title: Randomized, controlled pharmacokinetic and pharmacodynamic evaluation of albinterferon in patients with chronic hepatitis B infection.
abstract: OBJECTIVE
  Albinterferon is a fusion of albumin and interferon-α2b developed to improve the pharmacokinetics, convenience, and potential efficacy of interferon-α for the treatment of chronic hepatitis infections.
  
  
  METHODS
  This open-label, randomized, active-controlled, multicenter study investigated the safety and efficacy of albinterferon in patients with chronic hepatitis B virus (HBV) infection who were e-antigen (HBeAg) positive. One hundred and forty-one patients received one of four albinterferon doses/regimens or pegylated-interferon-α2a. Primary efficacy outcomes were changes in serum HBeAg and antibody, HBV-DNA, and alanine aminotransferase. Principal safety outcomes were changes in laboratory values, pulmonary function, and adverse events.
  
  
  RESULTS
  The study was prematurely terminated as phase III trials in hepatitis C infection indicated noninferior efficacy but inferior safety compared with pegylated-interferon-α2a. Here, all treatment groups had a significant reduction in HBV-DNA from baseline. Reductions in HBV-DNA were not significantly different, except the 1200 μg every 4 weeks albinterferon dose which was inferior compared with pegylated-interferon-α2a. The serum alanine aminotransferase levels decreased in all arms. The per-patient incidence of adverse events was not significantly different for albinterferon (96.4-100%) and pegylated-interferon-α2a (93.1%). Total adverse events, however, were higher for albinterferon and correlated to dose. Decreased lung function was found in all arms (∼93% of patients), and was more common in some albinterferon groups.
  
  
  CONCLUSIONS
  Albinterferon doses with similar anti-HBV efficacy to pegylated-interferon-α2a had higher rates of certain adverse events, particularly changes in lung diffusion capacity (http://www.clinicaltrials.gov number NCT00964665).
authors.affiliation: Novartis Institutes for BioMedical Research, Cambridge, Massachusetts, USA.
authors.forename: Richard A
authors.initials: RA
authors.lastname: Colvin
authors.forename: Tawesak
authors.initials: T
authors.lastname: Tanwandee
authors.forename: Teerha
authors.initials: T
authors.lastname: Piratvisuth
authors.forename: Satawat
authors.initials: S
authors.lastname: Thongsawat
authors.forename: Aric Josun
authors.initials: AJ
authors.lastname: Hui
authors.forename: Hongfei
authors.initials: H
authors.lastname: Zhang
authors.forename: Hong
authors.initials: H
authors.lastname: Ren
authors.forename: Pei-Jer
authors.initials: PJ
authors.lastname: Chen
authors.forename: Wan-Long
authors.initials: WL
authors.lastname: Chuang
authors.forename: Abhasnee
authors.initials: A
authors.lastname: Sobhonslidsuk
authors.forename: Ruobing
authors.initials: R
authors.lastname: Li
authors.forename: Yin
authors.initials: Y
authors.lastname: Qi
authors.forename: Jens
authors.initials: J
authors.lastname: Praestgaard
authors.forename: Yi
authors.initials: Y
authors.lastname: Han
authors.forename: Junfang
authors.initials: J
authors.lastname: Xu
authors.forename: Daniel S
authors.initials: DS
authors.lastname: Stein
mesh_terms: D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D000418:Albumins / Q000008:administration & dosage* / Q000009:adverse effects; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects; D015415:Biomarkers / Q000097:blood; D004279:DNA, Viral / Q000097:blood; D005260:Female; D006513:Hepatitis B e Antigens / Q000097:blood; D006515:Hepatitis B virus / Q000235:genetics / Q000276:immunology; D019694:Hepatitis B, Chronic / Q000175:diagnosis / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000009:adverse effects; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000418:Albumins; D000998:Antiviral Agents; D015415:Biomarkers; D004279:DNA, Viral; D006513:Hepatitis B e Antigens; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; C531108:albinterferon alfa-2b; D000410:Alanine Transaminase; C100416:peginterferon alfa-2a
keywords: albinterferon; hepatitis B; lung diffusion capacity