Optimization of Antiviral Therapy of Chronic HBV Infection

Naval Military Medical University

Status

Completed

Conditions

Adverse Effects

Hepatitis B

Australia Antigen Positive

Treatments

Drug: Interferon Alfa-2a add on ADV

Study type

Observational

Funder types

Other

Identifiers

NCT01623778

HBV2012

Details and patient eligibility

About

Along with the improvement of the accuracy of detection of HBV serological markers, the optimization of antiviral therapy for patients with chronic hepatitis B (CHB) infection becomes feasible. Currently, the recommendation of optimized treatment especially interferon therapy are mainly based on retrospective studies, it still lacks prospective evidence. This study is aimed to evaluate the efficacy, safety and pharmacoeconomics benefits of 48 weeks optimized interferon therapy (switch to telbivudine or plus adefovir dipivoxil) for HBeAg positive CHB with inadequate response to 24 weeks interferon treatment.

Full description

Patients with inadequate response to interferon therapy at 24 weeks were enrolled in this study and accepted the optimized therapy (add on ADV or switch to LDT) for 48weeks. All these patients were followed for 48 weeks and the HBeAg seroconversion and HBV DNA level were observed. Safety and the economic effect of the two optimized therapy methods also were observed.

Enrollment

67 patients

Sex

All

Ages

16 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

patients receiving Peg interferon α-2a with inadequate response at 24 weeks (HBeAg titer ≥ 100Paul Ehrlich Institute Unit (PEIU)/ml and HBV DNA ≥ 5.0 Log copies/ml or HBV DNA titer decline <1 Log copies/ml) were enrolled into this study.

Exclusion criteria

no decompensated cirrhosis,
no hepatitis C, hepatitis D or human immunodeficiency virus (HIV) co-infection,
no hepatocellular carcinoma and other tumors or history of severe hepatitis,
no other systems diseases, such as a history of cardiopulmonary diseases, thyroid disorders, immune system disorders, epilepsy or mental illness (such as severe depression).