Randomized, controlled pharmacokinetic and pharmacodynamic evaluation of albinterferon in patients with chronic hepatitis B infection

Richard A. Colvin*, Tawesak Tanwandee, Teerha Piratvisuth, Satawat Thongsawat, Aric Josun Hui, Hongfei Zhang, Hong Ren, Pei Jer Chen, Wan Long Chuang, Abhasnee Sobhonslidsuk, Ruobing Li, Yin Qi, Jens Praestgaard, Yi Han, Junfang Xu, Daniel S. Stein, Rong Nan Chien, Robert Flisiak, Maciej Jablkowski, Yun Fan LiawJoseph Jao Yiu Sung

*Corresponding author for this work

Research output: Contribution to journalJournal Article peer-review

6 Scopus citations

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).

Original languageEnglish
Pages (from-to)184-191
Number of pages8
JournalJournal of Gastroenterology and Hepatology (Australia)
Volume30
Issue number1
DOIs
StatePublished - 01 01 2015

Bibliographical note

Publisher Copyright:
© 2014 Journal of Gastroenterology and Hepatology Foundation and Wiley Publishing Asia Pty Ltd.

Keywords

  • Albinterferon
  • Hepatitis B
  • Lung diffusion capacity

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