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A pharmacokinetic and pharmacodynamic evaluation of albinterferon (ABF656) in patients with chronic hepatitis B, eAg+, infection

Colvin, Richard and Tanwandee, Tawesak and Piratvisuth, Teerha and Thongsawat, Satawat and Hui, Aric Josun and Zhang, Hongfei and Hong, Ren and Chen, Pei-Jer and Chuang, Wan-Long and Sobhonslidsuk, Abhasnee and Li, Ruobing and Yin, Qi and Praestgaard, Jens and Han, Yi and Xu, Junfang and Stein, Daniel (2015) A pharmacokinetic and pharmacodynamic evaluation of albinterferon (ABF656) in patients with chronic hepatitis B, eAg+, infection. Journal of gastroenterology and hepatology, 30 (1). pp. 184-191. ISSN 1440-1746

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 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).

Item Type: Article
Date Deposited: 29 Apr 2016 23:45
Last Modified: 29 Apr 2016 23:45
URI: https://oak.novartis.com/id/eprint/9331

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