Peginterferon Treatment Study for Inactive Chronic Hepatitis B Patients
Status:
Recruiting
Trial end date:
2029-11-30
Target enrollment:
Participant gender:
Summary
There are about 400 million chronic hepatitis B virus (HBV) infection patients worldwide,
posing a serious threat to global public health security. In China, HBV infection occured
mainly in the perinatal period or infants, and about 10% of patients in the immune tolerance
stage spontaneously transit to the immune clearance stage every year and become
HBeAg-negative chronic HBV infection, resulting in a significant increase in the number of
inactive chronic hepatitis B (CHB) patients.
In recent years, different guidelines have not reached consensus on the need to initiate
antiviral therapy for inactive CHB patients: In the guidelines of Asian Pacific Association
for The Study of Liver(APASL)-2015 and American Association for the Study of Liver
Diseases(AASLD)-2018, antiviral therapy is generally not recommended for this group of
patients, and regular outpatient follow-up is recommended. Guideline of European Association
for the Study of the Liver(EASL)-2017 suggests that people with a family history of cirrhosis
and liver cancer at this stage could be treated with antiviral therapy even if they did not
meet the indications of antiviral therapy. According to Guidelines for the Prevention and
Treatment of Chronic Hepatitis B (version 2019) of China, antiviral therapy is still
recommended for some patients with inactive HBsAg carrier status who are HBV DNA positive and
meet the treatment indications. Studies have shown that some patients in immune tolerance
stage may enter the immune clearance stage and have hepatitis flare. Patients of inactive CHB
have the potential to develop HBeAg-negative CHB, and studies of long-term follow-up in this
population have indicated the risk of hepatocellular carcinoma. With the popularization of
the concept of functional cure for chronic hepatitis B, more and more people with inactive
CHB have a strong desire for treatment. In recent years, several studies have demonstrated
that Pegylated-interferon therapy can achieve high functional cure rate in patients with
inactive CHB.
The purpose of this study is to establish a national multi-center, prospective real world
study to compare the efficacy of different antiviral treatment regimens for patients with
inactive CHB and seek for the factors of functional cure.