Hepatitis web study Hepatitis web study Hepatitis web study Hepatitis web study Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir + RBV in Liver Transplant.

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Presentation transcript:

Hepatitis web study Hepatitis web study Hepatitis web study Hepatitis web study Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir + RBV in Liver Transplant Recipients with Recurrent HCV GT1 CORAL-I Phase 2 Treatment Naïve and Treatment Experienced Kwo PY, et al. N Engl J Med. 2014;371: Liver Transplantation

Hepatitis web study Source: Kwo PY, et al. N Engl J Med. 2014;371: D + RBV in Liver Transplant Recipients with Recurrent HCV GT1 CORAL-I Trial: Study Design

Hepatitis web study Source: Kwo PY, et al. N Engl J Med. 2014;371: D + RBV in Liver Transplant Recipients with Recurrent HCV GT1 CORAL-I Trial: Regimen N = 34 3D + Ribavirin SVR12 Week D = Ombitasvir-Paritaprevir-Ritonavir + Dasabuvir Drug Dosing Ombitasvir-Paritaprevir-Ritonavir- (25/150/100 mg once daily) + Dasabuvir: 250 mg twice daily Ribavirin (RBV): dosing managed per investigator discretion; most patients received mg/day

Hepatitis web study Source: Kwo PY, et al. N Engl J Med. 2014;371: D + RBV in Liver Transplant Recipients with Recurrent HCV GT1 CORAL-I Trial: Baseline Characteristics Baseline Characteristic3D + Ribavirin (n=34) Age (years), Mean59.6 Male sex–no. (%)27 (79) Race–no. (%) White Black Multiple 29 (85) 4 (12) 1 (3) Body Mass Index (kg/m 2 ) Mean29.7 HCV genotype–no. (%) 1a 1b 29 (85) 5 (15) IL28B, non-CC genotype–no. (%)26 (76) HCV RNA, log 10 IU/ml6.6 Fibrosis stage (%) F0 F1 F2 6 (18) 13 (38) 15 (44) 3D = Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir; RBV = ribavirin

Hepatitis web study Source: Kwo PY, et al. N Engl J Med. 2014;371: D + RBV in Liver Transplant Recipients with Recurrent HCV GT1 CORAL-I Trial: Results 34/34 On Treatment 33/34 After Treatment

Hepatitis web study Source: Kwo PY, et al. N Engl J Med. 2014;371: D + RBV in Liver Transplant Recipients with Recurrent HCV GT1 CORAL-I Trial: Adverse Events Adverse Event Occurring in > 15% of the 34 Patients Receiving 3D + RBV EventN (%) Any adverse event33 (97) Fatigue17 (50) Headache15 (44) Cough11 (32) Anemia10 (29) Diarrhea9 (26) Insomnia9 (26) Asthenia8 (24) Nausea8 (24) Muscle spasms7 (21) Rash7 (21) Back pain6 (18) Dizziness6 (18) Peripheral edema6 (18 Rhinorrhea6 (18) 3D = Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir; RBV = ribavirin

Hepatitis web study Source: Kwo PY, et al. N Engl J Med. 2014;371: D + RBV in Liver Transplant Recipients with Recurrent HCV GT1 CORAL-I Trial: Conclusions Conclusions: “Treatment with the multitargeted regimen of ombitasvir- ABT-450/r and dasabuvir with ribavirin was associated with a low rate of serious adverse events and a high rate of sustained virologic response among liver-transplant recipients with recurrent HCV genotype 1 infection, a historically difficult-to-treat population.” Note: ABT-450/r = Paritaprevir-Ritonavir

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 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.