Final results depend on the dose of asunaprevir and the concomitant drugs used.
Asunaprevir versus Escitalopram
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Study Design
In a drug interaction study in healthy volunteers (n=15), fasted men and women received escitalopram (ESC) 10 mg once daily on days 1-7 and 25-31, and asunaprevir (ASV) 100 mg twice daily on days 15-31.1 Blood samples for pharmacokinetic (PK) analyses were collected over 24 hours on days 7 and 31 for ESC, and those for ASV were collected over 12 hours on days 24 and 31.
Study Results
The geometric mean ratios (GMRs; ASV + ESC / ESC) [90% CIs] of ESC were 0.97 [0.92, 1.02] for Cmax and 0.95 [0.91, 0.98] for AUC, while GMRs (ESC + ASV / ASV) [90% CIs] of ASV were 0.87 [0.65, 1.18] for Cmax and 0.92 [0.76, 1.12] for AUC. The magnitude of these change was not clinically relevant and co-administration of ASV and ESC was well tolerated.
Study Conclusions
The investigators concluded that no dose adjustment is required for either drug when ASV 100mg is administered with ESC 10mg. However, the concomitant use of the DCV-TRIO (DCV 30 mg, ASV 200 mg, BCV 75 mg twice daily) + BCV 75mg BID and ESC 10 mg once daily resulted in significantly reduced exposure and plasma concentrations of ESC.2 Therefore, monitoring for changes in depressive symptoms is warranted when this combination is utilized, and up-titration of ESC should be considered if appropriate. ** In this study DCV-TRIO was administered with additional BCV 75mg BID in order to achieve BCV exposures comparable to those seen in HCV-infected individuals.
References
Eley T, Garimella T, Li W, Bertz RJ. Asunaprevir: a review of preclinical and clinical pharmacokinetics and drug–drug interactions. Clinical Pharmacokinetics. 2015; 12: 1205-1222.
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