Sofosbuvir and Ribavirin in HCV Recurrence Post Liver Transplant
Study on the efficacy of Sofosbuvir and Ribavirin in patients with HCV recurrence post liver transplantation. The phase 2 trial included 40 patients with chronic hepatitis C, offering a 24-week regimen with positive SVR12 outcomes. Key characteristics, design, dosing, and results of the treatment are presented.
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Phase 2 Treatment Na ve and Treatment Experienced Liver Transplantation Sofosbuvir + Ribavirin in HCV Recurrence Following Liver Transplantation Charlton M, et al. Gastroenterology. 2015;148:108-17.
Sofosbuvir + Ribavirin in Recurrent HCV Post Liver Transplant Sofosbuvir + Ribavirin Post Liver Transplant: Features Design: Open-label, prospective, single-arm, phase 2 trial of 24-week course of sofosbuvir + ribavirin in patients with HCV recurrence post-liver transplantation Setting: Multicenter, International Study Entry Criteria - N = 40 patients with chronic hepatitis C - Recurrent HCV infection post liver transplantation - Any genotype included - CTP score 7 and MELD score 17 - Excluded if decompensated liver disease Regimen (24 weeks) - Sofosbuvir: 400 mg once daily - Ribavirin: started at 400 mg/day and increased up to 1200 mg/day Primary End-Point: SVR12 Source: Charlton M, et al. Gastroenterology. 2015;148:108-17.
Sofosbuvir + Ribavirin in Recurrent HCV Post Liver Transplant Baseline Characteristic (n = 40) Sofosbuvir + Ribavirin x 12 weeks Median Age, years (range) 59 (49 to 75) Male sex, % 78 White, % 85 Median Body Mass Index (BMI) <30 kg/m2 (%) 75 HCV genotype 1 (%) 83 IL28B genotype CC, (%) 33 Median baseline HCV RNA, log10 IU/ml (range) 6.74 (4.49-7.59) METAVIR-equivalent fibrosis (F3 or F4), % F1-F2= 35%; F3=23%; F4=40% Previous HCV treatment, % 88 Median time since liver transplantation, years (range) 4.3 (1.0-10.6) Source: Charlton M, et al. Gastroenterology. 2015;148:108-17.
Sofosbuvir + Ribavirin in Recurrent HCV Post Liver Transplant Design 0 24 36 Week N = 40 Sofosbuvir + Ribavirin SVR12 Drug Dosing Sofosbuvir: 400 mg once daily Ribavirin: administered in two divided daily doses (started at 400 mg/day and increased up to 1200 mg/day based on hemoglobin, creatinine clearance, and weight) Source: Charlton M, et al. Gastroenterology. 2015;148:108-17.
Sofosbuvir + Ribavirin in Recurrent HCV Post Liver Transplant Results 100 100 Patients with SVR 12 (%) 80 73 70 70 60 40 20 40/40 29/40 28/40 28/40 0 End of Treatment SVR 4 SVR 12 SVR 24 Source: Charlton M, et al. Gastroenterology. 2015;148:108-17.
Sofosbuvir + Ribavirin in Recurrent HCV Post Liver Transplant Adverse Effects Sofosbuvir + Ribavirin (n=40) Event Any adverse event (%) Any serious adverse event Adverse event leading to discontinuation Adverse event occurring in >10% of patients Fatigue Diarrhea 39 (98%) 6 (15%) 2 (5%) 12 (30%) 11 (28%) Headache 10 (25%) Arthralgia 9 (23%) Nausea 8 (20%) Anemia 8 (20%) Cough 7 (18%) Insomnia 5 (13%) Anxiety 5 (13%) Source: Charlton M, et al. Gastroenterology. 2015;148:108-17.
Sofosbuvir + Ribavirin in Recurrent HCV Post Liver Transplant Conclusions Conclusions: Sofosbuvir and ribavirin combination therapy for 24 weeks is an effective and well tolerated interferon-free treatment for post-transplant HCV infection. Source: Charlton M, et al. Gastroenterology. 2015;148:108-17.
This slide deck is from the University of Washingtons Hepatitis C Online and Hepatitis Web Study projects. Hepatitis C Online www.hepatitisc.uw.edu Hepatitis Web Study http://depts.washington.edu/hepstudy/ Funded by a grant from the Centers for Disease Control and Prevention.
