Hepatitis B Reactivation During Treatment With Direct-Acting Antiviral Agents for Chronic Hepatitis C Infection
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Hepatitis, Hepatitis, Hepatitis, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/6/2019 |
| Start Date: | April 10, 2019 |
| End Date: | June 30, 2019 |
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.
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.
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.
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.
- 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)
EXCLUSION CRITERIA:
- Treatment with Nucleos(t)ide Analogues (NA) active against HBV prior to initiation of
interferon-free DAA therapy
We found this trial at
1
site
31 Center Drive
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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