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;July 28 [Epub ahead of print].

Hepatitis web study Source: Lawitz E, et al. Lancet. 2014;July 28 [Epub ahead of print] Simeprevir + Sofosbuvir +/- Ribavirin for HCV GT 1 COSMOS Trial: Study Features

Hepatitis web study Source: Lawitz E, et al. Lancet. 2014;July 28 [Epub ahead of print] 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;July 28 [Epub ahead of print] 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;July 28 [Epub ahead of print] 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;July 28 [Epub ahead of print] 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;July 28 [Epub ahead of print] 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;July 28 [Epub ahead of print] 19/24 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;July 28 [Epub ahead of print] *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;July 28 [Epub ahead of print] *G80K = Gln80Lys 17/1830/3164/6838/4055/6218/1926/2735/37119/13068/7225/3151/58

Hepatitis web study Source: Sulkowski MS, et al. JAMA. 2014;312: Simeprevir + Sofosbuvir +/- Ribavirin for HCV GT 1 COSMOS Trial: Interpretation Interpretation: “Combined simeprevir and sofosbuvir was efficacious and well tolerated.”

Hepatitis web study Simeprevir + Sofosbuvir +/- Ribavirin for HCV GT 1 COSMOS Trial: Key Points High Rates of SVR even in difficult to treat groups, including patients compensated cirrhosis and prior nonresponse to therapy Rapid virologic response (RVR) did not predict SVR 12 Addition of ribavirin did not clearly improve SVR rates Extending treatment to 24 weeks did not clearly improve SVR rates, except possibly in patients with prior relapse and advanced fibrosis Patients with baseline G80K (Gln80Lys) had high SVR rates, including those with compensated cirrhosis Ribavirin did not significantly impact SVR in patients with baseline G80K Regimen well tolerated: fatigue, headache, and nausea were most common side effect Phase 3 studies underway with simeprevir + sofosbuvir in OPTIMIST program Source: Lawitz E, et al. Lancet. 2014;July 28 [Epub ahead of print]

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.