J Viral Hepat. 2019 Aug 25. doi: 10.1111/jvh.13195. [Epub ahead of print]
Baseline and kinetics of serum HBV RNA predict response to pegylated interferon-based therapy in patients with HBeAg-negative chronic hepatitis B.
Limothai U1, Chuaypen N1, Poovorawan K2, Chotiyaputta W3, Tanwandee T3, Poovorawan Y4, Tangkijvanich P1.
Author information
1
Center of Excellence in Hepatitis and Liver Cancer, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
2
Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.
3
Department of Medicine, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.
4
Center of Excellence in Clinical Virology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Abstract
Serum hepatitis B virus (HBV) RNA has emerged as a novel biomarker of treatment response. This study aimed to investigate the role of this marker in predicting long-term outcome of patients with HBeAg-negative chronic hepatitis B (CHB) receiving pegylated interferon (PEG-IFN)-based therapy. Serial serum samples from 91 patients with HBeAg-negative CHB previously treated with PEG-IFN alone or combined with entecavir in a randomized trial were retrospectively analyzed. HBV RNA quantification was examined by droplet digital PCR. At the end of 3 years post-treatment follow-up, maintained virological response (MVR, HBV DNA <2,000 IU/mL), and HBsAg clearance were achieved in 37.4% (34/91) and 7.7% (7/91), respectively. Baseline serum HBV RNA concentrations correlated with HBV DNA and cccDNA but did not correlate with HBsAg levels. Multiple regression analysis showed that pretreatment HBV RNA and HBsAg were independently associated with MVR and HBsAg clearance. Baseline HBV RNA (cut-off 2.0 log10 copies/mL) had a positive predictive value (PPV) and a negative predictive value (NPV) in predicting MVR of 80.8% and 80.0%, respectively. At the same cut-off value, PPV and NPV for predicting HBsAg clearance were 30.8% and 95.4%, respectively. At week 12 during therapy, HBV RNA level ≥ 2 log10 copies/mL displayed high NPVs of achieving MVR and HBsAg clearance (95% and 100%, respectively). In conclusion, the measurement of HBV RNA prior to PEG-IFN-based therapy could identify patients with high probability of MVR. In addition, HBV RNA kinetics may serve as a promising 'stopping rule' in patients infected with HBV genotypes B or C. This article is protected by copyright. All rights reserved.
This article is protected by copyright. All rights reserved.
KEYWORDS: