Efficacy of pegylated interferon alpha in treating postpartum women with chronic hepatitis B virus infection: a multicenter prospective study.

OBJECTIVE

Hepatitis B surface antigen (HBsAg) clearance is a key milestone for functional (clinical) cure of chronic hepatitis B virus (HBV) infection. However, data on the efficacy and safety of pegylated interferon alpha (Peg-IFNα) for HBsAg clearance in postpartum women with chronic HBV infection remain scarce. This study aimed to prospectively evaluate the efficacy and safety of Peg-IFNα in promoting HBsAg clearance in this specific population.

METHODS

A total of 263 HBV-infected postpartum women with a baseline HBsAg levels ≤3000 IU/mL were enrolled. Based on patient preference, they were assigned to either the Peg-IFNα group (n=62, receiving Peg-IFNα monotherapy or combination therapy with nucleos(t)ide analogs [NAs]) or the control group (n=201, receiving NAs or follow-up only). The duration of Peg-IFNα treatment was ≥48 weeks. Propensity score matching (PSM) was performed to balance baseline characteristics. The primary endpoints were both HBsAg clearance rate and the magnitude of HBsAg decline.

RESULTS

At week 48, the Peg-IFNα group had significantly higher HBsAg clearance (29.03% [18/62]) and seroconversion rates (27.42% [17/62]) than the control group (both 0%, P < 0.001). Post-PSM, the Peg-IFNα group still had a significantly higher HBsAg clearance/seroconversion rate (30.43% [14/46]) versus the control group (0%, P < 0.001). Subgroup analysis showed that patients with baseline HBsAg < 1000 IU/mL had higher clearance rates (pre-PSM: 39.02% [16/41]; post-PSM: 40.00% [12/30]). Receiver operating characteristic (ROC) curve analysis identified a ≥ 99.2% HBsAg reduction from baseline to week 12 as a strong predictor of week 48 HBsAg clearance (AUC ≥0.9; sensitivity =0.818; specificity= 1.000).

CONCLUSION

Peg-IFNα treatment can achieve high rates of HBsAg clearance and seroconversion in postpartum women with chronic HBV infection. The postpartum period represents a unique and favorable immune window for interferon-based intervention, and patients with baseline HBsAg <1000 IU/mL derive particular benefit from this strategy.