Key result
Simultaneous administration of cobicistat with dabigatran resulted in a 127% increase in both the geometric mean area-under-the-concentration-versus-time curve and maximal concentration (P<0.001).
Why the study?
Does cobicistat increase the pharmacokinetic exposure and anticoagulant effect of dabigatran in healthy HIV-negative volunteers?
Does cobicistat increase the pharmacokinetic exposure and anticoagulant effect of dabigatran in healthy HIV-negative volunteers?
Effect estimate: 127% increase
p-value: p=<0.001
Simultaneous administration of the antiretroviral boosting agent cobicistat significantly increases dabigatran exposure, highlighting a clinically relevant drug-drug interaction.
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Cobicistat coadministration with dabigatran warrants avoidance or monitoring; extends pharmacokinetic interaction data to boosted antiretrovirals.
Gordon et al. (2016) studied Healthy HIV-negative volunteers (n=18). Cobicistat vs. Dabigatran alone was evaluated on Dabigatran pharmacokinetic exposure (geometric mean area-under-the-concentration-versus-time curve from time zero to infinity and maximal concentration) (127% increase, p=<0.001). Simultaneous administration of cobicistat with dabigatran resulted in a 127% increase in both the geometric mean area-under-the-concentration-versus-time curve and maximal concentration (P<0.001).
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