1 / 10

Daclatasvir + Sofosbuvir +/- Ribavirin in Genotypes 1-3 A1444-040 Trial

Phase 2a . Treatment Naïve and Treatment Experienced. Daclatasvir + Sofosbuvir +/- Ribavirin in Genotypes 1-3 A1444-040 Trial. Sulkowski MS, et al. N Engl J Med. 2014;370:211-21 . Daclatasvir + Sofosbuvir + /- Ribavirin for HCV GT 1-3 A1444 -040 Trial : Features.

gaston
Download Presentation

Daclatasvir + Sofosbuvir +/- Ribavirin in Genotypes 1-3 A1444-040 Trial

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 Daclatasvir+ Sofosbuvir +/- Ribavirin in Genotypes 1-3A1444-040 Trial Sulkowski MS, et al. N Engl J Med. 2014;370:211-21.

  2. Daclatasvir + Sofosbuvir +/-Ribavirin for HCVGT 1-3A1444-040 Trial: Features Source: Sulkowski MS, et al. N Engl J Med. 2014;370:211-21.

  3. Daclatasvir + Sofosbuvir +/- Ribavirin for HCV GT 1-3A1444-040 Design: Treatment-Naïve 24 Week Rx 0 12 24 36 Week n =16 Rx Naïve GT 2 or 3n = 44 SVR12 SOF × 7 days, then DCV + SOF n = 14 SVR12 DCV + SOF n = 14 SVR12 DCV + SOF + RBV n =15 Rx Naïve GT 1a/1bn = 44 SVR12 SOF × 7 days, then DCV + SOF n = 14 SVR12 DCV + SOF n = 15 SVR12 DCV + SOF + RBV Drug DosingDaclatasvir (DCV): 60 mg once dailySofosbuvir (SOF): 400 mg once dailyRibavirin (RBV): GT1, given weight-based and divided bid(1000 mg/day if < 75 kg or 1200 mg/day if ≥ 75 kg)Ribavirin (RBV): GT 2,3(800 mg/day) N =14 Source: Sulkowski MS, et al. N Engl J Med. 2014;370:211-21.

  4. Daclatasvir + Sofosbuvir +/- Ribavirin for HCV GT 1-3Design: GT1 Treatment-Naïve & Experienced 12 Week Rx 0 12 24 Week Rx Naïve GT 1a/1bn = 82 n = 41 SVR12 DCV + SOF n = 41 SVR12 DCV + SOF + RBV Rx Experienced GT 1a/1bPrior Boceprevir- or Telaprevir failuren = 41 n = 21 SVR12 DCV + SOF n = 20 SVR12 DCV + SOF + RBV Drug DosingDaclatasvir (DCV): 60 mg once dailySofosbuvir (SOF): 400 mg once dailyRibavirin (RBV): GT1, given weight-based and divided bid(1000 mg/day if < 75 kg or 1200 mg/day if ≥ 75 kg)Ribavirin (RBV): GT 2,3(800 mg/day) N =14 Source: Sulkowski MS, et al. N Engl J Med. 2014;370:211-21.

  5. Daclatasvir + Sofosbuvir +/- Ribavirin for HCV GT 1-3A1444-040 Treatment-Naïve 24 Week Rx: Results 0 12 24 36 Week n =16 Rx Naïve GT 2 or 3n = 44 SVR12 = 88% SOF × 7 days, then DCV + SOF n = 14 SVR12 = 93% DCV + SOF n = 14 SVR12 = 86% DCV + SOF + RBV n =15 Rx Naïve GT 1a/1bn = 44 SVR12 = 100% SOF × 7 days, then DCV + SOF n = 14 SVR12 = 100% DCV + SOF n = 15 DCV + SOF + RBV SVR12 = 100% Drug DosingDaclatasvir (DCV): 60 mg once dailySofosbuvir (SOF): 400 mg once dailyRibavirin (RBV): GT 1, given weight-based and divided bid(1000 mg/day if < 75 kg or 1200 mg/day if ≥ 75 kg)Ribavirin (RBV): GT 2,3(800 mg/day) N =14 Source: Sulkowski MS, et al. N Engl J Med. 2014;370:211-21.

  6. Daclatasvir + Sofosbuvir +/- Ribavirin for HCV GT 1-3A1444-040 Treatment-Naïve 24 Week Rx: Results Treatment-Naïve: GT 2 or 3 Treatment-Naïve: GT 1a or 1b DCV = daclatasvir; SOF = sofosbuvir; RBV = ribavirin Source: Sulkowski MS, et al. N Engl J Med. 2014;370:211-21.

  7. Daclatasvir + Sofosbuvir +/- Ribavirin for HCV GT 1-3GT1 Treatment-Naïve & Experienced 12 Week Rx: Results 0 12 24 Week Rx Naïve GT 1a/1bn = 82 n = 41 SVR12 = 100% DCV + SOF n = 41 SVR12 = 100% DCV + SOF + RBV Rx Experienced GT 1a/1bPrior Boceprevir- or Telaprevir failuren = 41 n = 21 SVR12 = 90% DCV + SOF n = 20 SVR12 = 95% DCV + SOF + RBV Drug DosingDaclatasvir (DCV): 60 mg once dailySofosbuvir (SOF): 400 mg once dailyRibavirin (RBV): GT1, given weight-based and divided bid(1000 mg/day if < 75 kg or 1200 mg/day if ≥ 75 kg)Ribavirin (RBV): GT 2,3(800 mg/day) N =14 Source: Sulkowski MS, et al. N Engl J Med. 2014;370:211-21.

  8. Daclatasvir + Sofosbuvir +/- Ribavirin for HCV GT 1-3GT1 Treatment-Naïve & Experienced 12 Week Rx: Results Treatment-Naïve: GT 1a or 1b Treatment-Experienced: GT 1a or 1b DCV = daclatasvir; SOF = sofosbuvir; RBV = ribavirin Source: Sulkowski MS, et al. N Engl J Med. 2014;370:211-21.

  9. Daclatasvir + Sofosbuvir +/- Ribavirin for HCV GT 1-3Trial: Conclusions Source: Sulkowski MS, et al. N Engl J Med. 2014;370:211-21.

  10. 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