Abstract
Information on the efficacy of pegylated interferon (PEG-IFN) treatment of chronic hepatitis B (CHB) patients and predictors of the response based on real-world data is limited. Consecutive 201 patients who underwent PEG-IFN treatment for CHB were reviewed. A virological response (VR) was defined as a serum HBV DNA of <2000 IU/mL, and a combined response (CR) was defined a VR accompanied by serological response for hepatitis B e antigen (HBeAg)-positive CHB. For HBeAg-positive CHB patients, the HBeAg seroconversion rate and CR rate were 30.5% and 21.2% at 48 weeks after end of treatment (EOT), respectively. Baseline alanine aminotransferase (ALT) level was associated with HBeAg seroconversion, while baseline hepatitis B s antigen (HBsAg) levels of <250 IU/mL and HBV DNA <2.5 × 107 IU/mL were strongly associated with sustained off-treatment CR. For HBeAg-negative CHB, the VR rates were 85.5%, and 27.7% at EOT, and 48 weeks after EOT, respectively; a baseline HBsAg <1,250 IU/mL was associated with sustained off-treatment VR. PEG-IFN treatment has durable HBeAg seroconversion in HBeAg-positive CHB, but results in a high risk of relapse among HBeAg-negative CHB patients. Pre-treatment HBsAg level is an important predictor of VR in CHB patients undergoing PEG-IFN treatment.
Highlights
The treatment options for chronic hepatitis B include nucleoside or nucleotide analogues (NUCs), and interferon (IFN) or pegylated interferon (PEG-IFN) based on current treatment guidelines[4,5,6]
Several prediction factors are known to be associated with treatment response among PEG-IFN treated patients based on previous clinical trials
In HBeAg-positive CHB patients, a high alanine aminotransferase (ALT) level, a low Hepatitis B virus (HBV) viral load at baseline, genotype A HBV, and a decline in serum hepatitis B surface antigen (HBsAg) level during the treatment have been associated with a clinical response in previous studies[14,15,16,17]
Summary
The treatment options for chronic hepatitis B include nucleoside or nucleotide analogues (NUCs), and interferon (IFN) or pegylated interferon (PEG-IFN) based on current treatment guidelines[4,5,6]. Several prediction factors are known to be associated with treatment response among PEG-IFN treated patients based on previous clinical trials. In HBeAg-positive CHB patients, a high alanine aminotransferase (ALT) level, a low HBV viral load at baseline, genotype A HBV, and a decline in serum HBsAg level during the treatment have been associated with a clinical response in previous studies[14,15,16,17]. The aim of this study was to analyze the factors associated with a sustained off-treatment response to PEG-IFN α2a based treatment using a real-world cohort of CHB patients from two medical centers in Taiwan, and to develop a model for identifying patients who have the best chance of responding to PEG-IFN treatment in clinical practice
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