Sofosbuvir for Hepatitis C Genotype 2 or 3 in Patients without Treatment Options

作者：Ira M. Jacobson, Stuart C. Gordon, Kris V. Kowdley, Eric M. Yoshida, Maribel Rodriguez‐Torres, Mark Sulkowski, Mitchell L. Shiffman, Eric Lawitz, Gregory T. Everson, MICHAEL R. BENNETT, Eugene R. Schiff, M. Tarek Al-Assi, G. Mani Subramanian, Di An, Ming Lin, John J. Mcnally, Diana M. Brainard, William T. Symonds, John G. McHutchison, Keyur Patel, Jordan J. Feld, Stephen Pianko, David R. Nelson · 发表于：New England Journal of Medicine · 年份：2013 · DOI：10.1056/nejmoa1214854 · 被引用次数：1092 · 研究领域：Hepatitis C virus research、HIV-related health complications and treatments、Blood disorders and treatments

BACKGROUND: Patients chronically infected with hepatitis C virus (HCV) genotype 2 or 3 for whom treatment with peginterferon is not an option, or who have not had a response to prior interferon treatment, currently have no approved treatment options. In phase 2 trials, regimens including the oral nucleotide polymerase inhibitor sofosbuvir have shown efficacy in patients with HCV genotype 2 or 3 infection. METHODS: We conducted two randomized, phase 3 studies involving patients with chronic HCV genotype 2 or 3 infection. In one trial, patients for whom treatment with peginterferon was not an option received oral sofosbuvir and ribavirin (207 patients) or matching placebo (71) for 12 weeks. In a second trial, patients who had not had a response to prior interferon therapy received sofosbuvir and ribavirin for 12 weeks (103 patients) or 16 weeks (98). The primary end point was a sustained virologic response at 12 weeks after therapy. RESULTS: Among patients for whom treatment with peginterferon was not an option, the rate of a sustained virologic response was 78% (95% confidence interval [CI], 72 to 83) with sofosbuvir and ribavirin, as compared with 0% with placebo (P<0.001). Among previously treated patients, the rate of response was 50% with 12 weeks of treatment, as compared with 73% with 16 weeks of treatment (difference, -23 percentage points; 95% CI, -35 to -11; P<0.001). In both studies, response rates were lower among patients with genotype 3 infection than among those ...