Detail Efficacy of sofosbuvir plus ribavirin with or without peginterferon-alfa in patients with hepatitis C virus genotype 3 infection and treatment-experiencer patients with cirrhosis and hepatitis C virus genotype 2 infection (from Gastroenterology 2015, 149, 1462-1470) Bibliografi Author: Foster, Graham R. ; Pianko, Stephen ; Brown, Ashley ; Forton, Daniel ; Nahass, Ronald G. ; George, Jacob ; Barnes, Eleanor ; Brainhard, Diana M. ; Massetto, Benedetta ; Lin, Ming ; Han, Bin ; McHutchison, John G. ; Subramanian, G. Mani ; Cooper, Curtis ; Agarwal, Kosh ; BOSON Study Group Topik: Hepatitis C Virus; BOSON; Nucleotide Analog; Peginterferon; Hepatitis - Drug new Bahasa: (EN )     Penerbit: AGA Institute     Tahun Terbit: 2015     Jenis: Article - diterbitkan di jurnal ilmiah internasional Fulltext: 1-s2.0-S0016508515010690.pdf (508.89KB; 0 download) Abstract BACKGROUND & AIMS: We conducted an open-label, randomized, phase 3 trial to determine the efficacy and safety of sofosbuvir and ribavirin, with and without peginterferon-alfa, in treatment-experienced patients with cirrhosis and hepatitis C virus (HCV) genotype 2 infection and treatment-naïve or treatment-experienced patients with HCV genotype 3 infection. METHODS: The study was conducted at 80 sites in Europe, North America, Australia, and New Zealand Patients were randomly assigned (1:1:1) to groups given sofosbuvir and ribavirin for 16 weeks (n ¼ 196); sofosbuvir and ribavirin for 24 weeks (n ¼ 199); or sofosbuvir, peginterferon-alfa, and ribavirin for 12 weeks (n ¼ 197). The primary end point was the percentage of patients with HCV RNA <15 IU/mL 12 weeks after stopping therapy (sustained virologic response [SVR12]). From October 2013 until April 2014, we enrolled and treated 592 patients—48 with genotype 2 HCV and compensated cirrhosis who had not achieved SVR with previous treatments and 544 with genotype 3 HCV (279 treatment-naïve and 265 previously treated). Overall, 219 patients (37%) had compensated cirrhosis. The last post-treatment week 12 patient visit was in January 2015. RESULTS: Rates of SVR12 among patients with genotype 2 HCV were 87% and 100%, for those receiving 16 and 24 weeks of sofosbuvir and ribavirin, respectively, and 94% for those receiving sofosbuvir, peginterferon, and ribavirin for 12 weeks. Rates of SVR12 among patients with genotype 3 HCV were 71% and 84% in those receiving 16 and 24 weeks of sofosbuvir and ribavirin, respectively, and 93%in those receiving sofosbuvir, peginterferon, and ribavirin. On-treatment virologic failure occurred in 3 patients with HCV genotype 3a receiving sofosbuvir and ribavirin for 24 weeks. Themost common adverse events were fatigue, headache, insomnia, and nausea. Overall, 1% of patients discontinued treatment due to adverse events. CONCLUSIONS: Among patients with genotype 3 HCV infection, including a large proportion of treatment-experienced patients with cirrhosis, the combination of sofosbuvir, peginterferon, and ribavirin for 12 weeks produces high rates of SVR. Treatmentexperienced patients with cirrhosis and genotype 2 HCV infection had high rates of SVR in all groups. [hepatitis - drug new] Opini Anda Klik untuk menuliskan opini Anda tentang koleksi ini! Lihat Sejarah Pengadaan  Konversi Metadata   Kembali

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