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MALACHITE study : OBV/PTV/r + DSV + RBV versus telaprevir + PEG-IFN + RBV in genotype 1

MALACHITE study : OBV/PTV/r + DSV + RBV versus telaprevir + PEG-IFN + RBV in genotype 1. Randomisation Open-label. W12. W24. W48. Design. 18-65 years HCV genotype 1 HCV RNA > 10,000 IU/ml Naïve (MALACHITE-I) Failure to prior PEG-IFN + RBV (MALACHITE-II) No cirrhosis

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MALACHITE study : OBV/PTV/r + DSV + RBV versus telaprevir + PEG-IFN + RBV in genotype 1

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  1. MALACHITE study: OBV/PTV/r + DSV + RBV versus telaprevir + PEG-IFN + RBV in genotype 1 Randomisation Open-label W12 W24 W48 • Design 18-65 years HCV genotype 1 HCV RNA > 10,000 IU/ml Naïve (MALACHITE-I) Failure to prior PEG-IFN + RBV (MALACHITE-II) No cirrhosis No HBV or HIV co-infection GT1a naïve N = 69 * N = 34 GT1b naïve N = 84 * N = 83 * Randomisation wasstratified on IL28B (CC or non-CC) N = 41 Experienced N = 101 ** ** Randomisation was stratified on genotype (1a or 1b) and previous response to PEG-IFN + RBV (null response, partial response, relapse) N = 47 Dore G. J Hepatol 2016; 64:19-28 MALACHITE

  2. MALACHITE study: OBV/PTV/r + DSV + RBV versus telaprevir + PEG-IFN + RBV in genotype 1 • Treatment regimens • Co-formulated ombitasvir (OBV)/paritaprevir (PTV)/rironavir (r): 25/150/100 mg qd = 2 tablets • Dasabuvir (DSB) : 250 mg bid • TVR: 750 mg tid, 8h apart • PEG-IFNa-2a : 180 mg SC once weekly • RBV: 1000 or 1200 mg/day (bid dosing) according to body weight (< or ≥ 75 kg) • In TVR groups, additional 12 or 36 weeks of PEG-IFN+ RBV depended on virologic response at treatment W4-12 • Primary efficacy endpoint • MALACHITE-I: Non inferiority of OBV/PTV/r + DSB + RBV compared to TVR + PEG-IFN + RBV in genotype 1a and of OBV/PTV/r + DSB compared to TVR + PEG-IFN + RBV in genotype 1b: SVR12 (HCV RNA < 25 IU/ml) by intention to treat (lower margin of the 2-sided 95% CI for the difference with TVR = - 10.5%) • MALACHITE-II: % of patients achieving SVR12 between treatment arms using a logistic regression model with treatment arm, baseline log10 HCV RNA level, HCV subgenotype (1a, non-1a), and previous PEG-IFN + RBV treatment response (relapse, partial response, null response) Dore G. J Hepatol 2016; 64:19-28 MALACHITE

  3. MALACHITE study: OBV/PTV/r + DSV + RBV versus telaprevir + PEG-IFN + RBV in genotype 1 Baseline characteristics and patient disposition (MALACHITE-I, treatment-naïve) * Among the 75 patients in the TVR groups, 59 received 24 weeks of PEG-IFN + RBV, 16 received 48 weeks Dore G. J Hepatol 2016; 64:19-28 MALACHITE

  4. MALACHITE study: OBV/PTV/r + DSV + RBV versus telaprevir + PEG-IFN + RBV in genotype 1 Baseline characteristics and patient disposition (MALACHITE-II, Treatment-experienced) Dore G. J Hepatol 2016; 64:19-28 MALACHITE

  5. MALACHITE study: OBV/PTV/r + DSV + RBV versus telaprevir + PEG-IFN + RBV in genotype 1 SVR12 (HCV RNA < 25 IU/ml), % (95% CI) MALACHITE-I (treatment-naïve) MALACHITE-II(treatment-experienced) % 99 (97-100) 99 (97-100) 98 (94-100) 97 (93-100) OBV/PTV/r + DSV + RBV 100 82 (68-96) OBV/PTV/r + DSV 78 (66-91) TVR + PEG-IFN + RBV 80 66 (53-79) 60 Genotype 1a: non-inferiority of OBV/PTV/r + DSV + RBVto TVR + PEG-IFN + RBV Genotype 1b: non-inferiority and superiority of OBV/PTV/r + DSV and of OBV/PTV/r + DSV + RBV to TVR + PEG-IFN + RBV 40 20 N 69 34 84 83 41 101 47 0 Genotype 1a Genotype 1b All patients * These 3 patients were adherent. At the time of failure, detection of resistance variants at in NS3, NS5A, and/or NS5B that were not present at baseline ** Reinfection (Genotype 2a) *** Missing data or premature discontinuation Dore G. J Hepatol 2016; 64:19-28 MALACHITE

  6. MALACHITE study: OBV/PTV/r + DSV + RBV versus telaprevir + PEG-IFN + RBV in genotype 1 Adverse events * Hot flush and fatigue Dore G. J Hepatol 2016; 64:19-28 MALACHITE

  7. MALACHITE study: OBV/PTV/r + DSV + RBV versus telaprevir + PEG-IFN + RBV in genotype 1 Laboratory abnormalities, % Patient-reported outcomes • SF-36v2 self-administered questionnaire: overall, the difference between the 2 regimens in the changes from baseline in Mental Component Summary and Physical Component Summary throughout the treatment and post-treatment periods in both treatment-naïve and treatment-experienced patients favored the OBV/PTV/r + DSV + RBV regimen Dore G. J Hepatol 2016; 64:19-28 MALACHITE

  8. MALACHITE study: OBV/PTV/r + DSV + RBV versus telaprevir + PEG-IFN + RBV in genotype 1 • Summary • This is the first head-to-head study of an all-oral, DAA (OBV/PTV/r + DSV + RBV) and a PEG-IFN-containing (TVR + PEG-IFN + RBV) regimen that quantitatively compares efficacy and safety benefits in treatment-naïve and treatment-experienced HCV genotype 1-infected patients • SVR12 rate was numerically higher with OBV/PTV/r + DSV + RBV (97-99%) than with TVR + PEG-IFN + RBV (66-82%) regardless of subgenotypeor prior treatment status • Better tolerability of OBV/PTV/r + DSV +RBV • Higher improvement in mental and physical health in patients receiving OBV/PTV/r + DSV + RBV • Limitations • Exclusion of cirrhosis • Absence of black patients • Low number of experienced patients with genotype 1a Dore G. J Hepatol 2016; 64:19-28 MALACHITE

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