1 / 11

Sofosbuvir + Simeprevir +/- Ribavirin in Genotype 1 COSMOS Trial (Cohorts 1 and 2)

Phase 2a, Treatment Naïve and Treatment Experienced. Treatment Naïve and Treatment Experienced. Sofosbuvir + Simeprevir +/- Ribavirin in Genotype 1 COSMOS Trial (Cohorts 1 and 2).

sagira
Download Presentation

Sofosbuvir + Simeprevir +/- Ribavirin in Genotype 1 COSMOS Trial (Cohorts 1 and 2)

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Phase 2a, Treatment Naïve and Treatment Experienced Treatment Naïve and Treatment Experienced Sofosbuvir + Simeprevir +/- Ribavirin in Genotype 1COSMOS Trial (Cohorts 1 and 2) SulkowskiM, et al. 49th EASL; April 2014. Abstract 07.LawitzE, et al. 49th EASL; April 2014. Abstract 165.

  2. Sofosbuvir + Simeprevir +/-Ribavirin for HCVGT 1COSMOS Trial: Study Features Source: (Cohort 1) SulkowskiM, et al. 49th EASL. April 2014. Abstract 07. (Cohort 2) Lawitz E, et al. 49th EASL. April 2014. Abstract 165.

  3. Sofosbuvir+ Simeprevir +/- Ribavirin for HCV GT 1COSMOS Trial: Design for Cohort 1 Cohort 1: Prior Null Responders; 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: Sulkowski M, et al. 49th EASL. April 2014. Abstract 07.

  4. Sofosbuvir + Simeprevir +/- 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: Sulkowski M, et al. 49th EASL. April 2014. Abstract 07.

  5. Sofosbuvir + Simeprevir +/- Ribavirin for HCV GT 1COSMOS Trial: Cohort 1 Subgroup Analysis Impact of Q80K on SVR in Patients with GT1 SOF = sofosbuvir; SMV = simeprevir; RBV = ribavirin Source: Sulkowski M, et al. 49th EASL. April 2014. Abstract 07.

  6. Sofosbuvir + Simeprevir +/- Ribavirin for HCV GT 1COSMOS Trial: Design for Cohort 2 Cohort 2: Treatment Naïve & Prior Null Responders; 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. 49th EASL. April 2014. Abstract 165.

  7. Sofosbuvir + Simeprevir +/- 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. 49th EASL. April 2014. Abstract 165.

  8. Sofosbuvir + Simeprevir +/- Ribavirin for HCV GT 1COSMOS Trial: Results COSMOS (Cohort 2 Metavir F4 Patients): SVR12 by Naïve or Null 3/3 9/9 5/5 4/4 6/6 4/5 2/3 4/4 16/17 21/22 24-Week Treatment 12-Week Treatment SOF = sofosbuvir; SMV = simeprevir; RBV = ribavirin Source: Lawitz E, et al. 49th EASL. April 2014. Abstract 165.

  9. Sofosbuvir + Simeprevir +/- Ribavirin for HCV GT 1COSMOS Trial: Cohort 2 Subgroup Analysis Impact of Q80K on SVR in Patients with GT1 SOF = sofosbuvir; SMV = simeprevir; RBV = ribavirin Source: Lawitz E, et al. 49th EASL. April 2014. Abstract 165.

  10. Sofosbuvir + Simeprevir +/- Ribavirin for HCV GT 1COSMOS Trial: Results COSMOS: Impact of Q80K on SVR in Patients with GT1 24/27 30/30 17/17 10/11 21/21 8/8 Cohort 1: SVR 12 (12 & 24-week arms) Cohort 2: SVR 4 (12-week arms) SOF = sofosbuvir; SMV = simeprevir; RBV = ribavirin Source: Jacobson IM, et al. AASLD. Nov, 2013. Abstract LB-3.

  11. 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.

More Related