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Phase 2a. Treatment Naïve and Treatment Experienced. Sofosbuvir-Ledipasvir +/- Ribavirin in GT-1 LONESTAR Trial. Source: Lawitz E, et al. Lancet. 2014:383:515-23. Ledipasvir-Sofosbuvir + /- Ribavirin in Naïve & Experienced GT1 LONESTAR Trial: Features.
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Phase 2a Treatment Naïve and Treatment Experienced Sofosbuvir-Ledipasvir +/- Ribavirin in GT-1LONESTAR Trial Source: Lawitz E, et al. Lancet. 2014:383:515-23.
Ledipasvir-Sofosbuvir +/- Ribavirin in Naïve & Experienced GT1LONESTAR Trial: Features Source: Lawitz E, et al. Lancet. 2014:383:515-23.
Ledipasvir-Sofosbuvir +/- Ribavirin in Naïve & Experienced GT1LONESTAR: Study Design 0 8 12 20 24 Week Cohort ANaïven=60 n =20 SVR12 LDV-SOF n = 21 SVR12 LDV-SOF + RBV n = 19 SVR12 LDV-SOF n = 19 SVR12 Cohort BExperiencedn=40 LDV-SOF n = 21 SVR12 LDV-SOF + RBV Abbreviations: LDV-SOF= ledipasvir-sofosbuvir; RBV = ribavirin Drug DosingLedipasvir-Sofosbuvir: 90/400 mg fixed dose combination one pill once dailyRibavirin (weight-based and divided bid): 1000 mg/day if < 75 kg or 1200 mg/day if ≥ 75 kg Source: Lawitz E, et al. Lancet. 2014:383:515-23.
Ledipasvir-Sofosbuvir +/- Ribavirin in Naïve & Experienced GT1LONESTAR Trial: Results LONESTAR: SVR 12, by Cohort and Treatment Regimen 19/20 21/21 18*/19 18/19 21/21 Cohort A: Treatment-Naive Cohort B: Experienced (with PI) *One patient lost to follow-up; LDV-SOF = ledipasvir-sofosbuvir; RBV = ribavirin; PI = protease inhibitor Source: Lawitz E, et al. Lancet. 2014:383:515-23.
Ledipasvir-Sofosbuvir +/- Ribavirin in Naïve & Experienced GT1LONESTAR Trial: Adverse Events Source: Lawitz E, et al. Lancet. 2014:383:515-23.
Ledipasvir-Sofosbuvir +/- Ribavirin in Naïve & Experienced GT1LONESTAR Trial: Conclusion Source: Lawitz E, et al. Lancet. 2014:383:515-23.
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