Phase 3 Treatment Naïve and Treatment Experienced Sofosbuvir in Genotypes 2 or 3 VALENCE Trial Zeuzem S, et al. N Engl J Med. 2014;370:1993-2001
Sofosbuvir and Ribavirin for HCV GT 2 or 3 VALENCE Trial: Study Features VALENCE Trial: Features Design : Randomized, phase 3, using sofosbuvir + ribavirin in treatment naive or experienced, chronic HCV GT 2 or 3 Setting : Europe Entry Criteria - Chronic HCV Genotype 2 or 3 - Treatment naïve or treatment experienced - Platelet ≥ 50,000 Patient Characteristics (range in different treatment arms) - N = 419 - Sex: male (55-62%) - Race: white (89-100%) - Cirrhosis: (14-23%) - IL28B Genotype: non-CC (64-74%) End-Points : Primary = SVR12; Secondary = safety Source: Zeuzem S, et al. N Engl J Med. 2014;370:1993-2001.
Sofosbuvir and Ribavirin for HCV GT 2 or 3 VALENCE: Treatment Arms Week 0 12 24 36 Sofosbuvir + RBV GT 2 SVR12 (n = 73) Sofosbuvir + RBV GT 3 SVR12 (n = 250) Note: 85 patients enrolled in placebo arm Original Study Protocol : Placebo versus 12 weeks treatment for GT 2 and 3. Amended Protocol : GT3 treatment extended from 12 to 24 weeks; Placebo arm offered alternative treatment 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 Source: Zeuzem S, et al. N Engl J Med. 2014;370:1993-2001.
Sofosbuvir and Ribavirin for HCV GT 2 or 3 VALENCE: Results for Treatment Naïve and Experienced VALENCE: SVR12 by Genotype 100 93 80 85 Patient (%) with SVR 12 60 40 20 68/73 213/250 0 Genotype 2 Genotype 3 12-week Treatment 24-week Treatment Source: Zeuzem S, et al. N Engl J Med. 2014;370:1993-2001.
Sofosbuvir and Ribavirin for HCV GT 2 or 3 VALENCE: Results VALENCE: SVR12 by Genotype and Prior Treatment Experience All Treatment-Naïve Treatment-Experienced 100 97 94 93 Patients (%) with SVR12 90 80 85 79 60 40 20 68/73 31/32 37/41 213/250 99/105 114/145 0 Genotype 2 Genotype 3 Source: Zeuzem S, et al. N Engl J Med. 2014;370:1993-2001.
Sofosbuvir and Ribavirin for HCV GT 2 or 3 VALENCE: Results for GT 2 VALENCE: GT 2 SVR12, by Treatment Experience & Liver Disease 100 100 97 94 Patients (%) with SVR12 80 78 60 40 20 29/30 2/2 7/9 30/32 0 Noncirrhotic Cirrhotic Noncirrhotic Cirrhotic Treatment-Naive Treatment-Experienced Source: Zeuzem S, et al. N Engl J Med. 2014;370:1993-2001.
Sofosbuvir and Ribavirin for HCV GT 2 or 3 VALENCE: Results for GT 3 VALENCE: GT 3 SVR12, by Treatment Experience & Liver Disease 100 95 92 Patients (%) with SVR12 87 80 60 62 40 20 87/92 12/13 85/98 29/47 0 Noncirrhotic Cirrhotic Noncirrhotic Cirrhotic Treatment-Naive Treatment-Experienced Source: Zeuzem S, et al. N Engl J Med. 2014;370:1993-2001.
Sofosbuvir and Ribavirin for HCV GT 2 or 3 VALENCE: Conclusions Conclusions : “ Therapy with sofosbuvir – ribavirin for 12 weeks in patients with HCV genotype 2 infection and for 24 weeks in patients with HCV genotype 3 infection resulted in high rates of sustained virologic response.” Source: Zeuzem S, et al. N Engl J Med. 2014;370:1993-2001
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.
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