A Cohort Study in Korean Patients With Chronic Hepatitis B (CHB) Receiving Pegylated Interferon
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Observational

Summary: 
      The current proposed study aims to bring answers following issues: the antiviral efficacy and
      safety profiles in Korean Chronic Hepatitis B (CHB) patients who are mostly infected with
      solely genotype C HBV, a proper duration of Pegasys® therapy post-treatment durability or
      accumulation of HBeAg seroconversion/HBsAg loss, preventable effect on long-term disease
      progression to liver cirrhosis and liver cancer. In addition, this study aims to collect more
      data on the efficacy and safety in a real-life clinical setting of Pegasys® therapy in
      patients with CHB.
    

Detailed description: 
      -  Korea is known to be an endemic area for HBV infection. Some studies have reported that
           more than 95% of patients in Korea with chronic HBV have genotype C infection.

        -  Compared with other genotypes, genotype C is associated with increased viral loads,
           higher histologic activity, more severe acute exacerbations, a longer viral clearance
           phase and worse antiviral response to peg-interferon therapy.

        -  Long-term nucleos(t)ide analogue (NA) therapy is recommended for chronic hepatitis B
           (CHB) patients with compensated and decompensated liver disease. However, a possibility
           of cessation of antiviral treatment with oral NAs is unlikely due to rebound of HBV DNA
           levels after termination of NAs administration. In addition, NA therapy has been
           reported to have lower chance of HBsAg seroclearance compared to that with
           immunomodulatory agents such as peginterferon.

        -  Pegasys® has been proved to induce HBsAg loss, which is the closest to cure of disease.
           However, a better understanding of HBV treatment with Pegasys® in the real-life clinical
           setting in Korea can be helpful for decision of treatment strategy in the future. Asian
           experience with Pegasys® therapy in CHB is limited. Study populations of
           investigator-initiated trials consist of selected group with smaller number of Korean
           patients. Therefore, long-term efficacy and safety data in real practice with Pegasys®
           treatment in both HBeAg-positive and -negative Korean patients are necessary.

        -  In addition, the current proposed collected data study may be helpful to bring answers
           to many unresolved issues: the antiviral efficacy and safety profiles in Korean CHB
           patients who are mostly infected with solely genotype C HBV, a proper duration of
           Pegasys® therapy post-treatment durability or accumulation of HBeAg seroconversion/HBsAg
           loss, preventable effect on long-term disease progression to liver cirrhosis and liver
           cancer. In addition, this study aims to collect more data on the efficacy and safety in
           a real-life clinical setting of Pegasys® therapy in patients with CHB.
    

Intervention name(s): pegylated Interferon-alpha 2a
Intervention type(s): Drug
Intervention description(s): Pegasys 180mcg/PFS/ subcutaneous injection / Once a week
Other intervention name(s): Pegasys
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        HBeAg-positive and HBeAg-negative chronic hepatitis B patients who have completed or are
        currently on Pegasys® monotherapy as a first line therapy. In addition, all consecutive CHB
        patients who will be initiated on Pegasys® in 2011 will be prospectively enrolled.
      
Keywords: Chronic hepatitis B; pegylated Interferon-alpha 2a; Korean