Quantitative hepatitis B surface antigen and hepatitis B e antigen titers in prediction of treatment response to entecavir

Abstract

Quantitative hepatitis B surface antigen (qHBsAg) and quantitative hepatitis B e antigen (qHBeAg) titers are emerging as useful tools for measuring viral loads and for predicting the virological response (VR) and serological response (SR) to pegylated interferon therapy. However, the clinical utility of these assays in patients taking entecavir (ETV) is largely unknown. Treatment-naive patients with chronic hepatitis B (CHB) who were taking ETV for 2 years were enrolled. The qHBsAg and qHBeAg levels were serially measured with the Architect assay. From 95 patients, 60.0% of whom were hepatitis B e antigen-positive [HBeAg(1)], 475 samples were analyzed. The median baseline log hepatitis B virus (HBV) DNA, log qHBsAg, and log qHBeAg values were 6.73 copies/mL (4.04-9.11 copies/mL), 3.58 IU/mL (1.17-5.10 IU/ mL), and 1.71 Paul Ehrlich (PE) IU/mL (20.64 to 2.63 PE IU/mL), respectively. For the prediction of VR (HBV DNA < 60 copies/mL at 24 months) in HBeAg(1) patients, baseline alanine aminotransferase (P 5 0.013), HBV DNA (P 5 0.040), and qHBsAg levels (P 5 0.033) were significant. For the prediction of VR, the area under the curve for the baseline log qHBsAg level was 0.823 (P < 0.001); a cutoff level of 3.98 IU/mL (9550 IU/mL on a nonlogarithmic scale) yielded the highest predictive value with a sensitivity of 86.8% and a specificity of 78.9%. As for SR (HBeAg loss at 24 months), the reduction of qHBeAg was significantly greater in the SR(1) group versus the SR(2) group. The sensitivity and specificity were 75.0% and 89.8%, respectively, with a decline of 1.00 PE IU/mL at 6 months. With ETV therapy, the correlation between HBV DNA and qHBsAg peaked at 6 months in HBeAg(1) patients. Conclusion: Both qHBsAg and qHBeAg decreased significantly with ETV therapy. The baseline qHBsAg levels and the on-treatment decline of qHBeAg in HBeAg(1) patients were proven to be highly useful in predicting VR and SR, respectively. The determination of qHBsAg and qHBeAg can help us to select the appropriate strategy for the management of patients with CHB. However, the dynamic interplay between qHBsAg, qHBeAg, and HBV DNA during antiviral therapy remains to be elucidated. (HEPATOLOGY 2011;53:1486-1493 C hronic infection with hepatitis B virus (HBV) is a worldwide health problem, with more than 400 million people thought to be infected.Moreover, these patients are at increased risk for disease progression to cirrhosis and hepatocellular carcinoma. 1 Large cohort studies have shown that elevated levels of Abbreviations: ALT, alanine aminotransferase; anti-HBs, antibody to hepatitis B surface antigen; AUC, area under the curve; AUROC, area under the receiver operating characteristic

Kronik Hepatit B Enfeksiyonu Olan Hastalarda HBsAg ve HBeAg Değerlerinin HBV DNA ve Alanin Aminotransferaz Düzeyleri ile Karşılaştırılması

“…Bir çok çalışmada HBsAg ve HBeAg değerleri benzer şekilde ölçülerek tedavinin izlenmesinde kullanılabilirlikleri değerlendirilmiştir (6,7,9,10,12,13,17,18). Ancak bu çalışmada hastalardan eş zamanlı alınan serum örneklerinde HBsAg, HBeAg ölçüm değerleri HBV DNA ve ALT düzeyleri ile karşılaştırılmış ve sonuçların araştırıcılar için yol gösterici olacağı düşünülmüştür.…”

Increasing the Efficiency of Laboratory Performance by Using the Onboard Dilution Algorithm of the Elecsys Hepatitis B Surface Antigen II Quantitative Assay

“…The quantification of hepatitis B surface antigen (HBsAg) and hepatitis B virus (HBV) DNA levels is expected to play an important role in predicting and evaluating antiviral therapy responses in patients with chronic HBV hepatitis [1,2]. Recent studies suggested that the slow kinetics of covalently closed circular DNA (cccDNA) under powerful antiretroviral treatment is a main cause of viral rebound after interruption of longterm therapy [3,4].…”

Virus and Host Testing to Manage Chronic Hepatitis B

“…In HBeAg-positive patients, those who have HBeAg loss tend to have a faster decline in HBsAg level, but the value of serum HBsAg to determine treatment cessation is uncertain [26,27]. In HBeAg-negative patients, small studies in Hong Kong and Taiwan suggested that serum HBsAg <100-200 IU/mL can predict sustained response and HBsAg seroclearance after stopping lamivudine, but these results need to be validated in bigger studies and other patient populations (Table 4) [28,29].…”