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

Recruiting

• Conditions: AIDS; Hepatitis B
• Interventions: Drug: Peginterferon alfa-2b Injection

• Registration Number: NCT05988879
• Lead Sponsor: Guangzhou 8th People's Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Status Verified: 2023-08
• Study Start: 2023-08-02
• Study First Submitted: 2023-08-03
• Study First Submitted QC: 2023-08-03
• Last Update Submitted: 2023-08-10
• Study First Posted: 2023-08-14
• Last Update Posted: 2023-08-14
• Primary Completion: 2026-08-02
• Study Completion: 2028-08-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Age 18-65 years old, gender unrestricted.
2. Meeting the People's Republic of China Health Industry Standard (WS293-2008) - "AIDS and HIV Infection Diagnostic Criteria", confirmed as HIV-1 infected.
3. HBsAg positive for more than 6 months.
4. 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

1. Pregnant, nursing, planning pregnancy, or with severe mental disorders or uncontrolled epilepsy.
2. Co-infected with Hepatitis A, C, D, or E viruses.
3. With other chronic liver diseases like autoimmune hepatitis, drug-induced hepatitis, alcoholic hepatitis, genetic metabolic liver diseases, or moderate to severe fatty liver.
4. With autoimmune diseases like rheumatoid arthritis, psoriasis, or lupus.
5. Post organ transplant, planning organ transplant, diagnosed or suspected of liver cancer or other malignant tumors, or undergoing immunosuppressive treatment.
6. With severe diseases of heart, lungs, kidneys, brain, retinal disorders, or uncontrolled hypertension or diabetes.
7. Excessive alcohol (average daily alcohol intake >40g for men, >20g for women) or drug users.
8. Participated in other interventional trials within the last three months, or other situations deemed inappropriate for inclusion by researchers.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ART combined with interferon group	Peginterferon alfa-2b Injection	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.

Primary Outcome Measures

Name	Time	Method
Hepatitis B surface antigen seroclearance	48 weeks	Hepatitis B surface antigen quantification less than 0.05 IU/mL.

Secondary Outcome Measures

Name	Time	Method
Hepatitis B surface antigen seroconversion	48 weeks	Clearance of surface antigen concurrently accompanied by the production of surface antibodies

Trial Locations

Locations (1)

Guangzhou Eighth People's Hospital, Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China