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

Exclusion Criteria

• •1. 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;
• •2. Liver tumor was detected by liver imaging at the time of screening;
• •3. 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;
• •4. pregnant or lactating women or those who plan to become pregnant and do not want to use contraception during the study period;
• •5. 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;
• •6. 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;
• •7. 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;
• •8. patients with serious diseases of heart, lung, kidney, brain, blood and other important organs, and patients with other malignant tumors;
• •9. 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;
• •10. any history of organ transplantation and existing functional graft (except corneal or hair transplantation);
• •11. patients who are allergic to interferon and its drug components, and who are not suitable for interferon according to the investigator's judgment;
• •12. Patients deemed by the investigator to be ineligible for the study.