Functional Cure of Hepatitis B in HIV/HBV Co-infected Patients

Study Overview
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Brief Summary
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Evaluate the potential of ART combined with interferon therapy to achieve functional cure of hepatitis B in HIV/HBV co-infected patients

Detailed Description
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This is a prospective, non-randomized, clinical observational cohort study. The subjects are the advantageous population for functional cure of hepatitis B in HIV/HBV co-infected patients . Depending on whether interferon therapy is used in the real world , the patients are divided into two groups: the ART combined with interferon group and the ART alone group, with 30 cases in each group. Hepatitis B surface antigen seroclearance rate and seroconversion rate will be observed during the study period.

Official Title
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A Clinical Research on Functional Cure Strategies for Hepatitis B Among HIV/HBV Co-infected Patients in China

Conditions
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AIDS, Hepatitis B

Intervention / Treatment
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* Drug: Peginterferon alfa-2b Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-65 years old, gender unrestricted. Meeting the People's Republic of China Health Industry Standard (WS293-2008) - AIDS and HIV Infection Diagnostic Criteria, confirmed as HIV-1 infected. HBsAg positive for more than 6 months. At least 1 year of ART treatment prior to screening, and currently undergoing ART treatment with HBsAg <1000IU/mL, HBeAg negative, HBV DNA <100IU/ml, CD4+T lymphocyte count >200 cells/μL and HIV-RNA<20 copies/ml. Exclusion Criteria: Pregnant, nursing, planning pregnancy, or with severe mental disorders or uncontrolled epilepsy. Co-infected with Hepatitis A, C, D, or E viruses. With other chronic liver diseases like autoimmune hepatitis, drug-induced hepatitis, alcoholic hepatitis, genetic metabolic liver diseases, or moderate to severe fatty liver. With autoimmune diseases like rheumatoid arthritis, psoriasis, or lupus. Post organ transplant, planning organ transplant, diagnosed or suspected of liver cancer or other malignant tumors, or undergoing immunosuppressive treatment. With severe diseases of heart, lungs, kidneys, brain, retinal disorders, or uncontrolled hypertension or diabetes. Excessive alcohol (average daily alcohol intake >40g for men, >20g for women) or drug users. Participated in other interventional trials within the last three months, or other situations deemed inappropriate for inclusion by researchers.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ART combined with interferon group<br>The treatment protocol is ART combined with pegylated interferon α-2b injection. The pegylated interferon α-2b injection is administered subcutaneously at a dose of 180ug once a week. Follow-up times are at baseline, and during treatment at weeks 4, 8, 12, 24, 36, 48, 60, and 72. | Drug: Peginterferon alfa-2b Injection<br>* The pegylated interferon α-2b injection is administered subcutaneously at a dose of 180ug once a week.<br>|
| ART group<br>Continuously using ART treatment, without the use of interferon. Follow-up times are at baseline, and during treatment at weeks 12, 24, 36, 48, 60, and 72. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatitis B surface antigen seroclearance | Hepatitis B surface antigen quantification less than 0.05 IU/mL. | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatitis B surface antigen seroconversion | Clearance of surface antigen concurrently accompanied by the production of surface antibodies | 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV/HBV co-infection, Functional cure, Interferon