No Consistent Pattern of HBV Reactivation With Direct-acting Antivirals for HCV
NEW YORK (Reuters Health) - The largest case review to date of hepatitis B virus (HBV) reactivation associated with direct-acting antiviral (DAA) therapy for chronic hepatitis C virus (HCV) infection found no consistent pattern in terms of which patients are likely to develop this adverse event.
There was also no consistency with regard to the DAA regimen most likely to lead to HBV reactivation, suggesting a potential class-effect with DAA agents, researchers from the U.S. Food and Drug Administration (FDA) report in a paper online today in Annals of Internal Medicine.
HBV reactivation associated with DAA therapy is a “newly identified safety concern in patients previously infected with HBV. Patients with a history of HBV infection require clinical monitoring while receiving DAA therapy,” write Dr. Susan Bersoff-Matcha and colleagues.
They reviewed 29 cases of HBV reactivation in patients receiving DAAs reported to the FDAs adverse event reporting system between 2013 and 2016.
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Annals of Internal Medicine
NEW YORK (Reuters Health) - The largest case review to date of hepatitis B virus (HBV) reactivation associated with direct-acting antiviral (DAA) therapy for chronic hepatitis C virus (HCV) infection found no consistent pattern in terms of which patients are likely to develop this adverse event.
There was also no consistency with regard to the DAA regimen most likely to lead to HBV reactivation, suggesting a potential class-effect with DAA agents, researchers from the U.S. Food and Drug Administration (FDA) report in a paper online today in Annals of Internal Medicine.
HBV reactivation associated with DAA therapy is a “newly identified safety concern in patients previously infected with HBV. Patients with a history of HBV infection require clinical monitoring while receiving DAA therapy,” write Dr. Susan Bersoff-Matcha and colleagues.
They reviewed 29 cases of HBV reactivation in patients receiving DAAs reported to the FDAs adverse event reporting system between 2013 and 2016.
Continue reading.....
Full Text Article
Annals of Internal Medicine
Hepatitis B Virus Reactivation Associated With Direct-Acting Antiviral Therapy for Chronic Hepatitis C Virus
Susan J. Bersoff-Matcha, MD; Kelly Cao, PharmD; Mihaela Jason, PharmD; Adebola Ajao, PhD; S. Christopher Jones, PharmD, MS, MPH; Tamra Meyer, PhD, MPH; and Allen Brinker, MD, MS
Susan J. Bersoff-Matcha, MD; Kelly Cao, PharmD; Mihaela Jason, PharmD; Adebola Ajao, PhD; S. Christopher Jones, PharmD, MS, MPH; Tamra Meyer, PhD, MPH; and Allen Brinker, MD, MS
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Abstract
Background:
Direct-acting antiviral agents (DAAs) are used increasingly to treat hepatitis C virus (HCV) infection. Reports were published recently on hepatitis B virus (HBV) reactivation (HBV-R) in patients with HBV–HCV co-infection. Hepatitis B virus reactivation, defined as an abrupt increase in HBV replication in patients with inactive or resolved HBV infection, may result in clinically significant hepatitis.
Objective: To assess whether HBV-R is a safety concern in patients receiving HCV DAAs.
Design: Descriptive case series.
Setting: U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS).
Patients: 29 patients with HBV-R receiving HCV DAAs.
Results:
The FDA identified 29 unique reports of HBV-R in patients receiving DAAs from 22 November 2013 to 15 October 2016. Two cases resulted in death and 1 case in liver transplantation. Patients in whom HBV-R developed were heterogeneous regarding HCV genotype, DAAs received, and baseline HBV chacteristics. At baseline, 9 patients had a detectable HBV viral load, 7 had positive results on hepatitis B surface antigen (HBsAg) testing and had an undetectable HBV viral load, and 3 had negative results on HBsAg testing and had an undetectable HBV viral load. For the remaining 10 patients, data points were not reported or the data were uninterpretable. Despite provider knowledge of baseline HBV, HBV-R diagnosis and treatment were delayed in 7 cases and possibly 7 others.
The FDA identified 29 unique reports of HBV-R in patients receiving DAAs from 22 November 2013 to 15 October 2016. Two cases resulted in death and 1 case in liver transplantation. Patients in whom HBV-R developed were heterogeneous regarding HCV genotype, DAAs received, and baseline HBV chacteristics. At baseline, 9 patients had a detectable HBV viral load, 7 had positive results on hepatitis B surface antigen (HBsAg) testing and had an undetectable HBV viral load, and 3 had negative results on HBsAg testing and had an undetectable HBV viral load. For the remaining 10 patients, data points were not reported or the data were uninterpretable. Despite provider knowledge of baseline HBV, HBV-R diagnosis and treatment were delayed in 7 cases and possibly 7 others.
Limitations:
The quality of information varied among reports. Because reporting is voluntary, HBV-R associated with DAAs likely is underreported.
The quality of information varied among reports. Because reporting is voluntary, HBV-R associated with DAAs likely is underreported.
Conclusion:
Hepatitis B virus reactivation is a newly identified safety concern in patients with HBV–HCV co-infection treated with DAAs. Patients with a history of HBV require clinical monitoring while receiving DAA therapy. Studies would help determine the risk factors for HBV-R, define monitoring frequency, and identify patients who may benefit from HBV prophylaxis and treatment. DAAs remain a safe and highly effective treatment for the management of HCV infection.
Hepatitis B virus reactivation is a newly identified safety concern in patients with HBV–HCV co-infection treated with DAAs. Patients with a history of HBV require clinical monitoring while receiving DAA therapy. Studies would help determine the risk factors for HBV-R, define monitoring frequency, and identify patients who may benefit from HBV prophylaxis and treatment. DAAs remain a safe and highly effective treatment for the management of HCV infection.
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In The Media
Direct-acting antiviral therapy for hepatitis C virus associated with hepatitis B virus reactivation in co-infected patients
April 25, 2017 | Deepti Shroff and Evelyn Nguyen
In The Media
Direct-acting antiviral therapy for hepatitis C virus associated with hepatitis B virus reactivation in co-infected patients
April 25, 2017 | Deepti Shroff and Evelyn Nguyen
HBV-R is a manageable adverse event, and DAAs continue to be a safe and very effective treatment for infection with HCV.
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