Hepatitis B Virus Reactivation Associated With Direct-Acting Antiviral Therapy for Chronic Hepatitis C Virus

Evaluation of hepatitis B reactivation among 62,920 veterans treated with oral hepatitis C antivirals

“…The lower incidence of concurrent hepatitis observed in this and similar cohorts suggests that reactivation of HBV in the setting of HCV DAA therapy may be less severe than that reported with immunosuppressive therapy where the reported incidence of hepatitis associated with HBV reactivation is as high as 30% . Despite the apparent lack of associated hepatitis flare associated with HBV reactivation in this cohort, other reports have described liver failure and death . Nonetheless, given the tolerability and safety of HBV antivirals and because some serious risk exists, it seems prudent to initiate HBV prophylaxis in patients who will be initiating DAA treatment and are HBsAg‐positive, regardless of serum HBV DNA.…”

“…Notably, there was an apparent lack of association with baseline HBV DNA levels as 3 of the 8 with reactivation had undetectable pre‐DAA HBV DNA levels. Although we could not assess for clinical symptoms in this evaluation, the potential risks observed here and described in previous reports of liver failure and death support prophylaxis in this setting . The lower incidence of concurrent hepatitis observed in this and similar cohorts suggests that reactivation of HBV in the setting of HCV DAA therapy may be less severe than that reported with immunosuppressive therapy where the reported incidence of hepatitis associated with HBV reactivation is as high as 30% .…”

“…Recently, several cases of hepatitis B virus (HBV) reactivation have been reported in patients receiving oral hepatitis C virus (HCV) antiviral therapy who were not already on HBV therapy, raising potential safety concerns . HBV reactivation is thought to be the consequence of the rapid treatment‐induced reduction in HCV, which is known to suppress HBV .…”

Real-world treatment of hepatitis C with second-generation direct-acting antivirals: initial results from a multicentre Canadian retrospective cohort of diverse patients

“…We did not observe any cases of HBV reactivation. 19 Significant predictors of not achieving an SVR identified by univariate analysis were older age, male sex, the presence of baseline cirrhosis and previous history of hepatocellular carcinoma. However, in multivariate modelling, only older age (adjusted OR 0.95 [95% CI 0.90-1.00]) and male sex (adjusted OR 0.30 [95% CI 0.10-0.89]) were associated with not achieving an SVR (Table 3).…”

Hepatitis B virus reactivation during direct‐acting antiviral treatment of chronic hepatitis C: A hidden danger of an otherwise major success story

“…Registration trials have convincingly shown that DAA treatment is far better tolerated than interferon/ribavirin‐based regimens. However, postapproval case series and a compilation of 24 international cases in the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) have demonstrated that HBV reactivation (HBVr) occurs during DAA treatment . The recent emergence of this adverse effect of DAAs is explainable by the exclusion of HBV‐coinfected individuals from registration trials.…”