Previous studies have shown that there are alterations in the number and affinity of interferon receptors during interferon therapy and that such alterations recover to varying degrees some time after the end of treatment. It can be conjectured that the rest period of pulsed therapy facilitates the recovery of type I interferon receptors and thus the next round of IFN therapy compared to a continuous regimen of interferon.
Age 18 to 60 years, both sexes (both 18 and 60 years)
HBsAg positive for more than 6 months;
NAs treated patients on continuous NA therapy for more than 6 months with HBsAg ≥ 1500 IU/ml and HBV-DNA < 500 IU/ml at enrolment;
Primary treated patients with surface antigen >1500 IU, unlimited E antigen and unlimited HBV DNA at enrolment, meeting the treatment indications of the 2019 edition of the guidelines for the prevention and treatment of chronic hepatitis B.
Combined active hepatitis A, C, D, E and/or HIV infection;
Patients who are on future and intend to continue to use tibivudine
methaemoglobin greater than 100ng/ml at screening; or methaemoglobin that has not remained stable for 3 months prior to the trial and/or liver imaging suggestive of liver tumours;
decompensated liver disease (Child-Pugh score ≥ 7), meaning that patients will be excluded if one of the following is met: prolonged prothrombin time ≥ 3 seconds, serum bilirubin > 34umol/L, history of hepatic encephalopathy, history of oesophageal variceal bleeding, ascites;
Anhui Medical University
Lead sponsor
The First Affiliated Hospital, University of Science and Technology of China
Collaborator
The Second Hospital of Anhui Medical University
Collaborator
Chaohu Hospital of Anhui Medical University
Collaborator
The First Affiliated Hospital of Bengbu Medical University
Collaborator