Hepatitis web study Hepatitis web study Sofosbuvir + Ribavirin in HCV Genotype 1 NIAID/NIH Trial Phase 2, Treatment Naïve Treatment Naïve (unfavorable.

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Presentation transcript:

Hepatitis web study Hepatitis web study Sofosbuvir + Ribavirin in HCV Genotype 1 NIAID/NIH Trial Phase 2, Treatment Naïve Treatment Naïve (unfavorable baseline treatment characteristics) Osinusi A, et al. JAMA. 2013;310:

Hepatitis web study Source: Osinusi A, et al. JAMA. 2013;310: Sofosbuvir and Ribavirin for Treatment-Naïve HCV GT 1 NIAID/NIH Trial: Features

Hepatitis web study Source: Osinusi A, et al. JAMA. 2013;310: Part 2 N =50 Sofosbuvir + RBV (low-dose) 24 weeks Sofosbuvir + RBV (low-dose) 24 weeks Sofosbuvir + RBV (wt-based) 24 weeks Sofosbuvir + RBV (wt-based) 24 weeks Part 1 N =10 SVR24 Sofosbuvir and Ribavirin for Treatment-Naïve HCV GT 1 NIAID/NIH Trial: Design 48 Week 024 SVR24 Sofosbuvir + RBV (wt-based) 24 weeks Sofosbuvir + RBV (wt-based) 24 weeks SVR24 N =25 Drug Dosing Sofosbuvir: 400 mg once daily Low-dose Ribavirin (divided bid): 800 mg/day Weight-based Ribavirin (divided bid): 1000 mg/day if < 75kg or 1200 mg/day if ≥ 75kg

Hepatitis web study Sofosbuvir and Ribavirin for Treatment-Naïve HCV GT 1 NIAID/NIH Study: Part 1 Results NIAID Part 1: HCV <12 IU/ml by Study Timepoint Source: Osinusi A, et al. JAMA. 2013;310: All 10 patients in Part 1 received sofosbuvir plus weight-based ribavirin 8/109/10

Hepatitis web study Sofosbuvir and Ribavirin for Treatment-Naïve HCV GT 1 NIAID/NIH Study: Part 2 Results NIAID/NIH Part 2: HCV RNA <12 IU/ml by Study Timepoint Source: Osinusi A, et al. JAMA. 2013;310: SOF = Sofosbuvir; RBV = Ribavirin 24/25 22/2524/2512/2517/25

Hepatitis web study Sofosbuvir and Ribavirin for Treatment-Naïve HCV GT 1 NIAID/NIH Study: Part 2 Results NIAID/NIH Part 2: SVR24 by Fibrosis Stage Source: Osinusi A, et al. JAMA. 2013;310: SOF = Sofosbuvir; RBV = Ribavirin 3/62/714/1910/18

Hepatitis web study Sofosbuvir and Ribavirin for Treatment-Naïve HCV GT 1 NIAID/NIH Study: Part 2 Results NIAID/NIH Part 2: SVR24 by Baseline HCV RNA Level Source: Osinusi A, et al. JAMA. 2013;310: SOF= Sofosbuvir; RBV = Ribavirin 7/99/1110/163/14

Hepatitis web study Source: Osinusi A, et al. JAMA. 2013;310: Sofosbuvir and Ribavirin for Treatment-Naïve HCV GT 1 NIAID Trial: Conclusions Conclusion: “In conclusion, treatment with a 24-week regimen of sofosbuvir and ribavirin resulted in an SVR rate of 68% in the weight-based ribavirin regimen and 48%in the low-dose ribavirin regimen among patients with chronic HCV and unfavorable traditional predictors of treatment response who are representative of the demographics of the US HCV epidemic.”

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.