Raltegravir + Sofosbuvir/Velpatasvir = Unknown or no reaction

Effect on Concentration

Raltegravir
No change
Applies within class?
No
Sofosbuvir/Velpatasvir
No change
Applies within class?
No

Pharmacologic Effects

Raltegravir
Effect
N/A
Applies within class?
No
Sofosbuvir/Velpatasvir
Effect
N/A
Applies within class?
No

Interaction History

N/A

Last Updated 18-Jul-2018

Summary

Use caution is using with tenofovir containing regimens.

Sources

Raltegravir versus Sofosbuvir/Velpatasvir ^

Study Design

Nine cohorts in two phase I, open-label, randomized, multiple-dose cross-over studies in healthy volunteers compared the pharmacokinetics of sofosbuvir/velpatasvir (SOF/VEL) when given alone versus when this fixed dose combination was given with several antiretroviral medications. In the fourth cohort, 30 subjects were given SOF/VEL with a fixed dose combination of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) and raltegravir (RTG). Steady state pharmacokinetic samples were collected over 24 hours on the last day of dosing for each treatment. Geometric Least Square Means Ratios and 90% confidence intervals (combination vs alone) were estimated and compared against a lack of PK alteration boundaries of 70 – 143% for all analyses. Safety of these medications was also evaluated using standard laboratory values and physical examination.

Study Results

Co-administration of SOF/VEL with FTC/TDF and RTG did not appear to impact the exposure to VEL, SOF or GS-331007 (the active metabolite of SOF). There was no significant effect of SOF/VEL on exposures to RTG. . Co-administration of SOF/VEL with TDF containing regimens increased the exposure of TDF by 40-81%, and in this arm TDF exposures increased by 40%. There does not appear to be any impact of SOF/VEL on tenofovir alafenamide (TAF) or tenofovir derived from TAF.

Study Conclusions

According to the authors, there is no significant pharmacokinetic interaction between SOF/VEL and raltegravir, and coadministration of these agents can be done without concern. However, no guidance has been offered regarding the potential drug interaction between SOF/VEL and tenofovir disoproxil fumarate, and clinical judgement should be utilized.

References

Mogalian E, McNally J, Shen G, Moorehead L, Sajwani K, Smith B, Mathias A. Drug-drug interaction profile of sofosbuvir/velpatasvir fixed-dose combination. Journal Of Hepatology. 2016; 2: S313-S314.