Atazanavir/Cobicistat + Daclatasvir = Unknown or no reaction

Effect on Concentration

Applies within class?
No
Daclatasvir
No change
Applies within class?
No

Pharmacologic Effects

Effect
N/A
Applies within class?
No
Effect
N/A
Applies within class?
No

Interaction History

N/A

Last Updated 09-Jul-2018

Summary

The authors concluded that since ATV/r and ATV/c had similar effects on daclatasvir PK parameters, daclatasvir 30 mg daily can be utilized with atazanavir/cobicistat.

Sources

Study Design

In this prospective, open label, two period, randomized, cross over trial sixteen healthy adult patients were given ten days of atazanavir/cobicistat (ATV/c) 300mg/150 mg plus daclatasvir 30 mg daily followed by a washout period of ten days. Then these same patients were given ten days of atazanavir/ritonavir (ATV/r) 300mg/100mg plus daclatasvir 30 mg daily. In a second arm of this study, patients received atazanavir/ritonavir plus daclatasvir for ten days, received a washout period of ten days, and then received atazanavir/cobicistat plus daclatasvir for ten days. At steady state, PK analysis was done for daclatasvir. Geometric means ratios of daclatasvir AUC, Cmax and Ctrough with 90% confidence intervals were calculated comparing the effect of atazanavir/cobistat with the effect of atazanavir/ritonavir.

Study Results

Geometric Means Ratios (90% CI) of daclatasvir AUC, Cmax and Ctrough with ATV/c compared with ATV/r were 101% (92%-111%), 97% (89%-106%), and 101%(89%-115%), respectively

Study Conclusions

References

Smolders EJ, de_Kanter CTMM, K Velthoven-Graafland, Colbers EPH, Drenth JPH, et al. Daclatasvir 30 mg/day is the correct dose for patients taking atazanavir/cobicistat. abstract p_43. 17th International Workshop On Clinical Pharmacology Of Hiv And Hepatitis Therapy. Washington DC, USA. ; 2016.

Study Design

In this prospective, open label, two period, randomized, cross over trial sixteen healthy adult patients were given ten days of atazanavir/cobicistat (ATV/c) 300mg/150 mg plus daclatasvir 30 mg daily followed by a washout period of ten days. Then these same patients were given ten days of atazanavir/ritonavir (ATV/r) 300mg/100mg plus daclatasvir 30 mg daily. In a second arm of this study, patients received atazanavir/ritonavir plus daclatasvir for ten days, received a washout period of ten days, and then received atazanavir/cobicistat plus daclatasvir for ten days. At steady state, PK analysis was done for daclatasvir. Geometric means ratios of daclatasvir AUC, Cmax and Ctrough with 90% confidence intervals were calculated comparing the effect of atazanavir/cobistat with the effect of atazanavir/ritonavir.

Study Results

Geometric Means Ratios (90% CI) of daclatasvir AUC, Cmax and Ctrough with ATV/c compared with ATV/r were 101% (92%-111%), 97% (89%-106%), and 101%(89%-115%), respectively

Study Conclusions

References

Garimella T, You X, Wang R, Huang SP, Kandoussi H, Biffano M, Eley T. A review of daclatasvir drug-drug interactions. Advances In Therapy. 2016; 11: 1867-1884.