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Low Rate of Hepatitis B Reactivation Among Patients with Chronic Hepatitis C During Direct Acting Antiviral Therapy
Nehna Abdul Majeed1, Ahmad Samer Alawad1, Kin Seng Liem2,3,4
1Liver Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD, USA.
Insights
Hepatitis B virus (HBV) reactivation risk is low in chronic hepatitis C (CHC) patients treated with direct-acting antivirals (DAAs). Monitoring HBV DNA is recommended only for selected patients with abnormal ALT levels during DAA therapy.
Area of Science:
- Hepatology
- Virology
- Pharmacology
Background:
- Hepatitis B virus (HBV) reactivation is a concern in patients co-infected with Hepatitis C virus (HCV) during direct-acting antiviral (DAA) therapy.
- The U.S. FDA issued a black box warning recommending HBV reactivation monitoring for all DAA labels.
Purpose of the Study:
- To evaluate the rate of HBV reactivation in patients with chronic hepatitis C (CHC) receiving DAA therapy.
- To assess the clinical significance of HBV reactivation during DAA treatment.
Main Methods:
- Included CHC patients with resolved HBV infection (HBsAg negative/anti-HBc positive) treated with DAAs.
- Tested stored sera for HBV DNA, HBsAg, and ALT.
- Defined HBV reactivation by changes in HBV DNA detectability or quantification post-therapy.
Main Results:
- 8 out of 79 (10%) patients experienced HBV reactivation during or after DAA therapy.
- Reactivation occurred more frequently in men.
- No ALT flares or HBsAg seroreversion were observed; detectable HBV DNA was transient in most cases.
Conclusions:
- The risk of HBV reactivation is low in CHC patients with resolved HBV infection undergoing DAA therapy.
- HBV DNA testing is suggested only for selected patients exhibiting ALT flares or failure of ALT normalization during DAA treatment.
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.
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