Dolutegravir + Daclatasvir = Unknown or no reaction

Effect on Concentration

Dolutegravir
Increase
Applies within class?
No
Daclatasvir
No change
Applies within class?
No

Pharmacologic Effects

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

Interaction History

N/A

Last Updated 18-Jul-2018

Summary

Sources

Dolutegravir versus Daclatasvir ^

Study Design

This was an open-label, single center, 3 period crossover study in healthy adult subjects. The purpose of this study is to evaluate the pharmacokinetic change of dolutegravir 50mg (DTG) when co-administrated with daclatasvir 60mg (DCV). Participants included 12 (9 males, 3 females) healthy subjects. Sequence Period 1 Period 2 Period 3 1(n=6) DTG 50 mg daily for 5 days DCV 60 mg daily for 5 days DTG 50mg + DCV 60mg daily for 5 days 2(n=6) DCV 60 mg daily for 5 days DTG 50 mg daily for 5 days DTG 50mg + DCV 60mg daily for 5 days Washout period between period 1 and 2 = 7 days No wash out between period 2 and 3

Study Results

Plasma DTG PK Parameter Geometric Least Squares (GLS) Mean Ratio (90% CI) for DTG+DCV / DTG alone AUC 1.33 (1.11, 1.59) C max 1.29(1.07,1.57) Ct 1.45(1.25,1.68) Plasma DCV PK Parameter GLS Mean Ratio (90% CI) for DTG+DCV / DCV alone AUC 0.98 (0.83, 1.15) C max 1.03 (0.84, 1.25) Ct 1.06 (0.88, 1.29)

Study Conclusions

No dose adjustments are required when coadministering DTG and DCV.The authors state that increases in DTG PK remained in the range observed in clinical trials with HIV-infected patients and did not confer significant safety risks.

References

Ross LL, Song IH, Arya N, Choukour M, Zong J, Huang SP, Buchanan AM. No clinically significant pharmacokinetic interactions between dolutegravir and daclatasvir in healthy adult subjects. Bmc Infectious Diseases. 2016; 1: 347.