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HBV Reactivation Is Concern With DAA Tx in HBV-HCV Coinfection

TUESDAY, April 25, 2017 -- Hepatitis B virus (HBV) reactivation (HBV-R) is a safety concern for patients with HBV and hepatitis C virus (HCV) coinfection receiving direct-acting antiviral agents (DAAs), according to a study published online April 24 in the Annals of Internal Medicine.

Susan J. Bersoff-Matcha, M.D., from the U.S. Food and Drug Administration in Silver Spring, Maryland, and colleagues reviewed data from the U.S. Food and Drug Administration Adverse Event Reporting System for 29 patients with HBV-R receiving HCV DAAs.

The researchers found that two cases resulted in death and one resulted in liver transplantation. Heterogeneity was seen for patients in whom HBV-R developed in terms of HCV genotype, DAAs received, and baseline HBV characteristics. At baseline, nine, seven, and three patients had a detectable HBV viral load, had positive results on hepatitis B surface antigen (HBsAg) testing and an undetectable HBV viral load, and had negative results on HBsAg testing and an undetectable HBV viral load, respectively. Data points were not reported or data were uninterpretable for the remaining 10 patients. HBV-R diagnosis and treatment were delayed in seven cases and possibly in seven others despite provider knowledge of baseline HBV.

"Patients with a history of HBV require clinical monitoring while receiving DAA therapy," the authors write. "Studies would help determine the risk factors for HBV-R, define monitoring frequency, and identify patients who may benefit from HBV prophylaxis and treatment."

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Posted: April 2017