Hepatitis web study Hepatitis web study Sofosbuvir + Peginterferon + Ribavirin in Genotype 2 or 3 LONESTAR-2 Phase 2 Treatment Experienced Lawitz E, et.

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Presentation transcript:

Hepatitis web study Hepatitis web study Sofosbuvir + Peginterferon + Ribavirin in Genotype 2 or 3 LONESTAR-2 Phase 2 Treatment Experienced Lawitz E, et al. 64th AASLD; Washington, DC Abstract LB-4.

Hepatitis web study Source: Lawitz E, et al. 64th AASLD; Washington, DC Abstract LB-4. Sofosbuvir + PEG + RBV in Treatment-Experienced HCV GT 2 or 3 LONESTAR-2 Trial: Features

Hepatitis web study Source: Lawitz E, et al. 64th AASLD; Washington, DC Abstract LB-4. Sofosbuvir + PEG + RBV in Treatment-Experienced HCV GT 2 or 3 LONESTAR-2 Trial: Patient Demographics Baseline Characteristic SOF + PEG + RBV x 12 weeks (n = 47) Age, mean (range)56 (39-72) Male, n (%)32 (68) White, n (%)45 (96) Hispanic, n (%)21 (45) Mean Body Mass Index (BMI) kg/m 2 (range)31 (21-53) IL28B CC, n (%)17 (36) HCV GT324 (51) Mean baseline HCV RNA, log 10 IU/ml (range)6.2 ( ) Cirrhosis, %26 (55) Prior Relapse / virologic breakthrough40 (85)

Hepatitis web study Source: Lawitz E, et al. 64th AASLD; Washington, DC Abstract LB-4. Sofosbuvir + PEG + RBV in Treatment-Experienced HCV GT 2 or 3 LONESTAR-2 Trial: Design 24 Week 012 Sofosbuvir + Peginterferon + Ribavirin N = 47 SVR12 Drug Dosing Sofosbuvir: 400 mg once daily Peginterferon alfa-2a: 180 µg once weekly Ribavirin (weight-based and in 2 divided doses): 1000 mg/day if < 75 kg or 1200 mg/day if ≥ 75 kg GT 2 or 3

Hepatitis web study Sofosbuvir + PEG + RBV in Treatment-Experienced HCV GT 2 or 3 LONESTAR-2 Trial: Results SVR12 in Treatment-Experienced by HCV Genotype Source: Lawitz E, et al. 64th AASLD; Washington, DC Abstract LB-4. 42/4722/2320/24

Hepatitis web study Sofosbuvir + PEG + RBV in Treatment-Experienced HCV GT 2 or 3 LONESTAR-2 Trial: Results SVR12 in Treatment-Experienced by HCV Genotype Source: Lawitz E, et al. 64th AASLD; Washington, DC Abstract LB-4. 42/4722/2320/24 Five Treatment Failures - 1 patient with GT2 lost to follow-up - 2 patients with GT3 with virologic relapse - 2 patients with GT3 lost to follow-up

Hepatitis web study Sofosbuvir + PEG + RBV in Treatment-Experienced HCV GT 2 or 3 LONESTAR-2 Trial: Results LONESTAR-2 Trial: SVR12 by Cirrhosis Status Source: Lawitz E, et al. 64th AASLD; Washington, DC Abstract LB-4. 9/913/1410/12

Hepatitis web study Source: Lawitz E, et al. 64th AASLD; Washington, DC Abstract LB-4. Sofosbuvir + PEG + RBV in Treatment-Experienced HCV GT 2 or 3 LONESTAR-2 Trial: Adverse Events LONESTAR-2: Adverse Events in ≥ 15% of Patients Preferred Term, n (%) SOF + PEG + RBV x 12 weeks (n = 47) Any Adverse Event45 (96) Flu-like Symptoms26 (55) Fatigue15 (32) Anemia14 (30) Neutropenia11 (23) Nausea8 (17) Headache7 (15) Rash7 (15) Thrombocytopenia7 (15)

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.