Liverpool HEP Interactions

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No Interaction Expected

Elbasvir/Grazoprevir

Raltegravir

Summary:

Coadministration with elbasvir/grazoprevir has not been studied. Coadministration of multiple doses of elbasvir with a single dose of raltegravir had no significant effect the pharmacokinetics of raltegravir. Coadministration of multiple doses of grazoprevir and raltegravir increased raltegravir AUC by 43% (which is not considered clinically relevant for raltegravir). Raltegravir had no significant effect on the pharmacokinetics of grazoprevir and elbasvir. No dose adjustments are required.

Description:

Coadministration of raltegravir (400 mg single dose) and elbasvir (50 mg single dose) decreased elbasvir AUC, Cmax and C24 by 19%, 11% and 20%, respectively. Raltegravir AUC and Cmax increased by 2% and 9% and C12 decreased by 1%. Coadministration of raltegravir (400 mg, twice daily) and grazoprevir (200 mg single dose) decreased grazoprevir AUC, Cmax and C24 by 11%, 15% and 10%, respectively. Raltegravir AUC, Cmax and C12 increased by 43%, 46% and 47%, respectively.

Zepatier Summary of Product Characteristics, Merck Sharp & Dohme Ltd, January 2021.

The interaction between elbasvir or grazoprevir and raltegravir was evaluated in clinical studies, and no dose adjustments are needed. Coadministration of raltegravir (400 mg single dose) and elbasvir (50 mg single dose) to 10 subjects decreased elbasvir AUC, Cmax and C24 by 19%, 11% and 20%, respectively; raltegravir AUC and Cmax increased by 2% and 9%, but Ctrough decreased by 1%. Coadministration of raltegravir (400 mg twice daily) and grazoprevir (200 mg once daily) to 11 subjects, decreased grazoprevir AUC, Cmax and C24 by 11%, 15% and 10%, respectively; raltegravir AUC, Cmax and Ctrough increased by 43%, 46% and 47%, respectively.

Zepatier US Prescribing Information, Merck & Co Inc., December 2021.

Coadministration of raltegravir (400 mg single dose) and elbasvir (50 mg single dose) to 10 subjects decreased elbasvir AUC, Cmax and C24 by 19%, 11% and 20%, respectively; raltegravir AUC and Cmax increased by 2% and 9%, but Ctrough decreased by 1%. Coadministration of raltegravir (400 mg twice daily) and grazoprevir (200 mg once daily) to 11 subjects, decreased grazoprevir AUC, Cmax and C24 by 11%, 15% and 10%, respectively; raltegravir AUC, Cmax and Ctrough increased by 43%, 46% and 47%, respectively. No dose adjustments for elbasvir, grazoprevir or raltegravir are needed for co-administration in HCV/HIV-coinfected people.

Assessment of drug interaction potential between the HCV direct-acting antiviral agents elbasvir/grazoprevir and the HIV integrase inhibitors raltegravir and dolutegravir. Feng HP, Guo Z, Ross LL, et al. J Antimicrob Chemother, 2019, 74(3): 710-717.

View all available interactions with Elbasvir/Grazoprevir by clicking here.