Immunomodulatory and Antiviral Therapy Improved Functional Cure Rate in CHB Patients with High HBsAg Level Experienced NA
JOURNAL OF CLINICAL AND TRANSLATIONAL HEPATOLOGY(2023)
摘要
Background and AimsA functional cure, or hepatitis B virus (HBV) surface antigen (HBsAg) loss, is difficult to achieve in patients with hepatitis B virus e antigen (HBeAg)-positive chronic hepatitis B. The HBV vaccine and granulocyte-macrophage colony-stimulating factor (GM-CSF) have been reported to help reduce HBsAg levels and promote HBsAg loss. In this prospective randomized trial, we evaluated HBsAg loss in patients receiving pegylated interferon-alpha 2b (PEGIFN-alpha 2b) and tenofovir disoproxil fumarate (TDF), with and without GM-CSF and HBV vaccination.MethodsA total of 287 patients with HBeAg positive chronic hepatitis B and seroconversion after nucleot(s)ide analog treatment were assigned randomly to three treatment groups for 48 weeks, TDF alone (control), PEGIFN-alpha 2b + TDF, and PEGIFN-alpha 2b + TDF + GM-CSF + HBV vaccine. The primary endpoints were the proportions of patients with HBsAg loss and seroconversion at 48 and 72 weeks.ResultsThe cumulative HBsAg loss rates in the control, PEGIFN-alpha 2b + TDF, and PEGIFN-alpha 2b + TDF + GM-CSF + HBV vaccine groups at week 48 were 0.0%, 28.3%, and 41.1%, respectively. The cumulative HBsAg seroconversion rates in these groups at week 48 were 0.0%, 21.7%, and 33.9%, respectively. Multivariate regression analysis showed that GM-CSF use plus HBV vaccination was significantly associated with HBsAg loss (p=0.017) and seroconversion (p=0.030).ConclusionsIn patients with HBeAg-positive chronic hepatitis B and seroconversion after nucleot(s)ide analog treatment, immunomodulatory/antiviral treatment regimens effectively improved HBsAg loss, and the regimen including GM-CSF and HBV vaccination was most effective.
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关键词
Chronic hepatitis B,HBsAg loss,Functional cure,Immunomodula-tory,antiviral therapy,Pegylated interferon-?2b,Tenofovir disoproxil fumarate,Granulocyte-macrophage colony-stimulating factor,Hepatitis B virus vaccine
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