Peginterferon alfa-2a results in a sustained response (SR) in a minority of patients with hepatitis B e antigen (HBeAg)-negative chronic hepatitis B (CHB). This study investigated the role of early on-treatment serum hepatitis B surface antigen (HBsAg) levels in the prediction of SR in HBeAg-negative patients receiving peginterferon alfa-2a. HBsAg (Architect from Abbott) was quantified at the baseline and during treatment (weeks 4, 8, 12, 24, 36, and 48) and follow-up (weeks 60 and 72) in the sera from 107 patients who participated in an international multicenter trial (peginterferon alfa-2a, n = 53, versus peginterferon alfa-2a and ribavirin, n = 54). Overall, 24 patients (22%) achieved SR [serum hepatitis B virus (HBV) DNA level < 10,000 copies/mL and normal alanine aminotransferase levels at week 72]. Baseline characteristics were comparable between sustained responders and nonresponders. From week 8 onward, serum HBsAg levels markedly decreased in sustained responders, whereas only a modest decline was observed in nonresponders. However, HBsAg declines alone were of limited value in the prediction of SR [area under the receiver operating characteristic curve (AUC) at weeks 4, 8, and 12 = 0.59, 0.56, and 0.69, respectively]. Combining the declines in HBsAg and HBV DNA allowed the best prediction of SR (AUC at week 12 = 0.74). None of the 20 patients (20% of the study population) in whom a decrease in serum HBsAg levels was absent and whose HBV DNA levels declined less than 2 log copies/mL exhibited an SR (negative predictive value = 100%). Conclusion: At week 12 of peginterferon alfa-2a treatment for HBeAg-negative CHB, a solid stopping rule was established with a combination of declines in serum HBV DNA and HBsAg levels from the baseline. Quantitative serum HBsAg in combination with HBV DNA enables on-treatment adjustments of peginterferon therapy for HBeAg-negative CHB.

Additional Metadata
Keywords Adult, Antiviral Agents, DNA, Viral, Double-Blind Method, Female, Hepatitis B Surface Antigens, Hepatitis B e Antigens, Hepatitis B virus, Hepatitis B, Chronic, Humans, Interferon Alfa-2a, Male, Polyethylene Glycols, Predictive Value of Tests, Remission Induction, Retrospective Studies, Time Factors, adult, alanine aminotransferase, alanine aminotransferase blood level, area under the curve, article, controlled study, female, hepatitis B, hepatitis B surface antigen, hepatitis B(e) antigen, human, human tissue, major clinical study, male, peginterferon alpha2a, placebo, priority journal, ribavirin, treatment response, virus DNA
Persistent URL,
Journal Hepatology
Rijckborst, V, Hansen, B.E, Cakaloglu, Y, Ferenci, P, Tabak, F, Akdogan, M, … Janssen, H.L.A. (2010). Early on-treatment prediction of response to peginterferon alfa-2a for HBeAg-negative chronic hepatitis B using HBsAg and HBV DNA levels. Hepatology, 52(2), 454–461. doi:10.1002/hep.23722