HBsAg Clearance in Inactive Chronic HBsAg Carriers After Interferon Treated
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional

Summary: 
      Hepatitis B surface antigen loss/seroconversion, considered to be the ideal outcome of
      chronic hepatitis B virus (HBV) infection, occurs spontaneously at a low rate in inactive
      carriers.

      The researchers aim to investigate the ability of peginterferon alpha-2a to achieve surface
      antigen loss/seroconversion therapy in inactive carriers with persistently normal alanine
      aminotransferase (ALT) levels, undetectable HBV DNA and low surface antigen levels, who would
      not generally be considered candidates for therapy.
    

Detailed description: 
      Chronic HBV inactive carriers were enrolled in the out-patient department of Beijing Ditan
      Hospital. All of them were HBsAg positive and anti-HBs negative for more than 6 months with
      persistent undetectable HBV DNA and normal ALT levels measured at 3-6 monthly intervals
      during the preceding 2 years as well as with serum HBsAg levels ≤100 IU/mL determined on two
      occasions during the month prior to treatment. All patients did not have other liver diseases
      and contraindications for interferon therapy.

      After giving informed consent, patients were treated with weekly subcutaneous injections of
      peginterferon alpha-2a 180 µg. The use of other immune suppressive or regulatory drugs and
      other antiviral drugs was prohibited during the course of the study.

      In this study, the only parameter to assessing the treatment response was HBsAg level change.
      Treatment endpoint was HBsAg loss(<0.05 IU/mL) and anti-HBs positive(>10 mIU/mL) defined as
      seroconversion.

      Depending on the decline of HBsAg level, treatment was either continued for a prolonged
      period until the endpoint was achieved, or terminated in case of nonresponse. Treatment was
      proceeded if HBsAg level continued to decline until HBsAg seroconversion was achieved and the
      anti-HBs level was above 200 mIU/ml. If the patients were not willing to extend treatment,
      the therapy was ended at the time of HBsAg loss, or stopped without further decline of HBsAg
      levels on three months treatment.

      Liver function parameters, including ALT, aspartate aminotransferase (AST), albumin (ALB) and
      total bilirubin (Tbil) were examined using an automated biochemical analyzer. Peripheral
      blood neutrophil and platelet count were detected before treatment, and monitored during
      treatment with one to three month intervals, and base on the test results to adjust the next
      checking time. Quantitative HBV DNA testing was conducted using a commercially available
      real-time fluorescence quantitative PCR kit. HBsAg levels were quantified with Architect
      i2000 HBsAg quantitative assay (Abbott Laboratories) kit.

      The main efficacy endpoints were HBsAg loss and seroconversion.
    

Intervention name(s): Pegylated interferon alfa-2a
Intervention type(s): Drug
Intervention description(s): patients were given peginterferon alfa-2a (40KD) (Pegasys®; Roche, Basel, Switzerland)180 µg by subcutaneous injection once weekly for 120 weeks
Other intervention name(s): Pegasys®; Roche, Basel, Switzerland
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic hepatitis B