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This study explores the use of Elbasvir-Grazoprevir in the treatment of hepatitis C virus (HCV) genotype 1, 4, or 6 in PWID on opiate agonist therapy. The study features, results, drug dosing, treatment efficacy, and safety are discussed.
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Phase 2 Injection Drug Use TreatmentNaïve Elbasvir-Grazoprevirin HCV GT 1,4, or 6 in PWID* on Opiate Agonist TherapyC-EDGE CO-STAR *PWID = Persons Who Inject Drugs Dore G, et al. AALSD. 2015; Abstract 40.
Elbasvir-Grazoprevirin HCV GT 1, 4, or 6 in PWID on Opiate Agonist TherapyC-EDGE CO-STAR: Study Features Source: Dore G, et al. AALSD. 2015; Abstract 40.
Elbasvir-Grazoprevir in HCV GT 1, 4, or 6 in PWID on Opiate Agonist TherapyC-EDGE CO-STAR: Study Features 0 12 16 40 24 28 Week Treatment-naïve GT 1, 4 or 6 (N=301) Elbasvir-Grazoprevir- N=201 SVR12 Elbasvir-Grazoprevir- Placebo N=100 SVR12 Drug DosingGrazoprevir-elbasvir (100/50 mg): fixed dose combination; one pill once daily Source: Dore G, et al. AALSD. 2015; Abstract 40.
Elbasvir-Grazoprevirin HCV GT 1, 4, or 6 in PWID on Opiate Agonist TherapyC-EDGE CO-STAR: Results in Immediate Treatment Group C-EDGE CO-STAR: SVR12 Results with Full Analysis Set 184/201 144/154 28/30 11/12 1/5 *Includes one subject with mixed infection (GT 1a and 1b) who achieved SVR12 Source: Dore G, et al. AALSD. 2015; Abstract 40.
Elbasvir-Grazoprevir in HCV GT 1, 4, or 6 in PWID on Opiate Agonist TherapyC-EDGE CO-STAR: Results in Immediate Treatment Group C-EDGE CO-STAR: SVR12 Results with Modified Full Analysis Set^ 189/198 147/153 28/29 11/11 3/5 ^Excludes patients who discontinued trial for non-treatment related reasons*Includes one subject with mixed infection (GT 1a and 1b) who achieved SVR12 Source: Dore G, et al. AALSD. 2015; Abstract 40.
Elbasvir-Grazoprevirin HCV GT 1, 4, or 6 in PWID on Opiate Agonist TherapyC-EDGE CO-STAR: Results C-EDGE CO-STAR: SVR12 Results with Modified Full Analysis Set^ 151/158 38/40 83/85 106/113 83/85 106/113 Cirrhosis HCV RNA IU/ml Drug Screen ^Excludes patients who discontinued trial for non-treatment related reasons Source: Dore G, et al. AALSD. 2015; Abstract 40.
Elbasvir-Grazoprevirin HCV GT 1, 4, or 6 in PWID on Opiate Agonist TherapyC-EDGE CO-STAR: Results C-EDGE CO-STAR: Adherence Overall Source: Dore G, et al. AALSD. 2015; Abstract 40.
Elbasvir-Grazoprevir in HCV GT 1, 4, or 6 in PWID on Opiate Agonist TherapyC-EDGE CO-STAR: Safety Source: Dore G, et al. AALSD. 2015; Abstract 40.
Elbasvir-Grazoprevir in HCV GT 1, 4, or 6 in PWID on Opiate Agonist TherapyC-EDGE CO-STAR: Conclusions Source: Dore G, et al. AALSD. 2015; Abstract 40.