Early clinical efficacy of pegylated interferon treatment in patients with different phases of chronic HBV infection: A real‐world analysis

Abstract

Although there are therapeutic advantages for hepatitis B virus (HBV) withpegylated interferon alpha (peg‐IFNα) treatment compared with nucleos(t)ide analog (NAs) therapy, the effect difference in infected population at different phases has not been well established. We studied the clinical efficacy of peg‐IFNα in two populations with HBV infection, including inactive HBsAg carrier (IHC) and chronic hepatitis B (CHB). A total of 328 HBV‐infected patients were included in this real‐world analysis. Patients were divided into two groups according to the infected stages. Peg‐IFNα monotherapy or combination therapy with NAs were used in IHCs, and peg‐IFNα added‐on NAs therapy was applied to patients with CHB. The primary efficacy endpoint was HBsAg loss at Week 24. Results: The Kaplan–Meier cumulative rates of HBsAg loss were 39.50% (n = 47/119) in IHC group and 28.71% (n = 60/209) in CHB group at Week 24 (p < .05). After Propensity Score Matching (PSM), the HBsAg loss rates were 36.84% (n = 35/95) and 32.63% (n = 31/95), respectively (p > .05). Patients with baseline HBsAg level < 100 IU/ml achieved higher rates of HBsAg clearance in IHC and CHB group (before PSM: 47.44% vs. 42.86%, after PSM: 49.12% vs. 45.83%, all p values > .05). Baseline HBsAg level and its level decline from baseline to Week 12 can be as the predictors for HBsAg loss at Week 24 in both groups. Hence, the efficacy of HBsAg clearance was broadly similar between IHCs and NA‐treated CHB patients during the early peg‐IFNα therapy. A significant downward trend of HBsAg level was observed in both groups during peg‐IFNα therapy.

The efficacy and safety of pegylated interferon α-2b-based immunotherapy for inactive hepatitis B surface antigen carriers

“…A recently published European study showed that 24-week HBsAg decline during PegIFNα-based treatment was superior to 12-week HBsAg decline for predicting subsequent HBsAg loss [23], which was confirmed in the present study. In addition, this study confirmed the conclusion that the lower the baseline HBsAg level, the higher the functional cure rate, as reported previously [12,13,24–27].…”

Clinical cure induced by pegylated interferon α-2b in the advantaged population of chronic hepatitis B virus infection: a retrospective cohort study

“…Emerging data suggest that baseline characteristics and the extent of early on-treatment HBsAg reduction may predict the possibility of HBsAg loss with Peg-IFN treatment ( Moucari et al., 2009 ; Rijckborst et al., 2010 ; Yeo et al., 2019 ). We found that baseline HBsAg level and HBsAg decline rates from baseline to 12 weeks and 24 weeks were all useful independent predictors of HBsAg clearance, which have been supported by many previous studies in individualized on-treatment decision-making ( Hu et al., 2018 ; Zheng et al., 2019 ; Zhang et al., 2023 ). In our study, the decline of HBsAg from baseline to 12 weeks and 24 weeks of more than 80% and 98% is a strong predictor of HBsAg clearance.…”

“…Recently, Zhang et al. ( Zhang et al., 2023 ) conducted a study about the comparison of Peg-IFN in NA-experienced patients and IHCs. They showed that the rates of HBsAg loss were 36.8% and 32.6% in the IHC group and NA add-on Peg-IFN group, respectively, after 24-week treatment, but their research lacked Peg-IFN-free control groups.…”