Sofosbuvir + Ledipasvir/Radalbuvir = Unknown or no reaction

Effect on Concentration

Sofosbuvir
Increase
Applies within class?
No
Ledipasvir/Radalbuvir
Unknown
Applies within class?
No

Pharmacologic Effects

Sofosbuvir
Effect
N/A
Applies within class?
No
Ledipasvir/Radalbuvir
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/GS-9669; no dose adjustment of either drug is required.

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/GS-9669 has resulted in increased SOF Cmax by 3 fold and AUC by 1.4 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.