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Phase 2. HIV Coinfection. Treatment Naïve and Treatment Experienced. 3 D (Paritaprevir-Ritonavir-Ombitasvir + Dasabuvir) + RBV in GT1 TURQUOISE-I. Wyles D, et al. 65 th AASLD. 2014: Abstract 1939. 3D + Ribavirin for HCV -HIV Coinfection and GT1 TURQUOISE -I: Part 1 Study Design.

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3 d paritaprevir ritonavir ombitasvir dasabuvir rbv in gt1 turquoise i
Phase 2

HIV Coinfection

Treatment Naïve and Treatment Experienced

3D (Paritaprevir-Ritonavir-Ombitasvir+ Dasabuvir) + RBV in GT1 TURQUOISE-I

Wyles D, et al. 65th AASLD. 2014: Abstract 1939.

3d ribavirin for hcv hiv coinfection and gt1 turquoise i part 1 study design
3D + Ribavirin for HCV-HIV Coinfectionand GT1TURQUOISE-I: Part 1 Study Design

Source: Wyles D, et al. 65th AASLD. 2014: Abstract 1939.

3d ribavirin for hcv hiv coinfection and gt1 turquoise i part 1 study regimens
3D + Ribavirin for HCV-HIV Coinfectionand GT1TURQUOISE-I: Part 1 Study Regimens

0

12

24

36

Week

3D + Ribavirin

N = 31

SVR12

3D + Ribavirin

N = 32

SVR12

3D = Paritaprevir-Ritonavir-Ombitasvir + Dasabuvir

Drug Dosing3D = Paritaprevir-Ritonavir-Ombitasvir (150/100/25 mg once daily)+ Dasabuvir: 250 mg twice dailyRibavirin (RBV): weight-based and divided bid (1000 mg/day if < 75kg or 1200 mg/day if ≥ 75kg)

Source: Wyles D, et al. 65th AASLD. 2014: Abstract 1939.

3d ribavirin for hcv hiv coinfection and gt 1 turquoise i patient population
3D + Ribavirin for HCV-HIV Coinfectionand GT 1TURQUOISE-I: Patient Population

Source: Wyles D, et al. 65th AASLD. 2014: Abstract 1939.

3d ribavirin for hcv hiv coinfection and gt 1 turquoise i part 1 results
3D + Ribavirin for HCV-HIV Coinfectionand GT 1TURQUOISE-I: Part 1 Results

TURQUOISE-I: SVR Rates (to date)

29/31

30/32

29/31

29/32

3D = Paritaprevir-Ritonavir-Ombitasvir + Dasabuvir

Source: Wyles D, et al. 65th AASLD. 2014: Abstract 1939.

3d ribavirin for hcv hiv coinfection and gt 1 turquoise i part 1 results1
3D + Ribavirin for HCV-HIV Coinfectionand GT 1TURQUOISE-I: Part 1 Results

Details of Five Patients NOT Achieving SVR 12

  • One patient in 12-week arm withdrew consent prior to finishing treatment; had undetectable HCV RNA at week 10
  • One patient in 12-week arm had virologic relapse at week 4 post treatment; had new resistant HCV variants at 3 viral targets (D168V in NS3/4A, M28T in NS5A, and S556G in NS5B)
  • One patient in 24-week arm had virologic breakthrough during treatment; had new resistant HCV variants at 3 viral targets (R155K in NS3/4A, Q30R in NS5A, and S556G in NS5B)
  • Two patients in 24-week arm achieved early SVR but appeared to be reinfected with GT1a isolate distinct from baseline HCV isolate; both patients had engaged in high-risk sexual activity post treatment

29/31

30/32

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Source: Wyles D, et al. 65th AASLD. 2014: Abstract 1939.

slide7

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.