title: Combination therapy with pegylated interferon alpha-2b and adefovir dipivoxil in HBeAg-positive chronic hepatitis B versus interferon alone: a prospective, randomized study.
abstract: Currently available monotherapies of oral nucleoside/nucleotide analogs or interferon are unable to achieve a sustained and effective response in most of patients with chronic hepatitis B (CHB). The objective of the present study was to compare the efficacy and safety of pegylated interferon (Peg-IFN) alpha-2b plus adefovir dipivoxil combination therapy versus Peg-IFN alpha-2b alone. Sixty-one HBeAg-positive chronic hepatitis B patients were randomized to receive Peg-IFN alpha-2b alone (1.5 μg/kg once weekly) or Peg-IFN alpha-2b plus adefovir (10 mg daily) for up to 52 weeks. Efficacy and safety analyses were performed on all participants who received at least one dose of study medication. The rate of HBeAg seroconversion and undetectable HBV-DNA were evaluated after 52 weeks of therapy. At the end of treatment, 11 of 30 (36.7%) patients receiving combination therapy achieved HBeAg seroconversion versus 8 of 31 (25.8%) in the monotherapy group (P=0.36). In contrast, the percentage of patients with undetectable serum HBV DNA was significantly higher in the combination group than in the monotherapy group (76.7% vs. 29.0%, P<0.001). Thyroid dysfunction was more frequent in the combination group than in the monotherapy group (P<0.05). In HBeAg-positive CHB, combination of Peg-IFN alpha-2b and adefovir for 52 weeks resulted, at the end of treatment, in a higher virological response but without significant impact on the rate of HBeAg seroconversion and possibly an adverse effect on thyroid function.
authors.affiliation: Department of Infectious Diseases, the First Affiliated Hospital of Shantou University Medical College, Shantou, 515041, China.
authors.forename: Yu-Hua
authors.initials: YH
authors.lastname: Liu
authors.affiliation: Department of Infectious Diseases, the First Affiliated Hospital of Shantou University Medical College, Shantou, 515041, China.
authors.forename: Tao
authors.initials: T
authors.lastname: Wu
authors.affiliation: Department of Infectious Diseases, the First Affiliated Hospital of Shantou University Medical College, Shantou, 515041, China.
authors.forename: Ning
authors.initials: N
authors.lastname: Sun
authors.affiliation: Department of Infectious Diseases, the First Affiliated Hospital of Shantou University Medical College, Shantou, 515041, China.
authors.forename: Guang-Li
authors.initials: GL
authors.lastname: Wang
authors.affiliation: Department of Infectious Diseases, the First Affiliated Hospital of Shantou University Medical College, Shantou, 515041, China.
authors.forename: Jian-Zhi
authors.initials: JZ
authors.lastname: Yuan
authors.affiliation: Department of Infectious Diseases, the First Affiliated Hospital of Shantou University Medical College, Shantou, 515041, China.
authors.forename: Yu-Rong
authors.initials: YR
authors.lastname: Dai
authors.affiliation: Department of Infectious Diseases, the First Affiliated Hospital of Shantou University Medical College, Shantou, 515041, China. southernice@126.com.
authors.forename: Xiao-Hui
authors.initials: XH
authors.lastname: Zhou
mesh_terms: D000225:Adenine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000293:Adolescent; D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004359:Drug Therapy, Combination; D005260:Female; D006513:Hepatitis B e Antigens / Q000097:blood*; D019694:Hepatitis B, Chronic / Q000097:blood* / Q000188:drug therapy*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D063065:Organophosphonates / Q000008:administration & dosage* / Q000009:adverse effects; D011092:Polyethylene Glycols / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D000998:Antiviral Agents; D006513:Hepatitis B e Antigens; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D063065:Organophosphonates; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; C053001:adefovir; C417083:peginterferon alfa-2b; D000225:Adenine