Hepatitis B Reactivation During Treatment With Direct-Acting Antiviral Agents for Chronic Hepatitis C Infection
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03248622|
Recruitment Status : Enrolling by invitation
First Posted : August 14, 2017
Last Update Posted : January 18, 2019
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.
To study HBV reactivation in people with CHC and resolved HBV infection who are being treated with interferon-free DAA-based therapy.
Data were collected from adults 18 and older in studies that were done in 2012 and 2016.
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|
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 Type :||Observational|
|Actual Enrollment :||79 participants|
|Official Title:||Hepatitis B Reactivation During Treatment With Direct-Acting Antiviral Agents for Chronic Hepatitis C Infection|
|Estimated Study Start Date :||January 23, 2019|
|Estimated Primary Completion Date :||June 30, 2019|
|Estimated Study Completion Date :||June 30, 2019|
HCV positive Cohort
HCV positive Cohort
- The rate of HBV reactivation among patient with resolved HBV infection undergoing Interferon-free DAA-based therapy for HCV infection. [ Time Frame: 6 months of Rx ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03248622
|United States, Maryland|
|National Institute of Diabetes and Digestive and Kidney Disorders (NIDDK)|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Marc G Ghany, M.D.||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|