Session Time: 8:30am-9:30am
Presentation Time: 8:30am-8:45am
Location: Veterans Auditorium
Background and Aims: Interferon (IFN) and ribavirin (RBV) for the treatment of chronic hepatitis C (HCV) in kidney transplant recipients is complicated by the risk of the allograft rejection and poor tolerability. We evaluated the safety and efficacy of the IFN-free, RBV-free regimen of ledipasvir/sofosbuvir (LDV/SOF) in chronic genotype (GT) 1 or 4 HCV infected kidney transplant recipients.
Methods: Kidney transplant recipients with chronic GT1 or GT4 HCV infection, treatment-naïve and treatment-experienced, with or without compensated cirrhosis were randomized 1:1 at 5 sites in Europe to receive LDV/SOF (90 mg/400 mg) for 12 or 24 weeks. Randomization was stratified by HCV genotype, treatment history and presence or absence of cirrhosis. Cirrhosis was determined by liver biopsy (Metavir score = 4 or Ishak score ≥5), Fibroscan® >12.5 kPa, or Fibrotest® >0.75 and APRI >2. A pretreatment creatinine clearance <40 mL/min was an exclusionary criterion. The primary endpoint was SVR12.
Results: 114 patients were randomized and treated; median age was 53, 58% were male, 94% were white, 72% carried the non-CC IL28B allele, 91% had genotype 1 infection, 69% were treatment-naïve, and 15% had compensated cirrhosis. The median eGFR was 56ml/min (range 35-135ml/min). All 92 patients with SVR4 data available achieved SVR4 including a patient discontinuing treatment at Week 4 due to an AE. SAEs were reported in 12 (11%) patients; 3 were assessed as treatment related: syncope, pulmonary embolism, and blood creatinine increased. The most frequent AEs were headache (19%), asthenia (13%), and fatigue (10%).
Conclusions: Administration of LDV/SOF for 12 or 24 weeks in patients with chronic HCV genotype 1 or 4 patients who have undergone kidney transplant was safe and highly effective with an SVR4 rate of 100%. Treatment was well-tolerated. SVR12 data for all patients will be presented.
CITATION INFORMATION: Pol S, Aghemo A, Lin L, Hyland R, Yun C, Spellman J, Natha M, Brainard D, McHutchison J, Bourlière M, Peck-Radosavljevic M, Michael M, Colombo M. Ledipasvir/Sofosbuvir (LDV/SOF) for 12 or 24 Weeks Is Safe and Effective in Kidney Transplant Recipients with Chronic Genotype 1 or 4 HCV Infection. Am J Transplant. 2016;16 (suppl 3).
To cite this abstract in AMA style:Pol S, Aghemo A, Lin L, Hyland R, Yun C, Spellman J, Natha M, Brainard D, McHutchison J, Bourlière M, Peck-Radosavljevic M, Michael M, Colombo M. Ledipasvir/Sofosbuvir (LDV/SOF) for 12 or 24 Weeks Is Safe and Effective in Kidney Transplant Recipients with Chronic Genotype 1 or 4 HCV Infection. [abstract]. Am J Transplant. 2016; 16 (suppl 3). http://atcmeetingabstracts.com/abstract/ledipasvirsofosbuvir-ldvsof-for-12-or-24-weeks-is-safe-and-effective-in-kidney-transplant-recipients-with-chronic-genotype-1-or-4-hcv-infection/. Accessed September 26, 2017.
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