A one-time test combining hepatitis B virus (HBV) surface antigen and HBV DNA measurement accurately distinguished inactive carriers from active cases of chronic HBV, based on data from 1,529 patients published online in the journal Hepatology.
Correct identification of active chronic HBV patients vs. inactive cases “is a crucial step in identifying patients in need of less stringent follow-up, as well as patients who may benefit from additional follow-up and earlier initiation of antiviral therapy,” wrote Dr. Jessica Liu of the Genomics Research Center, Academia Sinica, in Taipei, Taiwan, and her colleagues (Hepatology. 2016. doi: 10.1002/hep.28552).
CDC/Dr. Erskine Palmer
The investigators reviewed data from patients in the REVEAL-HBV cohort, which included individuals aged 30-65 years with chronic HBV who were recruited between 1991 and 1992. All patients were free of liver cirrhosis and were seronegative for anti–hepatitis C virus and hepatitis B surface antigen (HBsAg) at baseline, and were characterized as inactive carriers or active cases based on their serologic profiles at 18 months’ follow-up. Blood was collected at study entry and every 6-12 months.
At 18 months’ follow-up, the combined test distinguished inactive carriers from active cases with a sensitivity of 71% and a specificity of 85%. The positive and negative predictive values were 83% and 74%, respectively, and the diagnostic accuracy was 78%. In addition, the one-time combination measurement predicted cirrhosis, hepatocelluar carcinoma, and HBsAg seroclearance with areas under the receiver operating characteristic curves of 0.72, 0.79, and 0.78, respectively. The combination test also yielded information about the predictability of inactive carrier status, showing that inactive carriers had a significantly lower risk of cirrhosis and hepatocelluar carcinoma; adjusted hazard ratios were 0.43 and 0.13, respectively.
“To our knowledge, this is the first study to externally validate the usage of a one-time measurement of serum HBsAg less than 1,000 IU/mL and HBV DNA less than 2,000 IU/mL,” the researchers wrote.
The study was limited by a relatively short follow-up period, but the results suggest that “this single-point strategy may provide new and complementary information useful for simplifying or tailoring management of patients with chronic hepatitis B infection,” they said.
The study was supported by the Taiwan Department of Health, Bristol-Myers Squibb, Roche Diagnostics, and Academia Sinica. One of the coauthors is employed by Roche Diagnostics.