A baseline tool for predicting response to peginterferon alfa‐2a in HBeAg‐positive patients with chronic hepatitis B

Abstract

Background Peginterferon induces off‐treatment responses in approximately one‐third of patients with hepatitis B e antigen (HBeAg)‐positive chronic hepatitis B. Aim To develop an easy‐to‐use baseline prediction score to identify hepatitis B virus (HBV) genotype B‐/C‐infected HBeAg‐positive Asian patients likely to respond to peginterferon alfa‐2a. Methods Generalised additive models, multiple logistic regression (MLR) analysis and internal validation methods were applied to data from 647 HBeAg‐positive patients from China, Hong Kong and Taiwan to develop a scoring system to predict response 24 weeks after completing a 48‐week course of peginterferon alfa‐2a. Results Five baseline factors (age, sex, alanine aminotransferase ratio, hepatitis B surface antigen (HBsAg) level and HBV DNA level) were retained in the final MLR for HBeAg seroconversion and used to develop a scoring system from 0 to 7. Among patients with scores of 0‐1, 2‐3, 4 or ≥5, HBeAg seroconversion was achieved in 6.4% (6/94), 23.0% (61/265), 36.4% (67/184) and 54.8% (57/104), respectively, and a combined response (HBeAg seroconversion plus HBV DNA <2000 IU/mL) in 5.3% (5/94), 12.8% (34/265), 25.0% (46/184) and 36.5% (38/104), respectively. Among patients with scores of 0‐1, 2‐3, 4 or ≥5, 57.0% (53/93), 12.3% (31/253), 3.4% (6/178) and 1.0% (1/100) had HBsAg ≥20 000 IU/mL at treatment Week 12; only 3/91 (3.3%) with HBsAg ≥20 000 IU/mL experienced a combined response at 24 weeks post‐treatment (negative predictive value = 97% [88/91]). Conclusion A pre‐treatment scoring system using readily available baseline characteristics identifies HBeAg‐positive Asian patients likely to experience sustained HBeAg seroconversion after treatment with peginterferon alfa‐2a.