Phase 3 Treatment Nave and Treatment Experienced HIV

Phase 3 Treatment Naïve and Treatment Experienced HIV Coinfection Simeprevir in HIV Coinfection, GT-1 C 212 Trial Dieterich D, et al. Clin Infect Dis. 2014; 59: 1579 -87. Hepatitis web study

Simeprevir + PEG + Ribavirin for HCV-HIV Coinfection Study C 212: Study Features C 212 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 - CD 4 ≥ 200 if on stable ARV therapy; CD 4 ≥ 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 CD 4 (cells/mm 3): 629 cells/mm 3 § Primary End-Points: Efficacy (SVR 12), safety, and impact on HIV Source: Dieterich D, et al. Clin Infect Dis. 2014; 59: 1579 -87. Hepatitis web study

Simeprevir + PEG + Ribavirin for HCV-HIV Coinfection Study C 212: Design Week 0 12 24 48 Simeprevir Treatment-Naïve or Prior Relapse Response Guided Therapy Peginterferon + Ribavirin Simeprevir Peginterferon + Ribavirin Partial Response or Null Response Simeprevir Peginterferon + Ribavirin Drug Dosing Simeprevir: 150 mg once daily Peginterferon alfa-2 a (PEG): 180 mcg/week Ribavirin (RBV) weight-based (in 2 divided doses): 1000 mg if < 75 kg or 1200 mg/day if ≥ 75 kg Source: Dieterich D, et al. Clin Infect Dis. 2014; 59: 1579 -87. Hepatitis web study

Simeprevir + PEG + Ribavirin for HCV-HIV Coinfection Study C 212: Results C 212: SVR 12 by Prior Treatment Status Patients (%) with SVR 12 100 87 80 74 79 70 57 60 40 20 0 78/106 42/53 13/15 7/10 16/28 Overall Treatment-Naïve Relapsers Partial Null Treatment-Experienced Source: Dieterich D, et al. Clin Infect Dis. 2014; 59: 1579 -87. Hepatitis web study

Simeprevir + PEG + Ribavirin for HCV-HIV Coinfection Study C 212: Results C 212: SVR 12 by GT 1 Subtype and Baseline NS 3 Q 80 K Polymorphism Patients (%) with SVR 12 100 89 80 71 67 72 60 40 20 0 16/18 62/88 20/30 42/58 GT 1 b GT 1 a with Q 80 K GT 1 a without Q 80 K Source: Dieterich D, et al. Clin Infect Dis. 2014; 59: 1579 -87. Hepatitis web study

Simeprevir + PEG + Ribavirin for HCV-HIV Coinfection Study C 212: Results C 212: SVR 12 by Fibrosis Stage and Prior History Patients (%) with SVR 12 100 80 100 METAVIR F 0 -F 2 89 METAVIR F 3 -F 4 80 78 67 64 60 57 57 60 50 40 20 0 36/45 14/22 Overall 24/27 4/7 Treatment-Naïve 7/9 2/2 Relapsers 1/2 2/3 Partial 4/7 6/10 Null Treatment-Experienced Source: Dieterich D, et al. Clin Infect Dis. 2014; 59: 1579 -87. Hepatitis web study

Simeprevir + PEG + Ribavirin for HCV-HIV Coinfection Study C 212: Results C 212: SVR 12 by IL 28 B Genotype 100 Patients (%) with SVR 12 96 100 80 60 100 80 80 71 70 68 CC CT TT 61 53 50 50 40 20 0/2 0 27/28 40/59 11/18 15/15 19/27 8/10 Overall Treatment-Naïve 7/7 6/6 0 Relapsers 1/1 5/7 1/2 Partial 4/5 10/19 2/4 Null Treatment-Experienced Source: Dieterich D, et al. Clin Infect Dis. 2014; 59: 1579 -87. Hepatitis web study

Simeprevir + PEG + Ribavirin for HCV-HIV Coinfection Study C 212: Conclusions: “Simeprevir was generally well tolerated with safety similar to that observed in HCV-monoinfected patients and high SVR 12 rates in HCV treatment-naive patients, prior relapsers, prior partial responders, and prior null responders with HIV-1 coinfection. ” Source: Dieterich D, et al. Clin Infect Dis. 2014; 59: 1579 -87. Hepatitis web study

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