Outcome of Chinese Patients with Hepatitis B at 96 Weeks after Functional Cure With IFN versus Combination Regimens.

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 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).