tetano
Editor, Senior Moderator
Clin Drug Investig. 2018 Sep 10. doi: 10.1007/s40261-018-0697-2. [Epub ahead of print]
[h=1]Evaluation of Drug-Drug Interaction Potential between Baloxavir Marboxil and Oseltamivir in Healthy Subjects.[/h] Kawaguchi N[SUP]1[/SUP], Koshimichi H[SUP]1[/SUP], Ishibashi T[SUP]2[/SUP], Wajima T[SUP]1[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND AND OBJECTIVE:[/h] Baloxavir marboxil is a prodrug that is metabolized to baloxavir acid, which suppresses viral replication by inhibiting cap-dependent endonuclease with a single oral administration. As the mode of action of baloxavir marboxil is different from that of neuraminidase inhibitors, such as oseltamivir, combination treatment with these drugs can be a treatment option, particularly for severe influenza infection. The aim of this study was to assess the drug-drug interaction between baloxavir marboxil and oseltamivir.
[h=4]METHODS:[/h] Eighteen healthy adult subjects received three treatments in a crossover fashion: single administration of baloxavir marboxil 40 mg alone, repeated twice-daily administration of oseltamivir at 75 mg for 5 days, or single administration of baloxavir marboxil at 40 mg in combination with repeated twice-daily administration of oseltamivir at 75 mg for 5 days.
[h=4]RESULTS:[/h] The ratios (90% confidence intervals) of maximum plasma concentration and area under the plasma concentration-time curve of baloxavir acid after co-administration compared to baloxavir marboxil alone were 1.03 (0.92-1.15) and 1.01 (0.96-1.06), respectively. The ratios (90% confidence intervals) of maximum plasma concentration and area under the plasma concentration-time curve of oseltamivir carboxylate, the active form of oseltamivir, after co-administration compared to oseltamivir alone were 0.96 (0.93-1.00) and 0.99 (0.96-1.01), respectively, at steady state on day 5. Treatment-emergent adverse events reported were mild and not considered to be related to the study drug.
[h=4]CONCLUSION:[/h] The lack of a clinically meaningful drug-drug interaction between baloxavir marboxil and oseltamivir has been established.
PMID: 30203386 DOI: 10.1007/s40261-018-0697-2
[h=1]Evaluation of Drug-Drug Interaction Potential between Baloxavir Marboxil and Oseltamivir in Healthy Subjects.[/h] Kawaguchi N[SUP]1[/SUP], Koshimichi H[SUP]1[/SUP], Ishibashi T[SUP]2[/SUP], Wajima T[SUP]1[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND AND OBJECTIVE:[/h] Baloxavir marboxil is a prodrug that is metabolized to baloxavir acid, which suppresses viral replication by inhibiting cap-dependent endonuclease with a single oral administration. As the mode of action of baloxavir marboxil is different from that of neuraminidase inhibitors, such as oseltamivir, combination treatment with these drugs can be a treatment option, particularly for severe influenza infection. The aim of this study was to assess the drug-drug interaction between baloxavir marboxil and oseltamivir.
[h=4]METHODS:[/h] Eighteen healthy adult subjects received three treatments in a crossover fashion: single administration of baloxavir marboxil 40 mg alone, repeated twice-daily administration of oseltamivir at 75 mg for 5 days, or single administration of baloxavir marboxil at 40 mg in combination with repeated twice-daily administration of oseltamivir at 75 mg for 5 days.
[h=4]RESULTS:[/h] The ratios (90% confidence intervals) of maximum plasma concentration and area under the plasma concentration-time curve of baloxavir acid after co-administration compared to baloxavir marboxil alone were 1.03 (0.92-1.15) and 1.01 (0.96-1.06), respectively. The ratios (90% confidence intervals) of maximum plasma concentration and area under the plasma concentration-time curve of oseltamivir carboxylate, the active form of oseltamivir, after co-administration compared to oseltamivir alone were 0.96 (0.93-1.00) and 0.99 (0.96-1.01), respectively, at steady state on day 5. Treatment-emergent adverse events reported were mild and not considered to be related to the study drug.
[h=4]CONCLUSION:[/h] The lack of a clinically meaningful drug-drug interaction between baloxavir marboxil and oseltamivir has been established.
PMID: 30203386 DOI: 10.1007/s40261-018-0697-2