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Simeprevir + Sofosbuvir +/- Ribavirin in Genotype 1 COSMOS Trial

Phase 2a, Treatment Naïve and Treatment Experienced. Treatment Naïve and Treatment Experienced. Simeprevir + Sofosbuvir +/- Ribavirin in Genotype 1 COSMOS Trial. Lawitz E , et al. Lancet. 2014;July 28 [ Epub ahead of print].

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Simeprevir + Sofosbuvir +/- Ribavirin in Genotype 1 COSMOS Trial

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  1. Phase 2a, Treatment Naïve and Treatment Experienced Treatment Naïve and Treatment Experienced Simeprevir+ Sofosbuvir +/- Ribavirin in Genotype 1COSMOS Trial LawitzE, et al. Lancet. 2014;July 28 [Epub ahead of print].

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

  3. Simeprevir + Sofosbuvir +/- Ribavirin for HCV GT 1COSMOS Trial: Baseline Characteristic Source: Lawitz E, et al. Lancet. 2014;July 28 [Epub ahead of print]

  4. Simeprevir + Sofosbuvir +/- Ribavirin for HCV GT 1COSMOS Trial: Design for Cohort 1 Cohort 1: Prior Nonresponders; MetavirScores F0-F2 0 12 24 36 Week SOF + SMV + RBV N = 24 SVR12 SOF + SMV SVR12 N = 15 SOF + SMV + RBV SVR12 N = 27 SOF + SMV N = 14 SVR12 Drug DosingSOF= Sofosbuvir: 400 mg once dailySMP =Simeprevir: 150 mg once dailyRBV = Ribavirin (weight-based and divided bid): 1000 mg/day if < 75 kg or 1200 mg/day if ≥ 75 kg Source: Lawitz E, et al. Lancet. 2014;July 28 [Epub ahead of print]

  5. Simeprevir + Sofosbuvir +/- Ribavirin for HCV GT 1COSMOS Trial: Results for Cohort 1 COSMOS (Cohort 1): SVR 12 by Regimen 19/24 14/15 26/27 13/14 24-Week Treatment 12-Week Treatment SOF = sofosbuvir; SMV = simeprevir; RBV = ribavirin Source: Lawitz E, et al. Lancet. 2014;July 28 [Epub ahead of print]

  6. Simeprevir + Sofosbuvir +/- Ribavirin for HCV GT 1COSMOS Trial: Design for Cohort 2 Cohort 2: Treatment Naïve & Prior Nonresponders; MetavirScores F3-F4 0 12 24 36 Week SOF + SMV + RBV N = 30 SVR12 SOF + SMV SVR12 N = 16 SOF + SMV + RBV SVR12 N = 27 SOF + SMV N = 14 SVR12 Drug DosingSofosbuvir: 400 mg once dailySimeprevir: 150 mg once dailyRibavirin (weight-based and divided bid): 1000 mg/day if < 75 kg or 1200 mg/day if ≥ 75 kg Source: Lawitz E, et al. Lancet. 2014;July 28 [Epub ahead of print]

  7. Simeprevir + Sofosbuvir +/- Ribavirin for HCV GT 1COSMOS Trial: Results COSMOS (Cohort 2 with F3-F4 Fibrosis): SVR12 by Regimen 28/30 16/16 25/27 13/14 24-Week Treatment 12-Week Treatment SOF = sofosbuvir; SMV = simeprevir; RBV = ribavirin Source: Lawitz E, et al. Lancet. 2014;July 28 [Epub ahead of print]

  8. Simeprevir + Sofosbuvir +/- Ribavirin for HCV GT 1COSMOS Trial: Results for Cohort 1 & 2 Cohort 1 & 2: SVR12 19/24 28/30 14/15 16/16 26/27 25/27 13/14 13/14 72/80 82/87 24-Week Treatment 12-Week Treatment Overall Source: Lawitz E, et al. Lancet. 2014;July 28 [Epub ahead of print]

  9. Simeprevir + Sofosbuvir +/- Ribavirin for HCV GT 1COSMOS Trial: Results for Cohort 1 & 2 Cohort 1 & 2: SVR12 (Non-VR excluded analysis*) 19/20 28/28 13/13 15/15 26/27 25/27 13/14 13/14 71/74 81/84 24-Week Treatment 12-Week Treatment Overall *Non-VR excluded analysis = SVR12 excludes early discontinuation due to non-virologic reasons or missing data at SVR12 time point Source: Lawitz E, et al. Lancet. 2014;July 28 [Epub ahead of print]

  10. Simeprevir + Sofosbuvir +/- Ribavirin for HCV GT 1COSMOS Trial: Results for Cohort 1 & 2 Impact of Q80K on SVR in Patients with GT1 17/18 55/62 25/31 30/31 18/19 64/68 26/27 38/40 35/37 119/130 51/58 68/72 *G80K = Gln80Lys Source: Lawitz E, et al. Lancet. 2014;July 28 [Epub ahead of print]

  11. Simeprevir + Sofosbuvir +/- Ribavirin for HCV GT 1COSMOS Trial: Interpretation Source: Sulkowski MS, et al. JAMA. 2014;312:353-61.

  12. Simeprevir + Sofosbuvir +/- Ribavirin for HCV GT 1COSMOS 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]

  13. 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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