Ledipasvir and Tenofovir drug interaction in HIV-HCV co-infected patients: Impact on Tenofovir Ctrough and Renal Safety

Abstract

We evaluate the impact of ledipasvir on both tenofovir plasma trough concentration (C_trough) and estimated glomerular renal function (eGFR) in HIV-HCV co-infected patients receiving a tenofovir(TDF)-based antiretroviral regimen and treated with ledipasvir/sofosbuvir.

Twenty-six patients [81% male, median age: 51years; HCV genotype 1(75%)/4(15%)] were included. Tenofovir C_trough (interquartile:IQR) increased from 78ng/mL (53-110) at baseline to 141ng/mL (72-176) at M1 (p=0.003). No significant difference on eGFR using both Cockroft-Gault and MDRD formula, respectively [median(IQR)] was observed between baseline [101.3ml/min (91.1-114.1); 95.6ml/min (86.5-111.2)], M1 [102.4ml/min (89.8-112.9), p=0.26; 92.5ml/min (88.1-114.3), p=0.27], end-of-treatment [96.5ml/min (82.4-115.4), p=0.39; 95.4ml/min (84.2-105.4), p=0.16] and 12-weeks after the end of treatment [100.5ml/min (83.3-111.9), p=0.24; 93.4ml/min (82.2-103.5), p=0.16]. Three patients progressed from CKD stage 1 to stage 2 at PT12.

A significant increase in tenofovir exposure through P-gp inhibition by ledipasvir was confirmed without significant impact on glomerular renal function in our population with normal renal function or mild renal impairment.

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