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Ledipasvir-Sofosbuvir + RBV in HCV GT 1,4 and Advanced Liver Disease SOLAR-1 (Cohorts A and B)

The study evaluates the efficacy and safety of Ledipasvir-Sofosbuvir combined with Ribavirin in HCV Genotype 1 and 4 patients with advanced liver disease. Results, drug dosing, and conclusion are presented.

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Ledipasvir-Sofosbuvir + RBV in HCV GT 1,4 and Advanced Liver Disease SOLAR-1 (Cohorts A and B)

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  1. Phase 2 Treatment Naïve and Treatment Experienced Ledipasvir-Sofosbuvir + RBV in HCV GT 1,4 and Advanced Liver DiseaseSOLAR-1 (Cohorts A and B) Charlton M, al. Gastroenterology. 2015; 149:649-59.

  2. Ledipasvir-Sofosbuvir + Ribavirin in Advanced Liver DiseaseSOLAR-1 (Cohorts A and B): Features Source: Charlton M, et al. Gastroenterology. 2015; 149:649-59.

  3. Ledipasvir-Sofosbuvir + Ribavirin in HCV GT 1,4SOLAR-1 (Cohort A = Pre-transplantation): Study Design 0 12 24 36 Week COHORT AGT-1,4 CTP Class B & C LDV-SOF +RBV n =53 SVR12 LDV-SOF + RBV n =55 SVR12 Abbreviations: LDV= ledipasvir; SOF = sofosbuvir; RBV = ribavirin Drug DosingLedipasvir-sofosbuvir (90/400 mg): fixed dose combination; one pill once dailyRibavirin: started at 600 mg/day and then escalated as tolerated up to maximum of 1200 mg/day N =14 Source: Charlton M, et al. Gastroenterology. 2015; 149:649-59.

  4. Ledipasvir-Sofosbuvir + Ribavirin in HCV GT 1,4SOLAR-1 (Cohort A = Pre-transplantation): Baseline Characteristics Abbreviations: CTP=Child-Turcotte-Pugh Source: Charlton M, et al. Gastroenterology. 2015; 149:649-59.

  5. Ledipasvir-Sofosbuvir + Ribavirin in HCV GT 1,4SOLAR-1 (Cohort A = Pre-transplantation): Baseline Liver Status Abbreviations: CTP=Child-Turcotte-Pugh Source: Charlton M, et al. Gastroenterology. 2015; 149:649-59.

  6. Ledipasvir-Sofosbuvir + Ribavirin in HCV GT 1,4SOLAR-1 (Cohort A= Pre-transplantation): Results SOLAR-1 Cohort A (Pre-Transplantation): SVR12 Results 45/52 44/50 26/30 24/27 19/22 20/23 Abbreviations: CTP=Child-Turcotte-Pugh 6 subjects excluded because received transplant while on study: (2 CTP B/24 week; 1 CTP 2/12 week; 3 CTP C/24 week Source: Charlton M, et al. Gastroenterology. 2015; 149:649-59.

  7. Ledipasvir-Sofosbuvir + Ribavirin in HCV GT 1,4SOLAR-1 (Cohort B = Post Transplant): Study Design 0 12 24 36 Week Cohort B GT 1, 4F0-F3CTP Class ACTP Class BCTP Class CFCH LDV-SOF +RBV n =116 SVR12 LDV-SOF + RBV n =113 SVR12 Abbreviations: CTP=Child-Turcotte-Pugh; FCH=fibrosingcholestatic hepatitis; LDV=ledipasvir; SOF=sofosbuvir; RBV=ribavirin Drug DosingLedipasvir-sofosbuvir (90/400 mg): fixed dose combination; one pill once dailyRibavirin Dosing - No cirrhosis; FCH: weight-based and divided bid(1000 mg/day if < 75 kg or 1200 mg/day if ≥ 75 kg) - CTP B, C: started at 600 mg/day and escalated up to maximum of 1200 mg/day N =14 Source: Charlton M, et al. Gastroenterology. 2015; 149:649-59.

  8. Ledipasvir-Sofosbuvir + Ribavirin in HCV GT 1,4SOLAR-1 (Cohort B = Post-transplantation): Baseline Characteristics Abbreviations: CTP=Child-Turcotte-Pugh Source: Charlton M, et al. Gastroenterology. 2015; 149:649-59.

  9. Ledipasvir-Sofosbuvir + Ribavirin in HCV GT 1,4SOLAR-1 (Cohort B = Post-transplantation): Baseline Characteristics Abbreviations: CTP=Child-Turcotte-Pugh Source: Charlton M, et al. Gastroenterology. 2015; 149:649-59.

  10. Ledipasvir-Sofosbuvir + Ribavirin in HCV GT 1,4SOLAR-1 (Cohort B = Post-transplantation): Results SOLAR-1 Cohort B (Post-Transplantation): SVR12 Results 53/55 55/56 25/26 24/25 22/26 23/26 3/5 3/4 4/4 2/2 CTP = Child-Turcotte-Pugh; FCH = fibrosingcholestatic hepatitis; 8 subjects CPT B 24 weeks Source: Charlton M, et al. Gastroenterology. 2015; 149:649-59.

  11. Ledipasvir-Sofosbuvir + RBV in Advanced Liver DiseaseSOLAR-1 (Cohorts A and B): Conclusion Source: Charlton M, et al. Gastroenterology. 2015; 149:649-59.

  12. Ledipasvir-Sofosbuvir in Prior Failure with Sofosbuvir-Based Regimen

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