Efficacy and Safety of Antiviral Therapy With Peg-interferon for Chronic Hepatitis B Complicated With Nonalcoholic Fatty Liver Disease（OCEAN PROJECT）

Más betegség

• co-infection with active hepatitis A, C, D, E and/or HIV; Or combined with drug-induced liver injury, inherited metabolic liver disease, autoimmune hepatitis, alcoholic liver disease;
• The patients and their close relatives (parents, siblings, etc.) had a history of severe mental illness, especially depression. Severe psychosis is defined as severe depression or psychosis, suicide attempt, hospitalization due to psychosis, or a period of incapacitation due to psychosis;
• patients with a history of immune-mediated diseases (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis) or abnormally elevated levels of autoimmune antibodies;
• patients with serious diseases of heart, lung, kidney, brain, blood and other important organs, and patients with other malignant tumors;
• history of severe epilepsy or current use of antiepileptic drugs. Control of unstable diabetes, hypertension, thyroid disease, etc. A history of severe retinopathy or other evidence of retinopathy;
• any history of organ transplantation and existing functional graft (except corneal or hair transplantation);
• patients who are allergic to interferon and its drug components, and who are not suitable for interferon according to the investigator's judgment;

Laborértékek

• patients diagnosed with hepatitis B cirrhosis, that is, those with liver biopsy pathology consistent with liver cirrhosis, or with two or more of the following five criteria, excluding non-cirrhotic portal hypertension: ① imaging examination showed signs of liver cirrhosis and/or portal hypertension; ② Esophagogastric varices were found by endoscopy; ③ Liver stiffness was consistent with cirrhosis; ④ Blood biochemical examination showed decreased albumin level (< 35 g/L) and/or prolonged prothrombin time (prolonged > 3 seconds compared with the control); ⑤ Blood routine examination showed platelet count < 100×109/L;
• neutrophil count <1.5×109/L or platelet count <90×109/L. Patients with creatinine higher than 1.5 times the upper limit of normal;

Egyéb

• Liver tumor was detected by liver imaging at the time of screening;
• pregnant or lactating women or those who plan to become pregnant and do not want to use contraception during the study period;
• Patients deemed by the investigator to be ineligible for the study.

• Age of 18-60 years old, male or female (including 18 and 60 years old);
• meet the diagnostic criteria for chronic hepatitis B in the Guidelines for the prevention and treatment of chronic hepatitis B (2022 edition), and meet the imaging diagnostic criteria for fatty liver in the guidelines for the prevention and treatment of non-alcoholic fatty liver disease (2018 Update edition).
• serum HBsAg positive >6 months;
• NAs treatment: baseline HBsAg≤1500 IU/ml, HBeAg negative, HBV DNA negative (not detected);
• IHC initial treatment: baseline HBsAg<1000 IU/ml, HBeAg negative, HBV DNA negative (undetectable), ALT and AST persistently normal (ULN: <50 IU/L in men, <40 IU/L in women);
• a negative serum pregnancy test within 24 hours before the first dose (for women of reproductive age);
• willing to receive treatment and signed informed consent.