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Hepatitis web study Hepatitis web study Sofosbuvir + Ribavirin to Prevent Post-Transplant HCV Recurrence Phase 2 Curry MP, et al. Gastroenterology. 2015;148:100-7. Treatment Naïve and Treatment Experienced Liver Transplantation
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Hepatitis web study Source: Curry MP, et al. Gastroenterology. 2015;148:100-7. Sofosbuvir + Ribavirin to Prevent Post-Transplant HCV Recurrence
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Hepatitis web study Source: Curry MP, et al. Gastroenterology. 2015;148:100-7. Sofosbuvir + Ribavirin to Prevent Post-Transplant HCV Recurrence Study Design 92 screened 63 enrolled 61 dosed 46 underwent liver transplantation 43 with HCV RNA <LLOQ at transplantation These 43 patients analyzed for post-transplant SVR
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Hepatitis web study Source: Curry MP, et al. Gastroenterology. 2015;148:100-7. Sofosbuvir + Ribavirin to Prevent Post-Transplant HCV Recurrence Study Design Drug Dosing Sofosbuvir: 400 mg once daily Ribavirin (weight-based and divided bid): 1000 mg/day if < 75 kg or 1200 mg/day if ≥ 75 kg Sofosbuvir + Ribavirin N = 61 SVR12 Week 0Post-12241248 Treatment for 12 to 48 weeks while awaiting liver transplant Dosing discontinued within 24 hours before transplantation Liver Transplant Required Duration
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Hepatitis web study Source: Curry MP, et al. Gastroenterology. 2015;148:100-7. Sofosbuvir + Ribavirin to Prevent Post-Transplant HCV Recurrence Baseline Characteristic (n = 40) All patients dosed (N=61) Patients with HCV RNA <25 IU/mL at time of transplant (N=43) Median Age, years59 Male sex, %8074 White, %9093 Median Body Mass Index (BMI) kg/m 2 27.427.1 HCV genotype 1 (%)7372 IL28B genotype CC, (%)2223 Median baseline HCV RNA, log 10 IU/ml 6.26.3 Previous HCV treatment, %7579
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Hepatitis web study Sofosbuvir + Ribavirin to Prevent Post-Transplant HCV Recurrence Virologic Response at Transplant and Post-Transplant Source: Curry MP, et al. Gastroenterology. 2015;148:100-7. 43/4630/43
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Hepatitis web study Sofosbuvir + Ribavirin to Prevent Post-Transplant HCV Recurrence Virologic Response at Transplant and Post-Transplant Source: Curry MP, et al. Gastroenterology. 2015;148:100-7. 43/4631/4330/4331/43 Data for the 43 patients with HCV RNA <25 IU/mL at time of transplant
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Hepatitis web study Source: Curry MP, et al. Gastroenterology. 2015;148:100-7. Sofosbuvir + Ribavirin to Prevent Post-Transplant HCV Recurrence Duration of Undetectable HCV RNA and Risk of Recurrence 5004003001002000 1.00 0.75 0.50 0.25 0.00 Days Continuously Target Not Detected Probability of No Recurrence Median duration of undetectable HCV RNA prior to transplant - Patients with recurrent HCV = 5.5 days - Patients without recurrent HCV = 99.5 days
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Hepatitis web study Source: Curry MP, et al. Gastroenterology. 2015;148:100-7. Sofosbuvir + Ribavirin to Prevent Post-Transplant HCV Recurrence EventSofosbuvir + Ribavirin (N=61) Any adverse event (%)54 (8%) Any serious adverse event11 (18%) Hemoglobin decrease to <10 g/dL18 (30%) Hemoglobin decrease to <8.5 g/dL3 (5%) Adverse event occurring in >10% of patients Fatigue23 (38%) Headache14 (23%) Nausea10 (16%) Rash9 (15%) Cough7 (11%) Dyspnea7 (11%) Insomnia7 (11%)
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Hepatitis web study Source: Curry MP, et al. Gastroenterology. 2015;148:100-7. Sofosbuvir + Ribavirin to Prevent Post-Transplant HCV Recurrence Conclusions Conclusions: “Administration of sofosbuvir and ribavirin before liver transplantation can prevent post-transplant HCV recurrence.”
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Hepatitis web study Hepatitis web study This slide deck is from the University of Washington’s Hepatitis C Online and Hepatitis Web Study projects. Hepatitis C Online www.hepatitisc.uw.edu www.hepatitisc.uw.edu Hepatitis Web Study http://depts.washington.edu/hepstudy/ http://depts.washington.edu/hepstudy/ Funded by a grant from the Centers for Disease Control and Prevention. This slide deck is from the University of Washington’s Hepatitis C Online and Hepatitis Web Study projects. Hepatitis C Online www.hepatitisc.uw.edu www.hepatitisc.uw.edu Hepatitis Web Study http://depts.washington.edu/hepstudy/ http://depts.washington.edu/hepstudy/ Funded by a grant from the Centers for Disease Control and Prevention.
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