Ledipasvir/sofosbuvir is effective and well tolerated in postkidney transplant patients with chronic hepatitis C virus

Abstract

Patients with end-stage renal diseases on hemodialysis have a high prevalence of hepatitis C infection (HCV). In most patients, treatment for HCV is delayed until postrenal transplant. We assessed the effectiveness and tolerance of ledipasvir/sofosbuvir (LDV/SOF) in 32 postkidney transplant patients infected with HCV. The group was composed predominantly of treatment-naïve (75%) African American (68.75%) males (75%) infected with genotype 1a (62.5%). Most patients received a deceased donor kidney graft (78.1%). A 96% sustained viral response (SVR) was reported (27/28 patients). One patient relapsed. One patient with baseline graft dysfunction developed borderline rejection. No graft loss was reported. Six HIV-coinfected patients were included in our analysis. Five of these patients achieved SVR 12. There were four deaths, and one of the deaths was in the HIV group. None of the deaths were attributed to therapy. Coinfected patients tolerated therapy well with no serious adverse events. Serum creatinine remained stable at baseline, end of therapy, and last follow-up, (1.351±.50 mg/dL; 1.406±.63 mg/dL; 1.290±.39 mg/dL, respectively). In postkidney transplant patients with HCV infection with or without coinfection with HIV, a combination of LDV/SOF was well tolerated and effective.

Transplantation of hepatitis C virus infected kidneys into hepatitis C virus uninfected recipients

“…There is increasing data that DAAs can be successfully used in kidney transplant recipients with low rates of adverse events and without increasing the rate of acute rejection (Table and S1). Results from 2 prospective clinical trials and 10 retrospective series of kidney transplant recipients demonstrated that more than 97% were cured with DAAs and the rate of acute rejection was less than 2% . It is important to note that nearly one‐third needed adjustment in calcineurin inhibitor dose during or shortly after stopping DAA therapy, suggesting extremely close monitoring of calcineurin inhibitor levels is needed, particularly if treatment is occurring in the early post‐transplant period.…”

“…Results from 2 prospective clinical trials and 10 retrospective series of kidney transplant recipients demonstrated that more than 97% were cured with DAAs and the rate of acute rejection was less than 2%. 9,23,[26][27][28][29][30][31][32][33][34][35] It is important to note that nearly one-third needed adjustment in calcineurin inhibitor dose during or shortly after stopping DAA therapy, suggesting extremely close monitoring of calcineurin inhibitor levels is needed, particularly if treatment is occurring in the early post-transplant period.…”

Hepatitis C virus infection in kidney transplantation‐changing paradigms with novel agents

“…There are 3 prospective trials involving DAAs in kidney transplant recipients and several retrospective studies documenting the efficacy of therapy in these patients. These studies are reviewed in Table and we emphasize a few important trials with each of the major regimens …”

“…In addition to the above prospective trials, several centers have retrospective experience with DAAs with a total of ∼321 liver and renal transplant recipients (see Table ) . The majority of patients received sofosbuvir regimens several months to years posttransplantation with an eGFR >30 mL/min/1.73 m 2 .…”

“…In addition to the above prospective trials, several centers have retrospective experience with DAAs with a total of 321 liver and renal transplant recipients (see Table 1). 12,[29][30][31][32][33][34][35][36][37][38][39][40][41] The majority of patients received sofosbuvir regimens several months to years posttransplantation with an eGFR >30 mL/min/1.73 m 2 . To date, only 7 failures were reported in the retrospective data, with 2 of them being retreated with next generation DAA regimens and subsequently achieving SVR.…”