Chronic Hepatitis B Clinical Trial
Official title:
The Optimizing Treatment of Peginterferon Alpha in Chronic Hepatitis B Patients With Low Level HBsAg(I-Cure-3X)
HBeAg-negative chronic hepatitis B (CHB) patients with low Level HBsAg were enrolled. After
giving informed consent, patients were treated with nucleoside analog(s) (NAs) once a day and
weekly subcutaneous injections of peginterferon alfa-2a 180 micrograms/week or peginterferon
alfa-2b 180 micrograms/week for 12 weeks. At week 12, the decrease of HBsAg was evaluated.
①If the decrease of HBsAg is more than 50% compared to baseline level. NAs was stopped,
patients were treated with weekly subcutaneous injections of alfa-2a 180 micrograms/week or
peginterferon alfa-2b 180 micrograms/week. Treatment endpoint was HBsAg loss(＜0.05 IU/ mL).
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 week 96.
After treatment, all patients were followed up for 48 weeks.
②If the decrease of HBsAg is less than 50% compared to baseline level. The combination
therapy of NAs and peginterferon alfa was extended to week 24. Then, the decrease of HBsAg
was evaluated again.
If the decrease of HBsAg is more than 50% compared to baseline level. NAs was stopped,
patients were treated with weekly subcutaneous injections of alfa-2a 180 micrograms/week or
peginterferon alfa-2b 180 micrograms/week. Treatment endpoint was HBsAg loss(＜0.05 IU/mL).
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 week 96.
After treatment, all patients were followed up for 48 weeks.
If the decrease of HBsAg is less than 50% compared to baseline level. Peginterferon alfa was
stopped, patients were treated with NAs once a day and then followed up for 48 weeks.
Patients who maintained the original NAs treatment served as a control group.
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 were enrolled in the out-patient
department of Third Affiliated Hospital of Sun Yat-sen University and Wuhan Union Hospital.
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 nucleoside analog(s) (NAs) once a day and weekly subcutaneous injections of
peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 180 micrograms/week for 12
weeks. At week 12, the decrease of HBsAg was evaluated.
①If the decrease of HBsAg is more than 50% compared to baseline level. NAs was stopped,
patients were treated with weekly subcutaneous injections of alfa-2a 180 micrograms/week or
peginterferon alfa-2b 180 micrograms/week. Treatment endpoint was HBsAg loss(＜0.05 IU/ mL).
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 week 96.
After treatment, all patients were followed up for 48 weeks.
②If the decrease of HBsAg is less than 50% compared to baseline level. The combination
therapy of NAs and peginterferon alfa was extended to week 24. Then, the decrease of HBsAg
was evaluated again.
If the decrease of HBsAg is more than 50% compared to baseline level. NAs was stopped,
patients were treated with weekly subcutaneous injections of alfa-2a 180 micrograms/week or
peginterferon alfa-2b 180 micrograms/week. Treatment endpoint was HBsAg loss(＜0.05 IU/mL).
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 week 96.
After treatment, all patients were followed up for 48 weeks.
If the decrease of HBsAg is less than 50% compared to baseline level. Peginterferon alfa was
stopped, patients were treated with NAs once a day and then followed up for 48 weeks.
The use of other immune suppressive or regulatory drugs and other antiviral drugs was
prohibited during the course of the study. In this study, HBsAg loss(＜0.05 IU/mL) was defined
as treatment endpoint. Anti-HBs positive(＞10 milli-International unit)(mIU/mL) was defined as
seroconversion.
Patients who maintained the original NAs treatment served as a control group.
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