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SOF/VEL in liver transplantation with genotype 1-4 infection

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Presentation on theme: "SOF/VEL in liver transplantation with genotype 1-4 infection"— Presentation transcript:

1 SOF/VEL in liver transplantation with genotype 1-4 infection
ARV-trial.com SOF/VEL in liver transplantation with genotype 1-4 infection Design W12 Open label Phase II ≥ 18 years Chronic HCV infection, genotype 1-4 Liver transplantation ≥ 3 months ago Treatment naive or experienced (apart from prior NS5A treatment) No cirrhosis or compensated cirrhosis No HBV or HIV coinfection N = 79 SOF/VEL Glucocorticoids at dose ≤ 5 mg/day permitted Treatment regimens Co-formulated SOF/VEL 400/100 mg 1 pill QD Objective SVR12 (HCV RNA < 15 IU/mL), by intention to treat, with 95% CI, descriptive analysis SOF/VEL Liver Transplant Agarwal K, J Hepatol 2018; May 29 (ePub ahead of print) 1

2 SOF/VEL in liver transplantation with genotype 1-4 infection
ARV-trial.com SOF/VEL in liver transplantation with genotype 1-4 infection Baseline characteristics and treatment response (N = 79) Demographics and clinical characteristics Mean age, years 62 Female, % 19 Genotype 1a / 1b / 2 / 3 / 4, % 19 / 28 / 4 / 44 / 5 IL28B CC genotype, % 49 HCV RNA log10 IU/ml, mean ± SD 6.4 ± 0.55 Cirrhosis, % 18 Prior HCV treatment, % 59 Time since liver transplantation, years, median 7.5 Tacrolimus / mycophenolic acid / cyclosporine, % 71 / 24 / 14 SVR12, % All patients 96 * (76/79) Genotype 1 / 2 / 3 / 4 95 / 100 / 97 / 100 * 1 non-virologic failure (discontinuation for AE at D7: hyperglycemia) ; 1 relapse at post-treatment W4 (genotype 1a, non-cirrhotic, treatment-naive), at failure: emergence of NS5A RAS L31V ; 1 relapse at post-treatment W12 (genotype 3b, non-cirrhotic, treatment-experienced without DAA), at failure: emergence of NS5B RAS S282T SOF/VEL Liver Transplant Agarwal K, J Hepatol 2018; May 29 (ePub ahead of print) 2

3 SOF/VEL in liver transplantation with genotype 1-4 infection
Adverse events and laboratory abnormalities in the 79 patients, N (%) Adverse event leading to discontinuation 1 (1%)* Serious adverse events 3 (4%) ** Adverse event in ≥ 10% Headache 24% Fatigue 20% Cough 10% Grade 3-4 laboratory abnormality Hyperuricemia 5% Hyperglycemia 4% Lymphocytopenia Proteinuria 1% * Hyperglycemia on D4 in a patient with diabetes ; ** Hepatocellular carcinoma, joint swelling, pneumonia No graft rejection and no death SOF/VEL Liver Transplant Agarwal K, J Hepatol 2018; May 29 (ePub ahead of print)

4 SOF/VEL in liver transplantation with genotype 1-4 infection
ARV-trial.com SOF/VEL in liver transplantation with genotype 1-4 infection Summary The single-tablet regimen of SOF/VEL was well tolerated and highly effective in genotype 1-4 HCV-infected liver transplant recipients. SOF/VEL is a pangenotypic, ribavirin-free, simple, and well-tolerated treatment option for HCV-infected liver transplant recipients. SOF/VEL Liver Transplant Agarwal K, J Hepatol 2018; May 29 (ePub ahead of print) 4

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