Hepatitis web study Hepatitis web study Simeprevir + Sofosbuvir +/- Ribavirin in Genotype 1 COSMOS Trial Phase 2a, Treatment Naïve and Treatment Experienced.

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Presentation transcript:

Hepatitis web study Hepatitis web study Simeprevir + Sofosbuvir +/- Ribavirin in Genotype 1 COSMOS Trial Phase 2a, Treatment Naïve and Treatment Experienced Treatment Naïve and Treatment Experienced Lawitz E, et al. Lancet. 2014;384;

Hepatitis web study Source: Lawitz E, et al. Lancet. 2014;384; Simeprevir + Sofosbuvir +/- Ribavirin for HCV GT 1 COSMOS Trial: Study Features

Hepatitis web study Source: Lawitz E, et al. Lancet. 2014;384; Simeprevir + Sofosbuvir +/- Ribavirin for HCV GT 1 COSMOS Trial: Baseline Characteristic Baseline Characteristic (n = 167) Cohorts 1 and 2 Median Age, years (range)57 (27-70) Male, %64 White, %81 Median Body Mass Index (BMI)28 HCV genotype1a= 78%; 1b = 22% IL28B non-CC genotype, (%)86% Mean baseline HCV RNA, log 10 IU/ml6.6 Metavir ScoreF01= 20%; F2=28%; F3 = 28%; F4=25% Previous HCV treatment No response (%) Treatment-naïve (%) 76% 24%

Hepatitis web study Simeprevir + Sofosbuvir +/- Ribavirin for HCV GT 1 COSMOS Trial: Design for Cohort 1 Cohort 1: Prior Nonresponders; Metavir Scores F0-F2 Source: Lawitz E, et al. Lancet. 2014;384; SOF + SMV + RBV SOF + SMV N = 14 SOF + SMV N = 27 N = 15 N = 24 Drug Dosing SOF= Sofosbuvir: 400 mg once daily SMP =Simeprevir: 150 mg once daily RBV = Ribavirin (weight-based and divided bid): 1000 mg/day if < 75 kg or 1200 mg/day if ≥ 75 kg Week 12 SVR12

Hepatitis web study Simeprevir + Sofosbuvir +/- Ribavirin for HCV GT 1 COSMOS Trial: Results for Cohort 1 COSMOS (Cohort 1): SVR 12 by Regimen Source: Lawitz E, et al. Lancet. 2014;384; SOF = sofosbuvir; SMV = simeprevir; RBV = ribavirin 19/2414/1526/2713/14 24-Week Treatment12-Week Treatment

Hepatitis web study Simeprevir + Sofosbuvir +/- Ribavirin for HCV GT 1 COSMOS Trial: Design for Cohort 2 Cohort 2: Treatment Naïve & Prior Nonresponders; Metavir Scores F3-F4 Source: Lawitz E, et al. Lancet. 2014;384; SOF + SMV + RBV SVR12 SOF + SMV N = 14 Drug Dosing Sofosbuvir: 400 mg once daily Simeprevir: 150 mg once daily Ribavirin (weight-based and divided bid): 1000 mg/day if < 75 kg or 1200 mg/day if ≥ 75 kg SOF + SMV N = 27 N = 16 N = 30 SVR Week 12

Hepatitis web study Simeprevir + Sofosbuvir +/- Ribavirin for HCV GT 1 COSMOS Trial: Results COSMOS (Cohort 2 with F3-F4 Fibrosis): SVR12 by Regimen Source: Lawitz E, et al. Lancet. 2014;384; SOF = sofosbuvir; SMV = simeprevir; RBV = ribavirin 28/3016/1625/2713/14 24-Week Treatment12-Week Treatment

Hepatitis web study Simeprevir + Sofosbuvir +/- Ribavirin for HCV GT 1 COSMOS Trial: Results for Cohort 1 & 2 Cohort 1 & 2: SVR12 Source: Lawitz E, et al. Lancet. 2014;384; /24 24-Week Treatment12-Week Treatment 14/1526/2713/1428/3016/1625/2713/1472/8082/87 Overall

Hepatitis web study Simeprevir + Sofosbuvir +/- Ribavirin for HCV GT 1 COSMOS Trial: Results for Cohort 1 & 2 Cohort 1 & 2: SVR12 (Non-VR excluded analysis*) Source: Lawitz E, et al. Lancet. 2014;384; *Non-VR excluded analysis = SVR12 excludes early discontinuation due to non-virologic reasons or missing data at SVR12 time point 19/2013/1326/2713/1428/2815/1525/2713/1471/7481/84 24-Week Treatment12-Week TreatmentOverall

Hepatitis web study Simeprevir + Sofosbuvir +/- Ribavirin for HCV GT 1 COSMOS Trial: Results for Cohort 1 & 2 Impact of Q80K on SVR in Patients with GT1 Source: Lawitz E, et al. Lancet. 2014;384; *Q80K = Gln80Lys 17/1830/3164/6838/4055/6218/1926/2735/37119/13068/7225/3151/58

Hepatitis web study Source: Lawitz E, et al. Lancet. 2014;384; Simeprevir + Sofosbuvir +/- Ribavirin for HCV GT 1 COSMOS Trial: Interpretation Interpretation: “Combined simeprevir and sofosbuvir was efficacious and well tolerated.”

Hepatitis web study Hepatitis web study This slide deck is from the University of Washington’s Hepatitis C Online and Hepatitis Web Study projects. Hepatitis C Online Hepatitis Web Study Funded by a grant from the Centers for Disease Control and Prevention. This slide deck is from the University of Washington’s Hepatitis C Online and Hepatitis Web Study projects. Hepatitis C Online Hepatitis Web Study Funded by a grant from the Centers for Disease Control and Prevention.