Efficacy and tolerability of interferon-free antiviral therapy in kidney transplant recipients with chronic hepatitis C

Fernández, Inmaculada; Muñoz‐Gómez, Raquel; Pascasio, J.M.; Baliellas, Carme; Polanco, Natalia; Esforzado, Núria; Arias, Ana; Prieto, M.; Castells, Lluı́s; Cuervas-Mons, Valentín; Hernández, Ó.; Crespo, Javier; Calleja, José Luís; Forns, Xavier; Londoño, María-Carlota

doi:10.1016/j.jhep.2016.12.020

Cited by 91 publications

(89 citation statements)

References 18 publications

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“…Because no control was available for these studies, it is difficult to attribute the worsening renal function to SOF exposure versus natural progression of disease. Furthermore, other studies involving kidney transplant recipients did not report worsening renal function with SOF‐based regimens in this population 25, 26…”

Section: Discussionmentioning

confidence: 74%

Sofosbuvir‐based regimens for the treatment of chronic hepatitis C in severe renal dysfunction

Cox-North

Hawkins

Rossiter

et al. 2017

Hepatology Communications

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Sofosbuvir (SOF) is a nonstructural 5B polymerase inhibitor with activity in all hepatitis C virus (HCV) genotypes and is the backbone of many anti‐HCV drug regimens. SOF is converted into inactive metabolites that undergo renal excretion. Patients with an estimated glomerular filtration rate (eGFR) < 30 mL/minute/1.73 m2 may experience increased drug exposure and thus potential toxicities along with decreased efficacy due to dose reduction or drug discontinuation. This is a single‐center study evaluating safety and effectiveness of SOF‐based regimens in patients with severe renal dysfunction, defined as eGFR <30 mL/minute/1.73 m2, including those receiving concurrent hemodialysis. Data were collected from patients with HCV and severe renal dysfunction who started full‐dose (400 mg) SOF‐based antiviral therapy ± ribavirin between April 2014 and February 2016. Medical records were reviewed for demographics, medical history, laboratory, radiologic imaging, echocardiography, transplant status, and liver pathologic findings. Twenty‐nine patients were identified; 12 had cirrhosis and 4 of those had decompensated cirrhosis. Fourteen patients had undergone transplantation of liver and/or kidney and were on calcineurin inhibitors, with 42% requiring dose increases or decreases while on therapy. All patients attained viral suppression on treatment, and 97% had a sustained viral response at 12 weeks posttreatment. There were no early treatment discontinuations. One death occurred posttreatment from a non‐ST elevation myocardial infarction in a patient with a history of coronary artery disease and ischemic cardiomyopathy. Conclusion: SOF‐based regimens appear safe in a broad range of patients with severe renal dysfunction, including those with decompensated cirrhosis and liver transplant. To confirm these retrospective findings, prospective studies that include SOF and SOF metabolite measurements coupled with prospective serial monitoring of electrocardiograms and echocardiograms are needed. (Hepatology Communications 2017;1:248‐255)

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Section: Discussionmentioning

confidence: 74%

Sofosbuvir‐based regimens for the treatment of chronic hepatitis C in severe renal dysfunction

Cox-North

Hawkins

Rossiter

et al. 2017

Hepatology Communications

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“…The availability of Directly Acting Antivirals (DAAs) has revolutionized the treatment of HCV infection and offers a safe and highly effective antiviral treatment option for liver transplant recipients . Even though outcomes similar to liver transplant patients would be expected, exclusive experience with new HCV therapies in the post renal transplant setting is limited …”

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confidence: 99%

Successful treatment of chronic hepatitis C infection with directly acting antivirals in renal transplant recipients

Taneja

Duseja

et al. 2018

Nephrology

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“…In the majority of patients, renal function remained stable during study period and after treatment discontinuation; in 21 cases immunosuppressive treatment needed to be adjusted, yet nobody experienced acute cellular rejection. The excellent outcome of DAA therapy of HCV in KT patients was confirmed by real-life practice studies, one above all the Spanish registry of 103 kidney-transplanted patients treated with a variety of SOF-based regimens [17], 35% with a diagnosis of compensated cirrhosis and a median time from kidney transplantation and start of antiviral treatment ranging from 1 to 561 months. Interestingly, 101 patients (98%) achieved an SVR 12 while regimens were well tolerated, except that in patients receiving ribavirin, who experienced higher rates of anemia.…”

Section: Treatment Of Kt Patientsmentioning

confidence: 81%

Antiviral treatment of hepatitis C in renal transplant patients - safety issues

Nicola

Colombo

2017

Expert Opinion on Drug Safety

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Efficacy and tolerability of interferon-free antiviral therapy in kidney transplant recipients with chronic hepatitis C

Cited by 91 publications

References 18 publications

Sofosbuvir‐based regimens for the treatment of chronic hepatitis C in severe renal dysfunction

Sofosbuvir‐based regimens for the treatment of chronic hepatitis C in severe renal dysfunction

Successful treatment of chronic hepatitis C infection with directly acting antivirals in renal transplant recipients

Antiviral treatment of hepatitis C in renal transplant patients - safety issues

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