HBV Reactivation: A Safety Concern With DAA Use in HBV/HCV Coinfection

HealthDay News — 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 in the Annals of Internal Medicine.

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

The researchers found that 2 cases resulted in death and 1 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, 9, 7, and 3 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 7 cases and possibly in 7 others despite provider knowledge of baseline HBV.

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“Patients with a history of HBV require clinical monitoring while receiving DAA therapy,” the researchers 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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Bersoff-Matcha SJ, Cao K, Jason M, Ajao A, Jones SC, Meyer T, Brinker A. Hepatitis B Virus Reactivation associated with direct-acting antiviral therapy for chronic hepatitis C virus: a review of cases reported to the US Food and Drug Administration adverse event reporting system [published online April 25, 2017]. Ann Intern Med. doi: 10.7326/M17-0377