*The concomitant use of DCV-TRIO (DCV 30 mg, ASV 200 mg, BCV 75 mg twice daily) and SER resulted in significantly reduced exposure and plasma concentrations of SER. Therefore, monitoring for changes in depressive symptoms is warranted when this combination is utilized, and up-titration of SER 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.
Daclatasvir/asunaprevir/beclabuvir vs sertraline or escitalopram
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Study Design
In an open-label, single-sequence, 2-way study, 23 healthy subjects (n=23; 15 male, 8 female) received sertraline (SER) 50 mg once daily for 7 days (Days 1 -7). Following a 5-day washout (Days 8-12), subjects received DCV-TRIO, a fixed-dose regimen of daclatasvir (DCV) 30 mg, asunaprevir (ASV) 200 mg, and beclabuvir (BCV) 75 mg twice daily, plus an additional BCV 75mg BID for 10 days (Days 13-22). Subjects then received DCV-TRIO (+ BCV 75mg BID) with SER 50 mg once daily for 7 days (Days 23-29).
Study Results
The geometric mean ratios (GMRs; DCV-TRIO + SER / SER) [90% CIs] of SER were: 0.68 [0.65, 0.71] for Cmax, 0.62 [0.60, 0.65] for AUC, and 0.58 [0.55, 0.62] for C24.GMRs (DCV-TRIO + SER / DCV-TRIO) [90% CIs] of BCV were: 1.08 [1.01, 1.16] for Cmax, 0.94 [0.92, 0.97] for AUC, and 0.82 [0.76, 0.87] for C12.
References
X Tao, K Sims, M Hesney, et al. The effect of daclatasvir, asunaprevir, and beclabuvir on the pharmacokinetics of selective serotonin reuptake inhibitors in healthy subjects. 16th International Workshop On Clinical Pharmacology Of Hiv And Hepatitis Therapy. . ; 2015.
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