Dolutegravir + Sofosbuvir/Velpatasvir = Unknown or no reaction

Effect on Concentration

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

Pharmacologic Effects

Dolutegravir
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

Sources

Dolutegravir 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 third cohort, 24 subjects were given SOF/VEL with Dolutegravir (DTF). 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

Coadministration of SOF/VEL and DTG resulted in no significant effect on pharmacokinetic (PK) parameters of SOF, GS-331007 (SOF metabolite), VEL or DTG, however, no specific values were reported. Study treatments were generally well tolerated. The majority of adverse events (AEs) were Grade 1 and there were no serious AEs. The most frequent AEs were headache and constipation.

Study Conclusions

Investigators concluded that SOF/VEL may be administered safely with DTG.

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.