Liverpool HEP Interactions

No Interaction Expected

Elbasvir/Grazoprevir

Tenofovir-DF (HIV)

Summary:

The interaction between elbasvir/grazoprevir and tenofovir-DF was evaluated in clinical studies, and no dose adjustments are required. There was no clinically significant effect on tenofovir pharmacokinetics when administered with elbasvir (tenofovir AUC, Cmax, Ctrough increased by 34%, 47%, 29%) or grazoprevir (tenofovir AUC, Cmax, Ctrough increased by 18%, 14% and 24%). Tenofovir-DF had no clinically significant effect on elbasvir (AUC, Cmax, C24 decreased by 7%, 12% and 8%) or grazoprevir (AUC, Cmax, C24 decreased by 14%, 22% and 11%).

Description:

Coadministration of tenofovir-DF (300 mg once daily) and elbasvir (50 mg once daily) decreased elbasvir AUC, Cmax and C24 by 7%, 12% and 8%, respectively; tenofovir AUC, Cmax and C24 increased by 34%, 47% and 29%, respectively. Coadministration of tenofovir-DF (300 mg once daily) and grazoprevir (200 mg once daily) decreased grazoprevir AUC, Cmax and C24 by 14%, 22% and 11%, respectively; tenofovir AUC, Cmax and C24 increased by 18%, 14% and 24%, respectively. Coadministration of tenofovir-DF (300 mg once daily) and elbasvir/grazoprevir (50/200 mg once daily) increased tenofovir AUC, Cmax and C24 by 27%, 14% and 23%, respectively. No dose adjustment is required.

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

The interaction between elbasvir or grazoprevir and tenofovir was evaluated in clinical studies, and no dose adjustments are needed. Coadministration of tenofovir disoproxil fumarate (300 mg once daily) and elbasvir (50 mg once daily) to 10 subjects decreased elbasvir AUC, Cmax and C24 by 7%, 12% and 8%, respectively; tenofovir AUC, Cmax and Ctrough increased by 34%, 47% and 29%, respectively. Coadministration of tenofovir disoproxil fumarate (300 mg once daily) and grazoprevir (200 mg once daily) to 12 subjects decreased grazoprevir AUC, Cmax and C24 by 14%, 22% and 11%, respectively; tenofovir AUC, Cmax and Ctrough increased by 18%, 14% and 24%, respectively. Coadministration of tenofovir disoproxil fumarate (300 mg, once daily) with elbasvir/grazoprevir (50/100 mg, once daily) was studied in 13 volunteers. Tenofovir AUC, Cmax and C24 increased by 27%, 14% and 23%, respectively.

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

Coadministration of tenofovir disoproxil fumarate (300 mg once daily) and elbasvir alone (50 mg once daily, n=10), grazoprevir alone (200 mg once daily, n=12), or elbasvir/grazoprevir (50/100 mg once daily, n=13) was studied in HIV/HCV-negative subjects. Elbasvir AUC, Cmax and C24 all decreased by ~10%; grazoprevir AUC, Cmax and C24 decreased by ~10%, ~20% and ~10% respectively. Tenofovir AUC and Cmax and C24 increased by 34%, 47% and ~30% with elbasvir alone and by 18%, 14% and ~20% with grazoprevir alone; administration with elbasvir/grazoprevir increased tenofovir AUC, Cmax and C24 by 27%, 14% and ~20%, respectively. No dose adjustments for elbasvir/grazoprevir or tenofovir-DF are needed for coadministration in HCV/HIV-coinfected people.

Assessment of drug interaction potential between the hepatitis C virus direct-acting antiviral agents elbasvir/grazoprevir and the nucleotide analog reverse-transcriptase inhibitor tenofovir disoproxil fumarate. Feng HP, Guo Z, Caro L, et al. Clin Pharmacol Drug Dev, 2019, (7):962-970.

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