Sofosbuvir + Daclatasvir = Unknown or no reaction

Effect on Concentration

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

Pharmacologic Effects

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

Interaction History

N/A

Last Updated 13-Jul-2018

Summary

Sources

Daclatasvir plus sofosbuvir for HCV in patients coinfected with HIV-1. ^

Study Design

In this study the drug-drug interaction potential of daclatasvir (DCV) with sofosbuvir (SOF) was assessed in patients with chronic HCV infection. SOF was administered as 400mg QD while DCV was given as 60mg QD. **Plasma levels of GS-331007 (major circulating metabolite for SOF) were analyzed.

Study Results

Using geometric mean ratios (GMR) and 90% confidence intervals (CI), the Cmax, Cmin and AUC for DCV was 0.88 (0.78-0.99), 0.91 (0.71-1.16) and 0.95 (0.82-1.10), while the Cmax, Cmin and AUC for GS-331007 was 0.80 (0.77-0.90), 1.4 (1.35-1.53) and 1.00 (0.95-1.08), respectively. No clinically meaningful drug-drug interactions were observed when DCV was coadministered with SOF. The manufacturer states that no dose adjustment is required of either agent when this combination is utilized. Caution is advised due to dizziness reported with this combination.

Study Conclusions

Per the manufaturer, comparison for DCV exposure was to historical data from three studies of DCV 60mg QD with peg-interferon alpha and ribavirin.

References

Wyles DL, Ruane PJ, Sulkowski MS, Dietrich D, Luetkemeyer A, Morgan TR, Henn S. Daclatasvir plus sofosbuvir for hcv in patients coinfected with hiv-1. New England Journal Of Medicine. 2015; 8: 714-725.