Velpatasvir (Single Agent) + Rosuvastatin = Precautionary

Effect on Concentration

Velpatasvir (Single Agent)
Unknown
Applies within class?
No
Rosuvastatin
Increase
Applies within class?
No

Pharmacologic Effects

Velpatasvir (Single Agent)
Effect
N/A
Applies within class?
No
Rosuvastatin
Effect
N/A
Applies within class?
No

Interaction History

N/A

Last Updated 20-Jul-2018

Summary

Sources

Velpatasvir versus Rosuvastatin ^

Study Design

This was a phase 1, open label, single- and multiple dose, 5 cohort, crossover study in healthy subjects to evaluate the pharmacokinetic (PK) interaction potential between velpatasvir (VEL) and rosuvastatin (n=18).. Subjects received VEL 100mg plus rosuvastatin (dose not reported) under fasting conditions. Serial blood samples were collected over 96 hours for the PK analyses. Geometric least squares ratios and 90% confidence intervals were estimated with 70-143% bounds for analysis.

Study Results

Based on GMRs and 90% confidence intervals, there was a 169% increase in AUC (2.46, 2.94) and a 161% increase in Cmax (2.32, 2.92) of rosuvastatin. PK parameters for VEL were not reported.

Study Conclusions

This combination was generally well tolerated, with no adverse events leading to treatment discontinuation.

References

Mogalian E, German P, Yang C. Evaluation of transporter and cytochrome p450-mediated drug-drug interactions between pan-genotypic hcv ns5a inhibitor gs-5816 and phenotypic probe drugs. International Workshop On Clinical Pharmacology Of Hiv And Hepatitis T Herapy . Washington DC, USA. 15; May 2014.