Low Rate of Hepatitis B Reactivation Among Patients with Chronic Hepatitis C During Direct Acting Antiviral Therapy

Nehna Abdul Majeed, Ahmad Samer Alawad, Kin Seng Liem, Varun Takyar, Harvey Alter, Jordan J. Feld, Harry L.A. Janssen, Marc G. Ghany*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

1 Citation (Scopus)


Background and Aims: Hepatitis B virus (HBV) reactivation has been reported in patients co-infected with hepatitis C virus (HCV) during direct acting antiviral (DAA) therapy, leading the United States Food and Drug Administration (U.S. FDA) to issue a black box warning on all DAA drug labels recommending monitoring for HBV reactivation. We conducted a comprehensive evaluation to assess the rate of HBV reactivation among patients with chronic hepatitis C (CHC) during DAA therapy. Methods: Patients with CHC and recovered HBV infection (hepatitis B surface antigen negative (HBsAg)/anti-hepatitis B core positive), treated with DAAs were included if stored sera were available. Samples were tested for HBV DNA, HBsAg, and ALT. HBV reactivation was considered if (1) HBV DNA was undetectable pre-DAA therapy and became detectable post-therapy, or (2) HBV DNA was detectable pre-treatment, but not quantifiable (< 20 IU/mL) and became quantifiable post-treatment. Result: 79 patients with median age of 62 years were included. 68% were male and Caucasian. Various DAA regimens were administered for 12–24 weeks. Reactivation occurred in 8/79 (10%) of patients and occurred more frequently in men compared to women: 6 during treatment and 2 after treatment. Neither an ALT flare nor HBsAg seroreversion were observed. Detectable HBV DNA was transient in 5/8 and could not be determined in 3/8 but ALT flares were not observed in follow-up of these patients. Conclusion: The risk of HBV reactivation was low in CHC patients with resolved HBV during DAA therapy. Our data support testing for HBV DNA only in selected patients with ALT flares or failure of ALT normalization during DAA treatment.

Original languageEnglish
Pages (from-to)3193-3198
Number of pages6
JournalDigestive Diseases and Sciences
Issue number7
Publication statusPublished - Jul 2023

Bibliographical note

Funding Information:
The study was supported by the Intramural Research Program, National Institute of Diabetes and Digestive and Kidney Diseases.

Publisher Copyright:
© 2023, This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.


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