Phase 3 Treatment Nave and Treatment Experienced Sofosbuvir
Phase 3 Treatment Naïve and Treatment Experienced Sofosbuvir + Peginterferon + Ribavirin in Genotypes 2 or 3 BOSON Trial Foster GR, et al. 50 th EASL. 2015. Abstract L 05 Hepatitis web study
Sofosbuvir + Ribavirin +/- Peginterferon for HCV GT 2 or 3 BOSON Trial: Study Features BOSON Trial: Features § Design: Randomized, multicenter, open-label trial using sofosbuvir and ribavirin with or without peginterferon for treatment naive or experienced patients with chronic HCV genotype 2 or 3 § Setting: International at 80 sites § Entry Criteria - Chronic HCV Genotype 2, treatment experienced, with cirrhosis - Chronic HCV Genotype 3, +/- treatment experienced, +/- cirrhosis - Platelet ≥ 60, 000 cells/mm 3 § End-Points: SVR 12; safety Source: Foster GR, et al. 50 th EASL. 2015. Abstract L 05. Hepatitis web study
Sofosbuvir + Ribavirin +/- Peginterferon for HCV GT 2 or 3 BOSON: Treatment Arms Week Genotype 2 Prior treatment Cirrhosis Genotype 3 +/- Prior Treatment +/- Cirrhosis 0 12 16 24 Sofosbuvir + RBV (n= 196) 28 SVR 12 Sofosbuvir + RBV (n= 199) Sofosbuvir + PEG/RBV (n= 197) 36 SVR 12 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 Peginterferon alfa-2 a: 180 ug/week Source: Foster GR, et al. 50 th EASL. 2015. Abstract L 05. Hepatitis web study
Sofosbuvir + Ribavirin +/- Peginterferon for HCV GT 2 or 3 BOSON: Results SVR 12 by Regimen and Genotype Patients with SVR 12 (%) SOF + RBV x 16 wks SOF + RBV x 24 wks 100 93 85 80 SOF + PEG + RBV x 12 wks 94 93 87 84 72 71 60 40 20 0 141/ 196 170/ 199 Overall 183/ 197 13/ 15 17/ 17 15/ 16 Genotype 2 Source: Foster GR, et al. 50 th EASL. 2015. Abstract L 05. 128/ 181 153/ 182 166/ 181 Genotype 3 Hepatitis web study
Sofosbuvir + Ribavirin +/- Peginterferon for HCV GT 2 or 3 BOSON: Results Genotype 3: SVR 12 by Regimen Patients with SVR 12 (%) SOF + RBV x 16 wks SOF + RBV x 24 wks SOF + PEG + RBV x 12 wks 100 93 80 60 84 71 40 20 0 128/181 153/182 166/181 Patients with Genotype 3 Infection Source: Foster GR, et al. 50 th EASL. 2015. Abstract L 05. Hepatitis web study
Sofosbuvir + Ribavirin +/- Peginterferon for HCV GT 2 or 3 BOSON: Results Genotype 3: SVR 12 by Regimen and Cirrhosis Status Patients with SVR 12 (%) SOF + RBV x 16 wks SOF + RBV x 24 wks SOF + PEG + RBV x 12 wks 100 95 80 88 87 80 79 60 51 40 20 99/124 0 109/126 117/123 Noncirrhotic Source: Foster GR, et al. 50 th EASL. 2015. Abstract L 05. 29/57 44/56 51/58 Cirrhotic Hepatitis web study
Sofosbuvir + Ribavirin +/- Peginterferon for HCV GT 2 or 3 BOSON: Results Genotype 3: SVR 12 by Regimen and Treatment History Patients with SVR 12 (%) SOF + RBV x 16 wks SOF + RBV x 24 wks SOF + PEG + RBV x 12 wks 100 88 80 95 91 80 77 64 60 40 20 70/91 0 83/94 89/94 Treatment Naïve Source: Foster GR, et al. 50 th EASL. 2015. Abstract L 05. 58/90 70/88 79/87 Treatment Experienced 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 Hepatitis Web Study http: //depts. washington. edu/hepstudy/ Funded by a grant from the Centers for Disease Control and Prevention. Hepatitis web study
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