)RNA may evolve during long-lasting virus-host interactionsduring chronic hepatitis B viral infection.The distribution pattern of serum HBV RNA levels in the natural course of chronic HBV infection remains unclear. Furthermore,serum HBV RNA was associated with response to NAs. So it may be another clinical surrogate marker for intrahepatic cccDNA level after long-term NAs treatment and be used to monitor NAs therapy. The aim of this study was to evaluate thelevels of HBV RNA during the natural courseof CHB and the role in distinguishingthe natural phases of HBV infection and to investigate whether serum HBV RNA level at the end of long-term NAs treatment had a similar or better predict effect on off-therapy relapse than serum HBsAg titer.

Study Overview

• Status: Completed
• Conditions: Chronic HBV Infection; Drug Withdrawal
• Intervention / Treatment: Diagnostic test: serum HBV RNA

• Study Type: Observational
• Enrollment (Actual): 454

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic Hepatitis B virus infection receiving or not receiving NAs treatment

Description

Inclusion Criteria:

• 18 to 70 years old,
• no gender restriction,
• serum HBsAg positive than 6 months,
• can understand and sign informed consent,
• good compliance.

Exclusion Criteria:

• coinfected with other hepatotropic virus such as hepatitis C virus,hepatitis D -virus,hepatitis E and hepatitis A etc;
• coinfected with HIV,
• markers such as ceruloplasmin, anti-nuclear antibodies and anti-mitochondrial antibodies for co-existent autoimmune and metabolic liver diseases were positive,
• with hepatocellular carcinoma(HCC)
• with uncontrollable extrehepatic disease,
• received glucocorticoid or other immune inhibitor therapy,
• pregnancy.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
treatment-naïve; treatment-naïve patients with chronic HBV infection	Diagnostic test: serum HBV RNA; serum HBV RNA level was determined by using HBV-SAT kit at different time point
NAs treated CHB patients; CHB patients undergoing long-term NAs treatment	Diagnostic test: serum HBV RNA; serum HBV RNA level was determined by using HBV-SAT kit at different time point

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum HBV RNA value in treatment naive patients with chronic HBV infection were tested by using HBV SAT	serum HBV RNA level in patients with chronic HBV infection during different natural history stage were were compared. The relationship between serum HBV RNA and other viral markers,such as HBV DNA,HBeAg and HBsAg, were determined.	serum HBV RNA level were measured 24hs after the enrollment
End of treatment serum HBV RNA levels predict the 24-month off-therapy viral rebound	End of treatment serum HBV RNA in patients after long-term nucleos(t)ide analog therapy were tested and the predictive effect of EOT HBV RNA value on 24-month off-therapy viral rebound were determined.	Change in serum HBV DNA levels from stopping baseline to 24 month after drug cessation was determined

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum HBV RNA in patients receiving long-term NAs therapy were tested at different time point	serum HBV RNA change pattern along long-term NAs therapy wad determined and the relationship between HBV RNA and HBV DNA or HBsAg during NAs therapy were also determined	48 hrs after enrollment the serun HBV RNA level were tested
Number of patients with evaluate HBV DNA relapse(> 20,000 IU/mL) through 96 weeks off-therapy	the cumulative viral relapse rates at the 1st and 2nd year off-therapy were calculated	viral rebound rates were calculated from stopping baseline to 24 month after drug cessation

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Investigators: Principal Investigator: Xuesong Liang, Dr, Changhai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): May 1, 2020

Study Registration Dates

• First Submitted: April 1, 2019
• First Submitted That Met QC Criteria: April 8, 2019
• First Posted (Actual): April 9, 2019

Study Record Updates

• Last Update Posted (Actual): February 2, 2021
• Last Update Submitted That Met QC Criteria: January 30, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: HBsAg; HBV RNA; cccDNA; Nucleos(t)ide analogue; virological relapse
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Digestive System Diseases; Pathologic Processes; Substance-Related Disorders; Blood-Borne Infections; Disease Attributes; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis, Chronic; Hepatitis; Infections; Communicable Diseases; Hepatitis B; Virus Diseases; Hepatitis B, Chronic; Substance Withdrawal Syndrome; Herpesviridae Infections
• Other Study ID Numbers: HBV RNA2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No