Ledipasvir-Sofosbuvir +/- Ribavirin for 8 or 12 weeks in HCV GT1 ION-3

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Presentation transcript:

Ledipasvir-Sofosbuvir +/- Ribavirin for 8 or 12 weeks in HCV GT1 ION-3 Phase 3 Treatment Naïve Ledipasvir-Sofosbuvir +/- Ribavirin for 8 or 12 weeks in HCV GT1 ION-3 Source: Kowdley K, et al. N Engl J Med. 2014;370:1879-88.

Ledipasvir-Sofosbuvir for 8 or 12 Weeks in Treatment-Naïve HCV GT 1 ION-3 Study: Features ION-3 Trial Design: Open-label, randomized, phase 3, using fixed-dose combination of ledipasvir-sofosbuvir +/- ribavirin in treatment-naïve patients with GT1 HCV to explore feasibility of shortening treatment duration from 12 weeks to 8 weeks. Setting: 58 sites in United States Entry Criteria - Chronic HCV Genotype 1 (n = 647) - 18 years or older - No prior HCV treatment - Patients with cirrhosis were excluded Primary End-Point: SVR12 Source: Kowdley, K, et al. N Engl J Med. 2014;370:1879-88.

Ledipasvir-Sofosbuvir for 8 or 12 Weeks in Treatment-Naïve HCV GT 1 ION-3 Study: Study Design 8 12 20 24 GT-1 Naive n = 215 LDV-SOF SVR12 n = 216 LDV-SOF + RBV SVR12 GT-1 Naive n = 216 LDV-SOF SVR12 Drug Dosing Ledipasvir-sofosbuvir (90/400 mg): fixed dose combination; one pill once daily Ribavirin (weight-based and divided bid): 1000 mg/day if < 75 kg or 1200 mg/day if ≥ 75 kg N =14 Abbreviations: LDV= ledipasvir; SOF = sofosbuvir; RBV = ribavirin Source: Kowdley, K, et al. N Engl J Med. 2014;370:1879-88.

Ledipasvir-Sofosbuvir for 8 or 12 Weeks in Treatment-Naïve HCV GT 1 ION-3 Study: Baseline Characteristics 8 Weeks 12 Week-Treatment LDV-SOF n=215 LDV-SOF + RBV n=216 LDV-SOF Mean age, y (range) 53 (22–75) 51 (21–71) 53 (20–71) BMI, kg/m2 mean (range) 28 (18–43) 28 (18–56) 28 (19–45) Male sex, n (%) 130 (60) 117 (54) 128 (59) Race White, n (%) 164 (76) 176 (81) 177 (82) Black, n (%) 45 (21) 36 (17) 42 (19) Asian, n (%) 6 (3) 4 (2) 7 (3) HCV Genotype 1a, n (%) 171 (80) 172(68) 172 (80) 1b, n (%) 43 (20) 44 (20) IL28B CC, n (%) 56 (26) 60 (28) F3 fibrosis, n (%) 29 (13) 28 (13) HCV RNA, log10 IU/ml, mean 6.5 6.4 Source: Kowdley, K, et al. N Engl J Med. 2014;370:1879-88.

ION-3: SVR 12 by Treatment Duration and Regimen Ledipasvir-Sofosbuvir for 8 or 12 Weeks in Treatment-Naïve HCV GT 1 ION-3 Study: Results ION-3: SVR 12 by Treatment Duration and Regimen 202/215 201/216 206/216 8-Week Regimen 12-Week Regimen LDV= ledipasvir; SOF = sofosbuvir; RBV = ribavirin Source: Kowdley, K, et al. N Engl J Med. 2014;370:1879-88.

Ledipasvir-Sofosbuvir for 8 or 12 Weeks in Treatment-Naïve HCV GT 1 ION-3 Study: Conclusions Conclusions: “Ledipasvir-sofosbuvir for 8 weeks was associated with a high rate of sustained virologic response among previously untreated patients with HCV genotype 1 infection without cirrhosis. No additional benefit was associated with the inclusion of ribavirin in the regimen or with extension of the duration of treatment to 12 weeks.” Source: Kowdley, K, et al. N Engl J Med. 2014;370:1879-88.

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.