Efficacy and safety of peginterferon alpha monotherapy in Chinese inactive chronic hepatitis B virus carriers
Fengping Wu 1 , Rui Lu 1 , Yixin Liu 1 , Yikai Wang 1 , Yan Tian 1 , Yaping Li 1 , Mei Li 1 , Wenjun Wang 1 , Xin Zhang 1 , Xiaoli Jia 1 , Shuangsuo Dang 1
Affiliations
Affiliation
1
Department of Infectious Diseases, the Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, 710004, China.
PMID: 33896094 DOI: 10.1111/liv.14897
Abstract
Background &aims: The effectiveness and safety of peginterferon alpha (peg-IFN-α) monotherapy in inactive hepatitis B virus (HBV) carriers (IHCs) have not been fully evaluated.
Methods: This observational study prospectively enrolled 298 IHCs in China from 2015 to 2019. Participants were given the right to choose to either receive peg-IFN-α monotherapy (treatment group, n=142) or be monitored without treatment (control group, n=156) according to their wishes. The scheduled treatment duration was 48 weeks. All participants were followed up to 72 weeks. The main efficacy endpoint was Hepatitis B surface antigen (HBsAg) clearance at 72 weeks.
Results: Baseline characteristics were similar between both groups. At 72 weeks, intention-to-treat analysis showed that the rates of HBsAg clearance and seroconversion of the treatment group were 47.9% (68/142) and 36.6% (52/142), respectively, which were significantly higher than the HBsAg clearance rate of 1.9% (3/156) and the seroconversion rate of 0.6% (1/156) in the control group (both P < 0.001). Baseline HBV DNA< 20 IU/mL, lower HBsAg levels at baseline, 12 weeks and 24 weeks, alanine aminotransferase elevation at 12 weeks, and greater HBsAg reduction from baseline to 12 weeks and 24 weeks were independent predictors of HBsAg clearance. Generally, the therapy was well tolerated. Only 5 participants discontinued therapy as a result of peg-IFNα-related adverse events.
Conclusion: Peg-IFN-α monotherapy results in high rates of HBsAg clearance and seroconversion and the treatment is safe for IHCs.
结果：两组的基线特征相似。在72周时，意向性治疗分析显示，治疗组的HBsAg清除率和血清转化率分别为47.9％（68/142）和36.6％（52/142），显着高于HBsAg清除率对照组的血清转化率为1.9％（3/156），血清转化率为0.6％（1/156）（均P <0.001）。基线HBV DNA <20 IU / mL，基线，12周和24周时HBsAg水平降低，12周时丙氨酸转氨酶升高，基线至12周和24周时HBsAg降低更多是HBsAg清除率的独立预测指标。通常，该疗法具有良好的耐受性。由于peg-IFNα相关的不良事件，只有5名参与者中止了治疗。