Outcome of Chinese Patients with Hepatitis B at 96 Weeks after Functional Cure With IFN versus Combination Regimens
Calvin Q Pan 1 2 , Ming-Hui Li 3 4 , Wei Yi 5 , Lu Zhang 3 , Yao Lu 3 , Hong-Xiao Hao 3 , Gang Wan 6 , Wei-Hua Cao 3 , Xing-Yue Wang 3 , Chong-Ping Ran 3 , Ge Shen 3 , Shu-Ling Wu 3 , Min Chang 3 , Yuan-Jiao Gao 3 , Yao Xie 3 4
Affiliations
Affiliations
1
Center of Liver Diseases, Beijing Ditan Hospital, Capital Medical University, Beijing, 100015, China.
2
Division of Gastroenterology and Hepatology, Department of Medicine, NYU Langone Health, New York University School of Medicine, New York, NY, USA.
3
Department of Hepatology Division 2, Beijing Ditan Hospital, Capital Medical University, Beijing, China.
4
Department of Hepatology Division 2, Peking University Ditan Teaching Hospital, Beijing, China.
5
Department of Obstetrics and Gynecology, Beijing Ditan Hospital, Capital Medical University, Beijing, China.
6
Department of Medical and Biological Statistics, Beijing Ditan Hospital, Capital Medical University, Beijing, China.
PMID: 33486874 DOI: 10.1111/liv.14801
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 analyss revealed similar outcomes between groups, including HBsAg seroreversion (24.83% vs. 23.08%, p=0.70), viremia (16.90% vs. 13.08%, p=0.32) and clinical relapse (11.38% vs. 10.00%, p=0.68); 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>0.05). 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).
Keywords: HBsAg seroreversion; clinical relapse; hepatitis B flare; virological relapse.
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