Chronic Hepatitis B Clinical Trial
Official title:
The Optimizing Treatment of Peginterferon Alpha in HBeAg-negative Chronic Hepatitis B Virus Patients With Low Level HBsAg
HBeAg-negative chronic hepatitis B (CHB) patients with low Level HBsAg and with a history of drug resistance or suboptimal/partial virological response were enrolled. After giving informed consent, patients were treated with nucleoside analog(s) (NAs) once a day and weekly subcutaneous injections of alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week for 12 weeks. 12 weeks later, NAs was stopped, patients were treated with weekly subcutaneous injections of alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week. Treatment endpoint was HBsAg loss(＜0.05 IU/mL).
It is estimated that more than 400 million people are infected with hepatitis B virus (HBV)
globally. HBeAg-negative CHB patients with low Level HBsAg and with a history of drug
resistance or suboptimal/partial virological response were enrolled in the out-patient
department of 3rd Affiliated Hospital of Sun Yat-sen University. All of them were HBsAg
positive and anti-HBs negative for more than 6 months with HBV DNA<100 IU/mL and HBsAg levels
<1000 IU/mL. All patients did not have other liver diseases and contraindications for
interferon therapy.
After giving informed consent, patients were treated with NAs once a day and weekly
subcutaneous injections of alfa-2a 180 micrograms/week or peginterferon alfa-2b 80
micrograms/week for 12 weeks. 12 weeks later, NAs was stopped, patients were treated with
weekly subcutaneous injections of alfa-2a 180 micrograms/week or peginterferon alfa-2b 80
micrograms/week. The use of other immune suppressive or regulatory drugs and other antiviral
drugs was prohibited during the course of the study.
In this study, treatment endpoint was HBsAg loss(＜0.05 IU/mL).Anti-HBs positive(＞10
milli-International unit)(mIU/mL) defined as seroconversion. Depending on the decline of
HBsAg level, treatment was either continued for a prolonged period (no more than 96 weeks)
until the endpoint was achieved, or terminated in case of nonresponse.
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