Efficacy and safety of peginterferon alfa-2a (40 kd) plus adefovir for 96 weeks in HBeAg-negative chronic hepatitis B patients.
- Author:
Zhen-huan CAO
1
;
Li-na MA
;
Ya-li LIU
;
Yi JIN
;
Zhi-min HE
;
Jun-feng LU
;
Yong-hong ZHANG
;
Xin-yue CHEN
Author Information
- Publication Type:Clinical Trial
- MeSH: Adenine; administration & dosage; analogs & derivatives; therapeutic use; Adult; Antiviral Agents; administration & dosage; therapeutic use; Drug Therapy, Combination; Female; Hepatitis B e Antigens; Hepatitis B, Chronic; drug therapy; Humans; Interferon-alpha; administration & dosage; therapeutic use; Male; Middle Aged; Organophosphonates; administration & dosage; therapeutic use; Polyethylene Glycols; administration & dosage; therapeutic use; Recombinant Proteins; administration & dosage; therapeutic use; Treatment Outcome
- From: Chinese Journal of Hepatology 2013;21(7):498-501
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVETo investigate the efficacy and safety of an extended course (96-week) of combination treatment with peginterferon alfa-2a (Peg-IFNa-2a; 40 kd] plus adefovir (ADV) for treating chronic hepatitis B (CHB) in Chinese patients with negativity for hepatitis B e antigen (HBeAg).
METHODSA total of 25 consecutive patients with HBeAg-negative CHB were administered Peg-IFNa-2a (135-180 mug/week) plus ADV (10 mg/day) for 96 weeks. All patients were followed-up for 24 weeks after treatment completion. Levels of hepatitis B virus (HBV) DNA and hepatitis B surface antigen (HbsAg) were measured by fluorescence quantitative polymerase chain reaction (FQ-PCR) and chemiluminescent microparticle immunoassay, respectively, at 12-week intervals throughout the treatment course and at the end-of-follow-up (week 120). Patients underwent serological analysis at 3-6 month intervals during treatment and follow-up to evaluate occurrence of adverse events; serological parameters included blood count, markers of liver, kidney and thyroid function, and levels of autoantibodies and creatine kinase.
RESULTSFor all patients, the 96-week course of Peg-IFNa-2a plus ADV reduced the level of HBV DNA below the detection threshold (less than 500 copies/ml by FQ-PCR). The overall rate of HBsAg seroconversion was 12% (3/25) at week 48, 28% (7/25) at week 96, and 32% (8/25) at week 120. The occurrences of adverse events were similar at week 48 and week 96.
CONCLUSIONThe extended-course Peg-IFNa-2a plus ADV combination therapy achieved a 100% virological response and better rates of HBsAg seroconversion than 48 weeks of therapy, without a decrease in safety.
