Patients with HCV/HBV may experience HBV-reactivation after DAA therapy

BOSTON — A small group of patients with hepatitis C virus and hepatitis B virus coinfection experienced spontaneous HBV reactivation after successful direct-acting antiviral therapy, according to findings presented at The Liver Meeting 2016.

Susan J. Bersoff-Matcha, MD, of the Office of Pharmacovigilance and Epidemiology at the FDA, and colleagues, aimed to assess the prevalence of spontaneous HBV reactivation in the DAA era. They investigated cases of this spontaneous reactivation in the FDA’s Adverse Event Reporting System between Nov. 22, 2013 and July 18, 2016 for evidence of HBV DNA increase or HBsAg seroconversion, according to the abstract.

Results indicated 24 unique reports of HBV reactivation were associated with DAA therapy. Of these cases, there were two fatalities and one incidence of liver transplantation. The researchers reported heterogeneity in terms of the HCV genotype, DAA regimen and baseline viral parameters of the HBV infection among patients who spontaneously reactivated. There were seven patients with detectable HBV viral load at baseline analysis. Four patients had a positive HBsAg and an undetectable viral load, while three patients had a negative HBsAg and undetectable HBV viral load. For the remainder of the case patients, these data were either unavailable or unable to be interpreted.

“DAAs are safe and effective drugs for the treatment of HCV,” Bersoff-Matcha told HCV Next in an interview. “All patients should be screened for evidence of current or prior hepatitis B viral infection before starting HCV treatment. Health care providers should monitor patients with evidence of current or prior HBV infection for HBV reactivation during treatment and post-treatment follow-up, and they should initiate appropriate patient management as clinically indicated.”

Even in cases where the provider was aware of the patient’s HBV viral status, five patients experienced a delay in diagnosis and treatment of HBV reactivation. A possible delay was reported in three other patients.

HBV reactivation is a newly identified safety concern in patients with HCV/HBV coinfection who are undergoing DAA therapy, the researchers concluded. Patients with a history of HBV who are being treated with these drugs should be monitored, and further study should elucidate risk factors and strategies for monitoring these patients.

“HBV reactivation is usually associated with immunosuppression,” Bersoff-Matcha said. “However, the DAAs are not immunosuppressive and treating physicians may not readily associate DAA therapy with HBV reactivation.”

This prompted the FDA to issue its Drug Safety Communication on Oct. 4, 2016 that summarizes the FDA’s position, according to Bersoff-Matcha. “This includes advice to screen all patients for evidence of current or prior HBV infection before starting treatment with DAAs, and monitor patients using blood tests for HBV flare-ups or reactivation during treatment and post-treatment follow up,” she said. – by Rob Volansky

Reference:

Bersoff-Matcha SJ, et al. Abstract LB-17. Presented at: The Liver Meeting; Nov. 11-15, 2016; Boston.

Disclosures: Bersoff-Matcha reports no relevant financial disclosures.