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Hepatitis web study Hepatitis web study Hepatitis web study Hepatitis web study Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir +/- RBV in GT1 PEARL-III.

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Presentation on theme: "Hepatitis web study Hepatitis web study Hepatitis web study Hepatitis web study Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir +/- RBV in GT1 PEARL-III."— Presentation transcript:

1 Hepatitis web study Hepatitis web study Hepatitis web study Hepatitis web study Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir +/- RBV in GT1 PEARL-III and PEARL-IV Phase 3 Treatment Naïve Ferenci P, et al. N Engl J Med. 2014;370:1983-92.

2 Hepatitis web study Source: Ferenci P, et al. N Engl J Med. 2014;370:1983-92. Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir +/- RBV in GT1 PEARL-III and PEARL-IV: Study Design

3 Hepatitis web study Source: Ferenci P, et al. N Engl J Med. 2014;370:1983-92. Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir +/- RBV in GT1 PEARL-III and PEARL-IV: Study Regimens HCV Genotype 1a n = 100 3D + Ribavirin SVR12 n = 205 3D + Placebo SVR12 HCV Genotype 1b n = 210 3D+ Ribavirin SVR12 n = 209 3D + Placebo SVR12 Week 01224 3D = Ombitasvir-Paritaprevir-Ritonavir + Dasabuvir Drug Dosing 3D = Ombitasvir-Paritaprevir-Ritonavir (25/150/100 mg once daily) + Dasabuvir: 250 mg twice daily Ribavirin (RBV): weight-based and divided bid (1000 mg/day if < 75kg or 1200 mg/day if ≥ 75kg)

4 Hepatitis web study Source: Ferenci P, et al. N Engl J Med. 2014;370:1983-92. Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir +/- RBV in GT1 PEARL-III and PEARL-IV: Baseline Characteristics Baseline Characteristic Genotype 1aGenotype 1b 3D + RBV (n=100) 3D (n=205) 3D + RBV (n=210) 3D (n=209) Age, years51.651.448.449.2 Male sex (%)70.062.950.541.2 BMI kg/m 2 26.926.725.826.1 Race (%) White Black Other 86.0 10.0 4.0 83.4 12.7 3.9 94.3 4.8 1.0 94.2 4.8 1.0 IL28B CC (%)31.030.721.021.1 Metavir F3 (%)16.0%18.5%10.5%9.6% HCV RNA log 10 IU/ml6.646.536.296.33 3D = Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir; RBV = Ribavirin

5 Hepatitis web study Source: Ferenci P, et al. N Engl J Med. 2014;370:1983-92. Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir +/- RBV in GT1 PEARL-III and PEARL-IV: Results Genotype 1aGenotype 1b 3D = Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir RBV = Ribavirin 97/100185/205209/210207/209

6 Hepatitis web study Source: Ferenci P, et al. N Engl J Med. 2014;370:1983-92. Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir +/- RBV in GT1 PEARL-III and PEARL-IV: Adverse Events Event GT1aGT1b 3D + RBV (n=100) 3D ( n=205) 3D + RBV (n=210 ) 3D (n=209) Any adverse event %92.082.480.067 Any serious adverse event %3.00.51.9 Common adverse events: Headache %25.028.324.323.4 Fatigue %46.035.121.423.0 Pruritus %10.05.911.95.3 Nausea %21.013.711.04.3 Insomnia %17.07.89.03.3 Diarrhea %14.016.14.36.2 Laboratory abnormalities (%): Hemoglobin < 10 g/dl4.009.00 Total bilirubin > 3x ULN3.00.55.70.5 3D = Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir; RBV = Ribavirin

7 Hepatitis web study Source: Ferenci P, et al. N Engl J Med. 2014;370:1983-92. Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir +/- RBV in GT1 PEARL-III and PEARL-IV: Adverse Events Event GT1aGT1b 3D + RBV (n=100) 3D ( n=205) 3D + RBV (n=210 ) 3D (n=209) Any adverse event %92.082.480.067 Any serious adverse event %3.00.51.9 Common adverse events: Headache %25.028.324.323.4 Fatigue %46.035.121.423.0 Pruritus %10.05.911.95.3 Nausea %21.013.711.04.3 Insomnia %17.07.89.03.3 Diarrhea %14.016.14.36.2 Laboratory abnormalities (%): Hemoglobin < 10 g/dl4.009.00 Total bilirubin > 3x ULN3.00.55.70.5 3D = Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir; RBV = ribavirin

8 Hepatitis web study Source: Ferenci P, et al. N Engl J Med. 2014;370:1983-92. Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir +/- RBV in GT1 PEARL-III and PEARL-IV: Conclusions Conclusions: “Twelve weeks of treatment with ABT-450/r–ombitasvir and dasabuvir without ribavirin was associated with high rates of sustained virologic response among previously untreated patients with HCV genotype 1 infection. Rates of virologic failure were higher without ribavirin than with ribavirin among patients with genotype 1a infection but not among those with genotype 1b infection.” Note: ABT-450/r = Paritaprevir-Ritonavir

9 Hepatitis web study Hepatitis web study 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 www.hepatitisc.uw.edu www.hepatitisc.uw.edu Hepatitis Web Study http://depts.washington.edu/hepstudy/ http://depts.washington.edu/hepstudy/ 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 www.hepatitisc.uw.edu www.hepatitisc.uw.edu Hepatitis Web Study http://depts.washington.edu/hepstudy/ http://depts.washington.edu/hepstudy/ Funded by a grant from the Centers for Disease Control and Prevention.


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