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

Effect on Concentration

Raltegravir
No change
Applies within class?
No
Ledipasvir (Single Agent)
No change
Applies within class?
No

Pharmacologic Effects

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

Interaction History

N/A

Last Updated 16-Jul-2018

Summary

**For information on the interaction between RAL and the combination LDV/SOF formulation please refer to the RAL vs LDV/SOF entry.

Sources

Drug-drug interaction profile of the fixed dose combination tablet ledipasvir/sofosbuvir. ^

Study Design

The drug-drug interaction potential of ledipasvir (LDV) with raltegravir (RAL) was assessed in a Phase 1, open label, randomized, crossover study in healthy adults. RAL was administered as 400mg BID and LDV as 90mg QD in the fed state. Each agent alone, as well as the combination was administered for 10 days in different sequences. Plasma samples for PK analysis were collected over 24 hours for LDV and 12 hours for RAL.

Study Results

The geometric mean ratio (GMR) (90% CI) for co-administration of LDV with RAL resulted in an AUC, Cmax and Cmin of 0.85 (0.70-1.02), 0.82 (0.67-1.02) and 1.15 (0.90-1.46), respectively, for RAL (n=28). No effect of RAL was observed on LDV PK. The GMR (90% CI) of the AUC, Cmax and Cmin of LDV were 0.92 (0.84-1.00), 0.92 (0.85-1.00) and 0.89 (0.81-0.98), respectively.

Study Conclusions

No effect of RAL was observed on LDV concentrations

References

German P, Pang PS, Fang L. Drug-drug interaction profile of the fixed dose combination tablet ledipasvir/sofosbuvir. American Association For The Study Of Liver Diseases. . Boston, MA, USA. ; November 2014.