Sofosbuvir + Ledipasvir (Single Agent) = Unknown or no reaction

Effect on Concentration

Sofosbuvir
Increase
Applies within class?
No
Ledipasvir (Single Agent)
Unknown
Applies within class?
No

Pharmacologic Effects

Sofosbuvir
Effect
N/A
Applies within class?
No
Ledipasvir (Single Agent)
Effect
N/A
Applies within class?
No

Interaction History

N/A

Last Updated 22-Nov-2022

Summary

The investigators concluded that the PKs of SOF were clinically unaffected by coadministration of ledipasvir; no dose adjustment of either drug is required with coadministration. On October 10, 2014, the fixed-dose combinationledipasvir/sofosbuvir (Harvoni; 90/400 mg) was approved by the FDA for the treatment of chronic hepatitis C genotype 1 infection in adults.

Sources

Sofosbuvir vs ledipasvir (single agent) or radalbuvir or ledipasvir/radalbuvir ^

Study Design

In an open-label, fixed-sequence, cross-over study, healthy subjects in each cohort study received following treatment.Cohort 1 (n=17): single dose of sofosbuvir (SOF) 400 mg alone, followed by in combination with multiple doses of ledipasvir (formerly known as GS-5885) 90 mg once daily (QD) under fasted conditions. Cohort 2 (n=18): single dose of SOF 400 mg alone, followed by in combination with multiple doses of GS-9669 500 mg QD, and then with multiple doses of ledipasvir 90 mg plus GS-9669 500 mg QD under fed conditions.

Study Results

Concomitant administration of SOF and ledipasvir has resulted in increased SOF Cmax by 1.26 fold and AUC by 2.3 fold.These increases were not considered clinically significant, and the pharmacokinetics (PKs) of the circulating metabolite GS-331007 were unaffected.

Study Conclusions

References

P German, A Mathias, Pang PS, et al. Lack of a clinically significant pharmacokinetic drug-drug interaction between sofosbuvir (gs-7977) and gs-5885 or gs-9669 in healthy volunteers [abstract 1888]. 63rd Annual Meeting Of The American Association For The Study Of Liver Diseases (aasld). Boston. ; 2012.