Sofosbuvir for Previously Untreated Chronic Hepatitis C Infection

• Published in: The New England journal of medicine Vol. 368; no. 20; pp. 1878 - 1887
• Main Authors: 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
• Format: Journal Article
• Language: English
• Published: Waltham, MA Massachusetts Medical Society 16.05.2013
• Subjects: Adult; Aged; Antiviral Agents - adverse effects; Antiviral Agents - therapeutic use; Antiviral drugs; Biological and medical sciences; Chronic infection; Clinical trials; Drug dosages; Drug therapy; Drug Therapy, Combination; Fatigue; Female; General aspects; Genotype; Genotype & phenotype; Genotypes; Headache; Hepacivirus - genetics; Hepatitis; Hepatitis C; Hepatitis C, Chronic - drug therapy; Hepatitis C, Chronic - virology; Human viral diseases; Humans; Infectious diseases; Interferon-alpha - adverse effects; Interferon-alpha - therapeutic use; Liver Cirrhosis - virology; Logistic Models; Male; Medical sciences; Middle Aged; Nausea; Neutropenia; Polyethylene Glycols - adverse effects; Polyethylene Glycols - therapeutic use; Recombinant Proteins - adverse effects; Recombinant Proteins - therapeutic use; Ribavirin; Ribavirin - adverse effects; Ribavirin - therapeutic use; RNA, Viral - blood; Sofosbuvir; Uridine Monophosphate - adverse effects; Uridine Monophosphate - analogs & derivatives; Uridine Monophosphate - therapeutic use; Viral diseases; Viral hepatitis; Young Adult; United States > US; Infection; Medicine; Digestive diseases; Hepatic disease; Viral disease; Viral hepatitis C
• ISSN: 0028-4793; 1533-4406; 1533-4406
• DOI: 10.1056/NEJMoa1214853

In two studies of sofosbuvir for previously untreated HCV infection, patients with genotype 1, 4, 5, or 6 had a 90% rate of sustained virologic response in a single-group study. In a study of sofosbuvir–ribavirin versus peginterferon–ribavirin for patients with genotype 2 or 3, the response rate was 67% in each group. As many as 170 million persons are chronically infected with the hepatitis C virus (HCV) worldwide, and more than 350,000 die annually from liver disease caused by HCV. 1 , 2 Estimates of the number of persons in the United States who have chronic HCV infection range from 2.7 million to 5.2 million. 3 , 4 For previously untreated cases of HCV genotype 1 infection (representing more than 70% of all cases of chronic HCV infection in the United States), the current standard of care is 12 to 32 weeks of an oral protease inhibitor combined with 24 to 48 weeks of peginterferon alfa-2a . . .