LDV/SOF in kidney transplant recipients

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LDV/SOF 90/400 mg qd Non-randomised Open-label N = 21 W12 SVR 12 NIAID SYNERGY GT4 Kohli A. Lancet Infect Dis 2015; Juky 15, ePub ahead of print ≥ 18 years.

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Presentation transcript:

LDV/SOF in kidney transplant recipients Design Randomisation 1 : 1 W12 W24 > 18 years Kidney transplant since ≥ 6 months Genotype 1 or 4 Treatment-naïve or -experienced Compensated cirrhosis allowed * Hb ≥ 10 g/dl, platelet > 50 x 103/mm3, CLcreatinine ≥ 40 ml/min NO HBV or HIV co-infection N = 57 LDV/SOF LDV/SOF N = 57 * Metavir F4 or Ishak ≥ 5 or Fibroscan > 12.5 kPa or Fibrotest > 0.75 and APRI > 2 LDV/SOF 90/400 mg 1 cp QD Objective SVR12 (HCV RNA < 15 IU/ml), with 95% CI, by ITT LDV/SOF Kidney Transplant Colombo M, Ann. Intern Med 2016, 15 Nov, Epub ahead of print

LDV/SOF in kidney transplant recipients Baseline characteristics LDV/SOF 12W N = 57 LDV/SOF 24W N = 57 Median age, years 53 Female 42% White 5% 7% Median BMI, kg/m² 23 24 Genotype: 1a / 1b / 4 16% / 74% / 11% 18% / 75% / 7% Median HCV RNA, log10 IU/ml 6.4 6.2 Cirrhosis 14% 16% HCV treatment naïve 70% 68% Median eGFR, ml/min (range) 50 (37-135) 60 (35-130) Median years from transplant (range) 10 (0.5-40) 12 (0.8-42) Type of immunosupprssant drug Corticosteroids Tacrolimus Mycophenolate Cyclosporine Azathioprine 68% 42% 67% 40% 11% 74% 53% 54% 37% 14% LDV/SOF Kidney Transplant Colombo M, Ann. Intern Med 2016, 15 Nov, Epub ahead of print

LDV/SOF in kidney transplant recipients SVR12, % (ITT) 20 40 60 80 100 57 Overall 51 53 Genotype 1 6 4 Genotype 4 % LDV/SOF 12 weeks LDV/SOF 24 weeks N= Baseline NS5A RAVs (15% cutoff) present in 19% of patients: SVR12 of 100% with or without baseline RAVS LDV/SOF Kidney Transplant Colombo M, Ann. Intern Med 2016, 15 Nov, Epub ahead of print

LDV/SOF in kidney transplant recipients Adverse events, % N = 114 Any adverse event 68 Grade 3-4 AE 8 Serious AE 11 Treatment-related AE 3 * Discontinuation due to AE < 1 (N = 1) Grade 3 or 4 laboratory abnormality 22 eGFR < 30 ml/min during therapy 3.5 (N = 4, 1 related to treatment) Rejection of kidney transplant * Creatinine increased, pulmonary embolism, amiodarone-associated bradycardia with syncope LDV/SOF Kidney Transplant Colombo M, Ann. Intern Med 2016, 15 Nov, Epub ahead of print

LDV/SOF in kidney transplant recipients Summary SOF/VEL for 12 weeks resulted in overall 100% SVR12 in genotype 1 or 4 HCV-infected kidney transplant patients With or without cirrhosis And/or history of prior treatment failure No need to extend therapy to 24 weeks Treatment was safe and well tolerated, With no clinically meaningful reduction in renal function median change in creatinine clearance [eGFR by Cockcroft–Gault equation] - 0.6 to - 3 ml/min during treatment and up to post-treatment W4 LDV/SOF Kidney Transplant Colombo M, Ann. Intern Med 2016, 15 Nov, Epub ahead of print