HBV DNA testing in chronic hepatitis B (CHB) management

HBV DNA is a measure of viral replication and guides clinical decisions, but levels can fluctuate¹:

Serial monitoring is more reliable than cutoff values¹
Levels should be interpreted alongside other clinical variables¹

Who to Test

BEFORE TREATMENT

At baseline:

At diagnosis to determine phase of infection and eligibility for treatment^2,3
All CHB patients to assess viral replication¹
Individuals with abnormal liver enzymes or signs of liver disease¹
Pregnant women who are HBsAg+ to assess risk of vertical transmission¹

Annually or biannually after the first year:

For untreated patients to monitor disease activity and progression¹

DURING TREATMENT

Please see Prescribing Information for any treatment-specific monitoring requirements.

Every 3–6 months:

Patients undergoing immunosuppressive therapy or chemotherapy (at risk of HBV reactivation)¹
Individuals with HBeAg-negative CHB to detect occult viral replication¹

Before therapy cessation:

To confirm sustained viral suppression¹

INTERPRETING RESULTS AND NEXT STEPS

Interpreting CHB testing results and next steps table

HBV DNA and its association with long-term outcomes³

ACHIEVING HBV DNA SUPPRESSION HAS BEEN ASSOCIATED WITH A DECREASED RISK OF SERIOUS LIVER-RELATED OUTCOMES, INCLUDING:
Cirrhosis	Hepatic decompensation	Hepatocellular carcinoma	Liver transplantation	Death

In a retrospective cohort study that examined 20,263 patients, lack of complete viral suppression (HBV DNA undetectable) significantly increased the risk of HCC by 69% (aHR=1.69 [95% CI: 1.36–2.09]; P<0.001).⁴

Additionally, the risk of liver-related death was ~6x higher versus patients who did achieve complete viral suppression (aHR=6.85 [95% CI: 4.59–10.23]; P<0.001).⁴

*
Conditional recommendation based on very low evidence.¹
aHR=adjusted hazard ratio; ALT=alanine aminotransferase; CI=confidence interval; DNA=deoxyribonucleic acid; HBeAg=hepatitis B e-antigen; HBsAg+=hepatitis B surface antigen–positive; HBV=hepatitis B virus; NA=nucleos(t)ide analogue.

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References

Terrault NA, et al. Hepatology. 2018;67(4):1560-1599.
Screening and testing for hepatitis B virus infection: CDC recommendations – United States, 2023. Centers for Disease Control and Prevention. March 10, 2023. Accessed April 5, 2026. https://www.cdc.gov/mmwr/volumes/72/rr/rr7201a1.htm
European Association for the Study of the Liver. J Hepatol. 2025;83(2):502-583.
Yip TCF, et al. J Hepatol. 2019;70(3):361-370.

KEY BIOMARKER: HBV DNA testing