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Phase 3. Treatment Naïve and Treatment Experienced. Simeprevir in HIV Coinfection, GT-1 C212 Trial. Dieterich D , et al. 21 st CROI. 2014: Abstract 24. Simeprevir + PEG + Ribavirin for HCV-HIV Coinfection C212 Trial: Study Features. - PowerPoint PPT Presentation
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Hepatitisweb study
Hepatitisweb study
Simeprevir in HIV Coinfection, GT-1C212 Trial
Phase 3
Treatment Naïve and Treatment Experienced
Dieterich D, et al. Clin Infect Dis. 2014 Sep 5 [Epub ahead of print]
HIV Coinfection
Hepatitisweb studySource: Dieterich D, et al. Clin Infect Dis. 2014 Sep 5 [Epub ahead of print]
Simeprevir + PEG + Ribavirin for HCV-HIV CoinfectionStudy C212: Study Features
C212 Trial: Features Design: Open-label, phase 3, trial evaluating simeprevir + PEG + RBV in
HCV-HIV and GT 1 (treatment naïve and experienced) Setting: 39 sites in 7 countries Entry Criteria
- HIV coinfection; HCV genotype 1- Treatment naïve or treatment experienced- Group 1: HCV treatment-naïve or prior relapse- Group 2: Prior partial or null response or cirrhosis- CD4 ≥ 200 if on stable ARV therapy; CD4 ≥ 500 if no ARV therapy- Stable antiretroviral therapy = HIV RNA < 50 copies/ml > 8 weeks
Patient Characteristics- N = 106 HCV-HIV coinfected patients- Race: white (82%); black (14%)- Baseline Median CD4 (cells/mm3): 629 cells/mm3
Primary End-Points: Efficacy (SVR12), safety, and impact on HIV
Hepatitisweb studySource: Dieterich D, et al. Clin Infect Dis. 2014 Sep 5 [Epub ahead of print]
Simeprevir + PEG + Ribavirin for HCV-HIV CoinfectionStudy C212: Design
Simeprevir
Peginterferon + RibavirinTreatment-Naïveor
Prior Relapse Simeprevir
Peginterferon + Ribavirin
Simeprevir
Peginterferon + Ribavirin
Partial Responseor
Null Response
Response Guided Therapy
Drug DosingSimeprevir: 150 mg once dailyPeginterferon alfa-2a (PEG): 180 mcg/week Ribavirin (RBV) weight-based (in 2 divided doses): 1000 mg if < 75kg or 1200 mg/day if ≥ 75kg
Week 0 12 4824
Hepatitisweb study
Simeprevir + PEG + Ribavirin for HCV-HIV CoinfectionStudy C212: Results
C212: SVR12 by Prior Treatment Status
Source: Dieterich D, et al. Clin Infect Dis. 2014 Sep 5 [Epub ahead of print]
Overall Treatment-Naïve Relapsers Partial Null0
20
40
60
80
100
7479
87
70
57
Patie
nts
(%) w
ith S
VR12
Treatment-Experienced
78/106 42/53 13/15 7/10 16/28
Hepatitisweb study
Simeprevir + PEG + Ribavirin for HCV-HIV CoinfectionStudy C212: Results
C212: SVR12 by GT1 Subtype and Baseline NS3 Q80K Polymorphism
Source: Dieterich D, et al. Clin Infect Dis. 2014 Sep 5 [Epub ahead of print]
GT1b GT1a GT1a with Q80K GT1a without Q80K
0
20
40
60
80
10089
7167
72
Patie
nts
(%) w
ith S
VR12
16/18 62/88 20/30 42/58
Hepatitisweb study
Simeprevir + PEG + Ribavirin for HCV-HIV CoinfectionStudy C212: Results
C212: SVR12 by Fibrosis Stage and Prior History
Source: Dieterich D, et al. Clin Infect Dis. 2014 Sep 5 [Epub ahead of print]
Overall Treatment-Naïve Relapsers Partial Null0
20
40
60
80
100
80
89
78
5057
6457
100
6760
METAVIR F0-F2METAVIR F3-F4
Patie
nts
(%) w
ith S
VR12
Treatment-Experienced
36/45 14/22 24/27 4/7 7/9 2/2 1/2 2/3 4/7 6/10
Hepatitisweb study
Overall Treatment-Naïve Relapsers Partial Null0
20
40
60
80
10096
100 100 100
80
68 70
100
71
53
61
80
0
50 50
CCCTTT
Patie
nts
(%) w
ith S
VR12
Simeprevir + PEG + Ribavirin for HCV-HIV CoinfectionStudy C212: Results
C212: SVR12 by IL28B Genotype
Source: Dieterich D, et al. Clin Infect Dis. 2014 Sep 5 [Epub ahead of print]
Treatment-Experienced
27/28 40/59 11/18 15/15 19/27 8/10 7/7 6/6
0/2
1/1 5/7 1/2 4/5 10/19 2/4
Hepatitisweb studySource: Dieterich D, et al. Clin Infect Dis. 2014 Sep 5 [Epub ahead of print]
Simeprevir + PEG + Ribavirin for HCV-HIV CoinfectionStudy C212: Conclusions
Conclusions: “Simeprevir was generally well tolerated with safety similar to that observed in HCV-monoinfected patients and high SVR12 rates in HCV treatment-naive patients, prior relapsers, prior partial responders, and prior null responders with HIV-1 coinfection.”
Hepatitisweb study
Hepatitisweb study
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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