Early on-treatment prediction of response to peginterferon alfa-2a ...

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Hepatology. 2010 Aug;52(2):454-61.

Early on-treatment prediction of response to peginterferon alfa-2a for
HBeAg-negative chronic hepatitis B using HBsAg and HBV DNA levels.

Rijckborst V, Hansen BE, Cakaloglu Y, Ferenci P, Tabak F, Akdogan M, Simon K,
Akarca US, Flisiak R, Verhey E, Van Vuuren AJ, Boucher CA, Ter Borg MJ,
Janssen HL.

Gastroenterology and Hepatology,, Erasmus MC-University Medical Center,
Rotterdam, the Netherlands.

Abstract
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.

(HEPATOLOGY 2010).
PMID: 20683945



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