Chronic Hepatitis B Clinical Trial
Official title:
An Observational, Multi-Center, Cohort Study Evaluating the Antiviral Efficacy, Safety, and Tolerability in Korean Patients With Chronic Hepatitis B (CHB) Receiving Pegylated Interferon-alpha 2a (Pegasys®): TRACES STUDY
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.
- 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.
;
Observational Model: Cohort, Time Perspective: Prospective
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