Hepatitis web study Hepatitis web study Sofosbuvir + Ribavirin in HCV Recurrence Following Liver Transplantation Phase 2 Charlton M, et al. Gastroenterology.

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Presentation transcript:

Hepatitis web study Hepatitis web study Sofosbuvir + Ribavirin in HCV Recurrence Following Liver Transplantation Phase 2 Charlton M, et al. Gastroenterology. 2015;148: Treatment Naïve and Treatment Experienced Liver Transplantation

Hepatitis web study Source: Charlton M, et al. Gastroenterology. 2015;148: Sofosbuvir + Ribavirin in Recurrent HCV Post Liver Transplant

Hepatitis web study Source: Charlton M, et al. Gastroenterology. 2015;148: 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/m 2 (%)75 HCV genotype 1 (%)83 IL28B genotype CC, (%)33 Median baseline HCV RNA, log 10 IU/ml (range)6.74 ( ) 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 ( )

Hepatitis web study Source: Charlton M, et al. Gastroenterology. 2015;148: Sofosbuvir + Ribavirin in Recurrent HCV Post Liver Transplant Design 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) Sofosbuvir + Ribavirin N = 40 SVR Week

Hepatitis web study Source: Charlton M, et al. Gastroenterology. 2015;148: Sofosbuvir + Ribavirin in Recurrent HCV Post Liver Transplant Results 40/4028/40 29/40

Hepatitis web study Source: Charlton M, et al. Gastroenterology. 2015;148: Sofosbuvir + Ribavirin in Recurrent HCV Post Liver Transplant Adverse Effects EventSofosbuvir + Ribavirin (n=40) Any adverse event (%)39 (98%) Any serious adverse event6 (15%) Adverse event leading to discontinuation2 (5%) Adverse event occurring in >10% of patients Fatigue12 (30%) Diarrhea11 (28%) Headache10 (25%) Arthralgia9 (23%) Nausea8 (20%) Anemia8 (20%) Cough7 (18%) Insomnia5 (13%) Anxiety5 (13%)

Hepatitis web study Source: Charlton M, et al. Gastroenterology. 2015;148: 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.”

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 Hepatitis Web Study 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 Hepatitis Web Study Funded by a grant from the Centers for Disease Control and Prevention.