Detail Sofosbuvir for previously untreated chronic hepatitis C infection (from The New England Journal of Medicine, 2013, 368 (20), 1878-1887) Bibliografi Author: Lawitz, Eric ; Mangia, Alessandra ; Wyles, David ; Rodriguez-Torres, Maribel ; Hassanein, Tarek ; Gordon, Stuart C. ; Schultz, Michael ; Davis, Mitchell N. ; Kayali, Zeid ; Reddy, K. Rajender ; Jacobson, Ira M. ; Kowdley, Kris V. ; Nyberg, Lisa ; Subramanian, G. Mani ; Hyland, Robert H. ; Arterburn, Sarah ; Jiang, Deyuan ; McNally, John ; Brainard, Diana ; Symonds, William T. ; McHutchison, John G. ; Sheikh, Aasim M. ; Younossi, Zobair ; Gane, Edward J. Topik: Hepatitis C; Sofosbuvir; Hepatitis - Drug Bahasa: (EN )     Penerbit: Massachusetts Medical Society     Tahun Terbit: 2013     Jenis: Article - diterbitkan di jurnal ilmiah internasional Fulltext: nejmoa1214853.pdf (400.93KB; 0 download) Abstract Background: In phase 2 trials, the nucleotide polymerase inhibitor sofosbuvir was effective in previously untreated patients with chronic hepatitis C virus (HCV) genotype 1, 2, or 3 infection. Methods: We conducted two phase 3 studies in previously untreated patients with HCV infection. In a single-group, open-label study, we administered a 12-week regimen of sofosbuvir plus peginterferon alfa-2a and ribavirin in 327 patients with HCV genotype 1, 4, 5, or 6 (of whom 98% had genotype 1 or 4). In a noninferiority trial, 499 patients with HCV genotype 2 or 3 infection were randomly assigned to receive sofosbuvir plus ribavirin for 12 weeks or peginterferon alfa-2a plus ribavirin for 24 weeks. In the two studies, the primary end point was a sustained virologic response at 12 weeks after the end of therapy. Results: In the single-group study, a sustained virologic response was reported in 90% of patients (95% confidence interval, 87 to 93). In the noninferiority trial, a sustained response was reported in 67% of patients in both the sofosbuvir–ribavirin group and the peginterferon–ribavirin group. Response rates in the sofosbuvir–ribavirin group were lower among patients with genotype 3 infection than among those with genotype 2 infection (56% vs. 97%). Adverse events (including fatigue, headache, nausea, and neutropenia) were less common with sofosbuvir than with peginterferon. Conclusions: In a single-group study of sofosbuvir combined with peginterferon–ribavirin, patients with predominantly genotype 1 or 4 HCV infection had a rate of sustained virologic response of 90% at 12 weeks. In a noninferiority trial, patients with genotype 2 or 3 infection who received either sofosbuvir or peginterferon with ribavirin had nearly identical rates of response (67%). Adverse events were less frequent with sofosbuvir than with peginterferon. [hepatitis - drug] Opini Anda Klik untuk menuliskan opini Anda tentang koleksi ini! Lihat Sejarah Pengadaan  Konversi Metadata   Kembali

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