Outcome of Chinese patients with hepatitis B at 96 weeks after functional cure with IFN versus combination regimens.

Abstract

BACKGROUND & AIMS:

Nucleotides with add-on interferon treatment (NUC-IFN) provide significantly higher rates of hepatitis B surface antigen (HBsAg) loss in patients with chronic hepatitis B (CHB). This study aimed to investigate the sustainability of HBsAg loss and the prevention of clinical relapse.

METHODS:

Patients with CHB who achieved HBsAg loss and HBV DNA levels <20 IU/ml after IFN or NUC-IFN therapy were enrolled and followed up for 96 weeks. The primary outcome was HBsAg negativity without viremia at week 96. Secondary outcomes included virological or clinical relapse and predictors of relapse.

RESULTS:

420 patients were included in intention-to-treat analysis with 290 and 130 in the IFN and NUC-IFN groups respectively. At week 96, the intention-to-treat analysis revealed similar outcomes between groups, including HBsAg seroreversion (24.83% vs. 23.08%, P = .70), viremia (16.90% vs 13.08%, P = .32) and clinical relapse (11.38% vs 10.00%, P = .68); the per-protocol analyses also showed HBsAg seroreversion, viremia and clinical relapse in IFN group (15.50%, 6.59% and 0.39%) did not differ from those in NUC-IFN group (15.25%, 4.24% and 0.85%, P > .05). These outcomes were similar between patients who received entecavir and those who received telbivudine/lamivudine/adefovir before the combination therapy. In NUC-IFN-treated patients, fibrosis regression was observed at week 96. Baseline HBsAb negativity was independent predictors of HBsAg sero-reversion and recurrence of viremia in IFN treated group.

CONCLUSION:

NUC-IFN and IFN therapies are equally effective in achieving sustained functional cure and fibrosis regression. (ClinicalTrials.gov, Number NCT02336399).

• Authors: Calvin Q Pan, Ming-Hui Li, Wei Yi, Lu Zhang, Yao Lu, Hong-Xiao Hao, Gang Wan, Wei-Hua Cao, Xing-Yue Wang, Chong-Ping Ran, Ge Shen, Shu-Ling Wu, Min Chang, Yuan-Jiao Gao, Yao Xie
• Journal: Liver international : official journal of the International Association for the Study of the Liver (Liver Int) Vol. 41 Issue 7 Pg. 1498-1508 (07 2021) ISSN: 1478-3231 [Electronic] United States
• PMID: 33486874 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © 2021 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Chemical References

• Antiviral Agents
• DNA, Viral
• Hepatitis B Surface Antigens
• Hepatitis B e Antigens
• Interferon-alpha
• Polyethylene Glycols

Topics

• Antiviral Agents (therapeutic use)
• China
• DNA, Viral
• Hepatitis B (drug therapy)
• Hepatitis B Surface Antigens
• Hepatitis B e Antigens
• Hepatitis B virus (genetics)
• Hepatitis B, Chronic (drug therapy)
• Humans
• Interferon-alpha (therapeutic use)
• Neoplasm Recurrence, Local
• Polyethylene Glycols (therapeutic use)
• Treatment Outcome