Hepatitis web study Hepatitis web study Ombitasvir + Paritaprevir + Ritonavir +/- Ribavirin in HCV GT4 PEARL-I Phase 2b Treatment Naïve and Treatment Experienced.

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Phase 3b Treatment-Naive

Phase 3 Treatment-Naïve and Treatment-Experienced

Ombitasvir + Paritaprevir + Ritonavir +/- Ribavirin in HCV GT4 PEARL-I

Phase 3 Treatment-Naïve and Treatment-Experienced

Ledipasvir-Sofosbuvir +/- Ribavirin in HCV Genotype 1 ION-2

Phase 2 Treatment Naïve and Treatment Experienced

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Phase 3 Treatment Naïve and Treatment Experienced HIV Coinfection

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Presentation transcript:

Hepatitis web study Hepatitis web study Ombitasvir + Paritaprevir + Ritonavir +/- Ribavirin in HCV GT4 PEARL-I Phase 2b Treatment Naïve and Treatment Experienced Hézode C, et al. Lancet March 30. [Epub ahead of print]

Hepatitis web study Source: Hézode C, et al. Lancet March 30. [Epub ahead of print] Ombitasvir + Paritaprevir + Ritonavir +/- RBV in HCV GT4 PEARL-I: Study Design

Hepatitis web study Source: Hézode C, et al. Lancet March 30. [Epub ahead of print] Ombitasvir + Paritaprevir + Ritonavir +/- RBV in HCV GT4 PEARL-I: Regimens n = 44 Ombitasvir + Paritaprevir + Ritonavir SVR12 n = 42 Ombitasvir + Paritaprevir + Ritonavir + Ribavirin SVR12 Week Drug Dosing Ombitasvir (25 mg once daily), Paritaprevir (150 mg once daily), Ritonavir (100 mg once daily) Ribavirin (RBV): weight-based and divided bid (1000 mg/day if < 75kg or 1200 mg/day if ≥ 75kg) HCV Treatment Naïve GT4 HCV Treatment Experienced GT4 n = 49 Ombitasvir + Paritaprevir + Ritonavir + Ribavirin SVR12

Hepatitis web study Source: Hézode C, et al. Lancet March 30. [Epub ahead of print] Ombitasvir + Paritaprevir + Ritonavir +/- RBV in HCV GT4 PEARL-I: Baseline Characteristics Baseline Characteristic Treatment NaiveTreatment Experienced 3D (n=44) 3D + RBV (n=42) 3D + RBV (n=49) Age, years BMI kg/m IL28B CC CT TT 27% 55% 18% 26% 62% 12% 12% 65% 22% HCV RNA log 10 IU/ml HCV RNA ≥ 800,000 IU/ml61%71%76% Fibrosis Stage F0-F1 F2 F3 86% 9% 15% 79% 14% 7% 67% 22% 10% 3D = Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir; RBV = Ribavirin

Hepatitis web study Ombitasvir + Paritaprevir + Ritonavir +/- RBV in HCV GT4 PEARL-I: Results PEARL-I: SVR 12 Rates* Source: Hézode C, et al. Lancet March 30. [Epub ahead of print] 40/44 3D = Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir; RBV = ribavirin Treatment-NaiveTreatment-Experienced 42/4249/49

Hepatitis web study Source: Hézode C, et al. Lancet March 30. [Epub ahead of print] Ombitasvir + Paritaprevir + Ritonavir +/- RBV in HCV GT4 PEARL-I: Adverse Events Baseline Characteristic Treatment NaiveTreatment Experienced 3D (n=44) 3D + RBV (n=42) 3D + RBV (n=49) Any adverse event34 (77%)37 (88%)43 (88%) Any serious adverse event1 (2%)00 Adverse event leading to drug D/C000 Asthenia11 (25%)10 (24%)16 (33%) Diarrhea2 (5%)6 (14%)3 (6%) Fatigue3 (7%)5 (12%)9 (18%) Headache13 (30%)14 (33%)14 (29%) Insomnia2 (5%)4 (10%)8 (16%) Irritability3 (7%)6 (14%)2 (4%) Myalgias005 (10%) Nasopharyngitis2 (5%) 6 (12%) Nausea4 (9%)7 (17%)6 (12%) Pruritis2 (5%)1 (2%)5 (10%) 3D = Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir; RBV = Ribavirin; D/C = discontinuation

Hepatitis web study Source: Hézode C, et al. Lancet March 30. [Epub ahead of print] Ombitasvir + Paritaprevir + Ritonavir +/- RBV in HCV GT4 PEARL-I: Interpretation Interpretation: “An interferon-free regimen of ombitasvir plus paritaprevir plus ritonavir with or without ribavirin achieved high sustained virological response rates at 12 weeks after the end of treatment and was generally well tolerated, with low rates of anaemia and treatment discontinuation in non-cirrhotic previously untreated and previously treated patients with HCV genotype 4 infection.”

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.