Randomized, controlled pharmacokinetic and pharmacodynamic evaluation of albinterferon in patients with chronic hepatitis B infection
Journal
Journal of Gastroenterology and Hepatology (Australia)
Journal Volume
30
Journal Issue
1
Pages
184-191
Date Issued
2015
Author(s)
Colvin R.A.
Tanwandee T.
Piratvisuth T.
Thongsawat S.
Hui A.J.
Zhang H.
Ren H.
Chuang W.-L.
Sobhonslidsuk A.
Li R.
Qi Y.
Praestgaard J.
Han Y.
Xu J.
Stein D.S.
Chien R.-N.
Flisiak R.
Jablkowski M.
Liaw Y.-F.
Sung J.J.-Y.
Abstract
Background and Aims: 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 1200μg 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). ? 2014 Journal of Gastroenterology and Hepatology Foundation and Wiley Publishing Asia Pty Ltd.
Subjects
Albinterferon; Hepatitis B; Lung diffusion capacity
SDGs
Other Subjects
peginterferon alpha2a; alanine aminotransferase; albinterferon alpha2b; albuminoid; alpha interferon; antivirus agent; biological marker; hepatitis B(e) antigen; macrogol derivative; peginterferon alpha2a; recombinant protein; virus DNA; adult; aged; alanine aminotransferase blood level; Article; drug safety; drug tolerability; female; flu like syndrome; follow up; good clinical practice; hepatitis B; human; limit of detection; lung diffusion capacity; lung function; major clinical study; male; polymerase chain reaction; post hoc analysis; priority journal; risk assessment; blood; clinical trial; comparative study; controlled study; genetics; Hepatitis B virus; Hepatitis B, Chronic; immunology; multicenter study; randomized controlled trial; treatment outcome; virology; young adult; Adult; Alanine Transaminase; Albumins; Antiviral Agents; Biological Markers; DNA, Viral; Female; Hepatitis B e Antigens; Hepatitis B virus; Hepatitis B, Chronic; Humans; Interferon-alpha; Male; Polyethylene Glycols; Recombinant Proteins; Treatment Outcome; Young Adult
Publisher
Blackwell Publishing
Type
journal article