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

Sponsor

Guangzhou 8th People's Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05988879

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
AIDS Hepatitis B	Drug: Peginterferon alfa-2b Injection

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 Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 2, 2023

Anticipated Primary Completion Date :

Aug 2, 2026

Anticipated Study Completion Date :

Aug 2, 2028

Arms and Interventions

Arm	Intervention/Treatment
ART combined with interferon group 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 The pegylated interferon α-2b injection is administered subcutaneously at a dose of 180ug once a week.
ART group 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.

Arm

Intervention/Treatment

ART combined with interferon group

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

The pegylated interferon α-2b injection is administered subcutaneously at a dose of 180ug once a week.

ART group

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.

Outcome Measures

Primary Outcome Measures

Hepatitis B surface antigen seroclearance [48 weeks]
Hepatitis B surface antigen quantification less than 0.05 IU/mL.

Secondary Outcome Measures

Hepatitis B surface antigen seroconversion [48 weeks]
Clearance of surface antigen concurrently accompanied by the production of surface antibodies

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.