caa a22 4500 475818636 CHVBK 20180406123816.0 cr unu---uuuuu 170329e20000701xx s 000 0 eng 10.1007/s002280000148 doi (NATIONALLICENCE)springer-10.1007/s002280000148 A study of the pharmacokinetic interaction between lamivudine and alpha interferon [Elektronische Daten] [M. A. Johnson, J. M. Jenkins, C. Bye] Objective: This study was designed to investigate any possible pharmacokinetic interaction between lamivudine and alpha interferon as potential candidates for combination therapy for the treatment of hepatitis B virus (HBV). Methods: Nineteen healthy male, Caucasian volunteers, aged 20-41 years and weighing 60.5-83.5 kg completed this open, non-randomised study. They each received a single, abdominal, deep s.c. injection of 10 mIU alpha interferon on day 1, followed by a wash-out period of at least 1 week. Subjects then began a 7-day course of lamivudine (100 mg) followed by a further 10-mIU alpha-interferon injection directly after oral lamivudine dosing. Blood and urine samples were taken pre- and post-dose for alpha-interferon and/or lamivudine assay. Results: Lamivudine was safe and well tolerated in all subjects. No adverse events were reported in subjects on lamivudine, whereas 106 adverse events considered attributable to alpha interferon were recorded. Statistical analysis of pharmacokinetic parameters indicated no significant effect of lamivudine on alpha-interferon pharmacokinetics. There was a small statistically significant reduction (∼10%) in the area under the lamivudine concentration-time curve on co-administration with alpha interferon and a concomitant increase in clearance, which is not considered clinically relevant. Conclusions: Alpha interferon and lamivudine can be co-administered with no requirement for dose modification, as there was no clinically significant difference in the pharmacokinetics of either drug. Springer-Verlag Berlin Heidelberg, 2000 Key words Lamivudine nationallicence Alpha interferon nationallicence Hepatitis B virus nationallicence Johnson M. A. Department of Clinical Pharmacology, GlaxoWellcome Incorporated, Research Triangle Park, North Carolina, 27709, USA e-mail: MAJ4852@glaxowellcome.com Tel.: +1-919-4836068, US aut Jenkins J. M. Clinical Pharmacology, Glaxo Wellcome R&D, Greenford, Middlesex, UK, GB aut Bye C. Clinical Pharmacology, Glaxo Wellcome R&D, Greenford, Middlesex, UK, GB aut https://doi.org/10.1007/s002280000148 text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/s002280000148 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Johnson M. A. Department of Clinical Pharmacology, GlaxoWellcome Incorporated, Research Triangle Park, North Carolina, 27709, USA e-mail: MAJ4852@glaxowellcome.com Tel.: +1-919-4836068, US aut NATIONALLICENCE 700 1- Jenkins J. M. Clinical Pharmacology, Glaxo Wellcome R&D, Greenford, Middlesex, UK, GB aut NATIONALLICENCE 700 1- Bye C. Clinical Pharmacology, Glaxo Wellcome R&D, Greenford, Middlesex, UK, GB aut Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer