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Treatment regimens

M14-103 Study: ombitasvir / paritaprevir / ritonavir + dasabuvir + RBV for genotype 1 on opioid replacement therapy. Design. Open-label. W12. W24. 18-70 years HCV genotype 1 HCV RNA > 10,000 IU/ml Naïve or pre-treated with PEG-IFN + RBV No cirrhosis ≥ 6 months opioid replacement*

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Treatment regimens

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  1. M14-103 Study: ombitasvir/paritaprevir/ritonavir + dasabuvir + RBV for genotype 1 on opioid replacement therapy • Design Open-label W12 W24 18-70 years HCV genotype 1 HCV RNA > 10,000 IU/ml Naïve or pre-treated with PEG-IFN + RBV No cirrhosis ≥ 6 months opioid replacement* No HBV or HIV co-infection N = 38 SVR12 * Methadone or buprenorphine (± naloxone) • Treatment regimens • Co-formulated ombitasvir (OBV)/paritaprevir (PTV)/rironavir (r) : 25/150/100 mg QD = 2 tablets • Dasabuvir(DSV) : 250 mg BID • RBV : 1000 or 1200 mg/day (bid dosing) according to body weight (< or ≥ 75 kg) • Objective • Primary endpoint : SVR12 (HCV RNA < 25 IU/ml), with 95% CI • Intensive 24 hours steady-state PK analysis Lalezari J. J Hepatology2015;63:364-9 M14-103

  2. M14-103 Study: ombitasvir/paritaprevir/ritonavir + dasabuvir + RBV for genotype 1 on opioid replacement therapy Baseline characteristics and outcome No virologic breakthrough, no relapse Lalezari J. J Hepatology2015;63:364-9 M14-103

  3. M14-103 Study: ombitasvir/paritaprevir/ritonavir + dasabuvir + RBV for genotype 1 on opioid replacement therapy Adverse events, n (%) Lalezari J. J Hepatology2015;63:364-9 M14-103

  4. M14-103 Study: ombitasvir/paritaprevir/ritonavir + dasabuvir + RBV for genotype 1 on opioid replacement therapy Steady-stade pharmacokinetic parameters (N = 22) • The steady-state exposures for OBV, PTV, and RTV were comparable to exposures in phase I studies of adults receiving similar formulations of OBV/PTV/r + DSV without methadone or buprenorphine, while exposures of DSV and DSV M1 were slightly lower * Median (arithmetic mean ± SD) ; ** AUC24 for drugs qd, AUC12 for drugs BID Lalezari J. J Hepatology2015;63:364-9 M14-103

  5. M14-103 Study: ombitasvir/paritaprevir/ritonavir + dasabuvir + RBV for genotype 1 on opioid replacement therapy • Summary • The 3D + RBV regimen achieved an SVR12rate of 97.4% among these 38 genotype 1-infected patients receiving opioid replacement therapy • No viral breakthroughs or relapses were observed • The regimen was well tolerated, with low rate of discontinuation • Adverse events were generally mild • Drug-drug interactions did not impact HCV treatment or opioid maintenance • No patient required a change in the dosage of methadone or buprenorphine during study treatment • 12 weeks all-oral regimen of OBV/PTV/r + DSV + RBV is well-tolerated and may be an attractive treatment option for genotype 1 infected patients receiving opioid replacement therapy Lalezari J. J Hepatology2015;63:364-9 M14-103

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