Hepatitis B Reactivation During Treatment With Direct-Acting Antiviral Agents for Chronic Hepatitis C Infection

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)

Overall Status

Completed

CT.gov ID

NCT03248622

Collaborator

(none)

Enrollment

Location

23.8

Actual Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Background:

Treatment of some diseases can suppress the immune system. This can cause other conditions to reactivate. Recent cases have shown that hepatitis B virus (HBV) reactivates in people who had already recovered from it during treatment for chronic hepatitis C (CHC). Their treatment was direct-acting antiviral (DAA) agents. Researchers want to see how common this reactivation is. They want to learn what the effects are. They will study data that have already been collected.

Objectives:

To study HBV reactivation in people with CHC and resolved HBV infection who are being treated with interferon-free DAA-based therapy.

Eligibility:

Data were collected from adults 18 and older in studies that were done in 2012 and 2016.

Design:

Researchers will screen the records from the previous studies. They will identify participants who had HBV infection before they got DAA-based treatment.

Researchers will take data from those records. This will include data on:

Age, sex, race, and ethnicity
Treatment and disease status
Lab results

Researchers will test stored samples. They will test samples that were taken before, during, and after treatment. They will check if HBV was reactivated. They will also check if other clinical outcomes occurred.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis B

Detailed Description

Reactivation of hepatitis B is well known to occur with immunosuppression as in the setting of high dose immunosuppressive therapy, cancer chemotherapy and bone marrow or stem cell transplantation. It is usually subclinical but at times can manifest as an acute hepatitis, hepatic decompensation and death. Often times this leads to interruption of cancer chemotherapy.

Recently, several case reports and case series have revealed evidence of hepatitis B virus (HBV) reactivation in previously recovered persons being treated for chronic hepatitis C (CHC) with direct-acting antiviral (DAA) agents. Given the severity of some cases, the U.S. Food and Drug Administration (FDA) has issued a Black Box warning regarding the risk of HBV reactivation to HCV DAA labeling to screen all hepatitis C patients for HBV before initiation of therapy and to monitor those with previous HBV infection for signs of reactivation while on treatment. However, since the FDA warning, retrospective experiences on clinical trials have failed to reveal evidence of viral reactivation. Further, the frequency of HBV reactivation and its risk factors and monitoring frequency in HCV patients receiving Interferon-free DAA therapy are yet unknown. Hence, we aim to conduct a multicenter retrospective analysis to investigate these issues.

Study Design

Study Type:

Observational

Actual Enrollment :

79 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

Hepatitis B Reactivation During Treatment With Direct-Acting Antiviral Agents for Chronic Hepatitis C Infection

Actual Study Start Date :

Jun 3, 2017

Actual Primary Completion Date :

May 28, 2019

Actual Study Completion Date :

May 28, 2019

Arms and Interventions

Arm	Intervention/Treatment
Anti-HBc positive Anti-HBc positive
HCV positive Cohort HCV positive Cohort

Outcome Measures

Primary Outcome Measures

The rate of HBV reactivation among patient with resolved HBV infection undergoing Interferon-free DAA-based therapy for HCV infection. [From initiation of treatment to 24 weeks post-treatment]
Detection of HBV DNA or HBsAg and elevated ALT level

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

INCLUSION CRITERIA:
Adult patients (greater than or equal to 18 years) with CHC who underwent treatment with an Interferon-free DAA-based therapy.
Evidence of resolved HBV infection prior to starting interferon-free DAAbased therapy (HBsAg-negative with positive anti-HBc +/- positive anti-HBs)