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Simeprevir + Sofosbuvir +/- Ribavirin in Genotype 1 COSMOS Trial

Learn about the COSMOS trial examining the efficacy of Simeprevir, Sofosbuvir, and Ribavirin in treating HCV GT1 patients. Understand the treatment regimens, outcomes, and impact of Q80K mutation. Source: Lawitz E, et al. Lancet 2014;384:1756-65.

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Simeprevir + Sofosbuvir +/- Ribavirin in Genotype 1 COSMOS Trial

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  1. Phase 2a, Treatment Naïve and Treatment Experienced Treatment Naïve and Treatment Experienced Simeprevir+ Sofosbuvir +/- Ribavirin in Genotype 1COSMOS Trial LawitzE, et al. Lancet. 2014;384;1756-65.

  2. Simeprevir+ Sofosbuvir +/-Ribavirin for HCVGT 1COSMOS Trial: Study Features Source: Lawitz E, et al. Lancet. 2014;384;1756-65.

  3. Simeprevir + Sofosbuvir +/- Ribavirin for HCV GT 1COSMOS Trial: Baseline Characteristic Source: Lawitz E, et al. Lancet. 2014;384;1756-65.

  4. Simeprevir + Sofosbuvir +/- Ribavirin for HCV GT 1COSMOS Trial: Design for Cohort 1 Cohort 1: Prior Nonresponders; MetavirScores F0-F2 0 12 24 36 Week SOF + SMV + RBV N = 24 SVR12 SOF + SMV SVR12 N = 15 SOF + SMV + RBV SVR12 N = 27 SOF + SMV N = 14 SVR12 Drug DosingSOF= Sofosbuvir: 400 mg once dailySMP =Simeprevir: 150 mg once dailyRBV = Ribavirin (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;384;1756-65.

  5. Simeprevir + Sofosbuvir +/- Ribavirin for HCV GT 1COSMOS Trial: Results for Cohort 1 COSMOS (Cohort 1): SVR 12 by Regimen 19/24 14/15 26/27 13/14 24-Week Treatment 12-Week Treatment SOF = sofosbuvir; SMV = simeprevir; RBV = ribavirin Source: Lawitz E, et al. Lancet. 2014;384;1756-65.

  6. Simeprevir + Sofosbuvir +/- Ribavirin for HCV GT 1COSMOS Trial: Design for Cohort 2 Cohort 2: Treatment Naïve & Prior Nonresponders; MetavirScores F3-F4 0 12 24 36 Week SOF + SMV + RBV N = 30 SVR12 SOF + SMV SVR12 N = 16 SOF + SMV + RBV SVR12 N = 27 SOF + SMV N = 14 SVR12 Drug DosingSofosbuvir: 400 mg once dailySimeprevir: 150 mg 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;384;1756-65.

  7. Simeprevir + Sofosbuvir +/- Ribavirin for HCV GT 1COSMOS Trial: Results COSMOS (Cohort 2 with F3-F4 Fibrosis): SVR12 by Regimen 28/30 16/16 25/27 13/14 24-Week Treatment 12-Week Treatment SOF = sofosbuvir; SMV = simeprevir; RBV = ribavirin Source: Lawitz E, et al. Lancet. 2014;384;1756-65.

  8. Simeprevir + Sofosbuvir +/- Ribavirin for HCV GT 1COSMOS Trial: Results for Cohort 1 & 2 Cohort 1 & 2: SVR12 19/24 28/30 14/15 16/16 26/27 25/27 13/14 13/14 72/80 82/87 24-Week Treatment 12-Week Treatment Overall Source: Lawitz E, et al. Lancet. 2014;384;1756-65.

  9. Simeprevir + Sofosbuvir +/- Ribavirin for HCV GT 1COSMOS Trial: Results for Cohort 1 & 2 Cohort 1 & 2: SVR12 (Non-VR excluded analysis*) 19/20 28/28 13/13 15/15 26/27 25/27 13/14 13/14 71/74 81/84 24-Week Treatment 12-Week Treatment Overall *Non-VR excluded analysis = SVR12 excludes early discontinuation due to non-virologic reasons or missing data at SVR12 time point Source: Lawitz E, et al. Lancet. 2014;384;1756-65.

  10. Simeprevir + Sofosbuvir +/- Ribavirin for HCV GT 1COSMOS Trial: Results for Cohort 1 & 2 Impact of Q80K on SVR in Patients with GT1 17/18 55/62 25/31 30/31 18/19 64/68 26/27 38/40 35/37 119/130 51/58 68/72 *Q80K = Gln80Lys Source: Lawitz E, et al. Lancet. 2014;384;1756-65.

  11. Simeprevir + Sofosbuvir +/- Ribavirin for HCV GT 1COSMOS Trial: Interpretation Source: Lawitz E, et al. Lancet. 2014;384;1756-65.

  12. This slide deck is from the University of Washington’s Hepatitis C Online and Hepatitis Web Study projects. Hepatitis C Onlinewww.hepatitisc.uw.edu Hepatitis Web Studyhttp://depts.washington.edu/hepstudy/ Funded by a grant from the Centers for Disease Control and Prevention.

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