A Potential Functional Cure in Chinese HBeAg-negative Chronic Hepatitis B Patients Treated with Peg-interferon Alpha-2a

Abstract

Background and Aims: Data are limited on the use of pegylated-interferon alpha-2a (peg-IFNα) in Chinese patients with chronic hepatitis B virus (HBV) infection (CHB). We evaluated the effectiveness and safety of peg-IFNα in Chinese patients with hepatitis B envelope antigen-negative CHB in routine clinical practice. Methods: In this prospective, multicenter, observational, non-interventional cohort study, patients were assessed for up to 1 year after peg-IFNα treatment cessation. Treating physicians established the dosing and treatment duration according to Chinese clinical practice. Effectiveness of peg-IFNα treatment was measured by the percentage of: patients with HBV DNA <2000 IU/mL and loss of hepatitis B surface antigen (commonly known as HBsAg); HBV DNA level at end of treatment (EOT), and 6 months and 1 year posttreatment; and time course change in quantitative HBV DNA and HBsAg. Results: At EOT, 6 months posttreatment, and 1 year posttreatment, the percentage of patients with HBV DNA <2000 IU/mL was 90.0%, 81.8%, and 82.2%, and that of patients with HBsAg loss was 6.5%, 9.4%, and 9.5%, respectively. The HBV DNA level decreased from 5.61 log IU/mL at baseline to 2.48 log IU/mL at EOT and 2.67 log IU/mL at 1 year posttreatment. The HBsAg level decreased from 3.08 log IU/mL at baseline to 2.24 log IU/mL at EOT and 2.10 log IU/mL at 1 year posttreatment. The incidence of adverse events was 52.0%. Conclusions: Peg-IFNα has the potential to provide functional cure (HBsAg loss) for CHB and is well tolerated in hepatitis B envelope antigen-negative CHB patients in routine clinical practice in China. Clinical Trial Registration: ClinicalTrials.gov (NCT01730508).

Keywords: Chronic hepatitis B; Interferon alpha; Observational study; Prospective studies.

Conflict of interest statement

Qianguo Mao has received grants and Jidong Jia has received grants and personal fees from Shanghai Roche Pharmaceuticals Ltd. during the conduct of this study. Yan Huang is an employee of Shanghai Roche Pharmaceuticals Ltd. The other authors have no conflict of interests related to this publication.

© 2019 Authors.

Figures

Fig. 1.. Patient disposition.

The predefined date to stop data collection was at 1 year after the last enrolled patient completed the treatment. At the final cut-off (date to stop data collection), 13 patients who received prolonged treatment were still within the 1 year follow-up window. Abbreviations: AE, adverse event; FAS, full analysis set; FAS-MSC, full analysis set of those who meet selection criteria; NUC, nucleoside analogue; peg-IFNα, pegylated-interferon alpha-2a; tx, treatment.

Fig. 2.. Percentage of patients with HBV DNA <2000 IU/mL, <400 IU/mL, and <200 IU/mL, that of patients with a combined response (HBV DNA <2000 IU/mL and ALT normalization), and that of patients with HBsAg loss and HBsAg seroconversion at EOT, 6 months posttreatment, and 1 year posttreatment (A), as well as changes in HBsAg category (B), time course change of mean HBV DNA (C), and time course change of mean HBsAg (D). The error bars in 2A indicate 95% confidence intervals and those in C and D indicate standard errors. The mean values in C and D were calculated using the data of the FAS-MSC.

Abbreviations: ALT, alanine aminotransferase; EOT, end of treatment; FAS-MSC, full analysis set of those who met the selection criteria; HBsAg, hepatitis B surface antigen; HBV, hepatitis B virus; ULN, upper limit of normal.

Fig. 3.. Changes in HBsAg by subgroup according to ALT (FAS-MSC) (A), age (B), treatment duration (C), and treatment response (D).

The error bars indicate standard errors. Abbreviations: ALT, alanine aminotransferase; FAS-MSC, full analysis set of those who met the selection criteria; HBsAg, hepatitis B surface antigen; HBV, hepatitis B virus; ULN, upper limit of normal.