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. Hepatology Oct 16. [Epub ahead of print].

Hepatitis web study Source: Lawitz E, et al. Hepatology Oct 16. [Epub ahead of print]. Sofosbuvir + PEG + RBV in Treatment-Experienced HCV GT 2 or 3 LONESTAR-2 Trial: Features

Hepatitis web study Source: Lawitz E, et al. Hepatology Oct 16. [Epub ahead of print]. 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. Hepatology Oct 16. [Epub ahead of print]. Sofosbuvir + PEG + RBV in Treatment-Experienced HCV GT 2 or 3 LONESTAR-2 Trial: Design Sofosbuvir + Peginterferon + Ribavirin N = 47 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 Week 12 SVR12

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. Hepatology Oct 16. [Epub ahead of print]. 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. Hepatology Oct 16. [Epub ahead of print]. 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. Hepatology Oct 16. [Epub ahead of print]. 9/913/1410/12

Hepatitis web study Source: Lawitz E, et al. Hepatology Oct 16. [Epub ahead of print]. 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 Source: Gane EJ, et al. N Engl J Med. 2013;368: Sofosbuvir + PEG + RBV in Treatment-Experienced HCV GT 2 or 3 LONESTAR-2 Trial: Conclusion Conclusions: “In treatment-experienced patients with HCV genotypes 2 and 3, 12-week administration of sofosbuvir + peginterferon + ribavirin provided high SVR rates, irrespective of cirrhosis status. No safety concerns were identified.”

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.