Consistent with RPV label recommendations for co-administration with other drugs causing a similar magnitude of increase in RPV exposure, the authors concluded that no dose adjustments are required when RPV is administered concomitantly with these DAAs.
Raltegravir or rilpivirine vs glecaprevir/pibrentasvir
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Study Design
This was a Phase 1, randomized, single-center, mutliple-dose (non-fasting) open label study to evaluate the pharmacokinetics (PK), tolerability and safety of the combination of ABT-493 + ABT-530 (DAA) when co-administered with rilpivirine (RPV).There were two cohorts for this study, each with 12 healthy participants.Cohort 1: ABT-493 + ABT-530 (300/120mg) once daily was administered on Days 1-7 alone (Period 1). This was followed by co-administration ofABT-493 + ABT-530 (300/120mg) plus RPV 25 mg once daily on Days 1-14 in Period 2.Cohort 2:RPV 25 mgonce daily was administered on Days 1-14 alone (Period 1).This was followed by co-administration ofABT-493 + ABT-530 (300/120mg) plus RPV 25 mg once daily on Days 1-7 in Period 2.
Study Results
PK ParameterDrug [Central Value Ratios and 90% Confidence Intervals]ABT-493ABT-530RPVCmax0.87 [0.74, 1.03]0.97 [0.89, 1.05]2.05 [1.73, 2.43]AUCtau0.90 [0.79, 1.02]0.96 [0.89, 1.05]1.84 [1.72, 1.98]Ctrough0.92 [0.78, 1.08]1.00 [0.89, 1.12]1.77 [1.59, 1.96]Using central value ratios and 90% confidence intervals, following co-administration with multiple RPV doses, ABT-493 and ABT-530 Cmax, AUC24 and Ctrough were similar to when the DAA combination was administered alone.Compared to RPV alone, co-administration with the DAAs significantly increased RPV Cmax, AUC24 and Ctrough by 105%, 84% and 77%, respectively.No clinically significant vital signs, lab measurements, severe adverse events or new safety signalswere observed.
References
Oberoi RK, Kosloski MP, B Ding, et al. Interactions between abt-493 plus abt-530 combination and rilpivirine or raltegravir. Conference On Retroviruses And Opportunistic Infections. Boston, MA. ; 2016.
Raltegravir or rilpivirine vs glecaprevir/pibrentasvir
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Study Design
In a parallel 2-periods, open-label, single-center, phase I study, the pharmacokinetic (PK) drug interaction potential was assessed betweeen GLE/PIB and RPV. Healthy adults age between 18 and 55 recevied GLE 300mg/PIB 120mg (n7) once daily in period 1(Days 1-7). In period 2 (days 1-14), subjects recevied GLE/PIB with RPV 25mg once daily (n14). For assessment of the GLE/PIB plasma concentration, samples were collected on period 1 day 7 and period 2 days 1 and 14 prior dosing. For RPV, samples were collected on period 2 days 1 and 14.
Study Results
Rilpivirine exposures were elevated (Cmax increased to 2.1- fold, AUC24 increased 84, and Ctrough increased 77) when coadministered with GLE/PIB. Exposures of GLE and PIB were unaffected
Study Conclusions
PPMD Overview
PPMD Overview
100
10
T32
There is no clinically significant interactions observed between GLE/PIB and RPV.
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There is no clinically significant interactions observed between GLE/PIB and RPV.
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References
Koloski MP, et al.. Drug-drug interactions of glecaprevir and pibrentasvir coadministered with human immunodeficiency virus antiretrovirals. Journal Of Infectious Diseases. 2020; 2: 223-31.
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