Ledipasvir and Sofosbuvir for Previously Treated HCV Genotype 1 Infection

• Published in: The New England journal of medicine Vol. 370; no. 16; pp. 1483 - 1493
• Main Authors: Afdhal, Nezam, Reddy, K. Rajender, Nelson, David R, Lawitz, Eric, Gordon, Stuart C, Schiff, Eugene, Nahass, Ronald, Ghalib, Reem, Gitlin, Norman, Herring, Robert, Lalezari, Jacob, Younes, Ziad H, Pockros, Paul J, Di Bisceglie, Adrian M, Arora, Sanjeev, Subramanian, G. Mani, Zhu, Yanni, Dvory-Sobol, Hadas, Yang, Jenny C, Pang, Phillip S, Symonds, William T, McHutchison, John G, Muir, Andrew J, Sulkowski, Mark, Kwo, Paul
• Format: Journal Article
• Language: English
• Published: Waltham, MA Massachusetts Medical Society 17-04-2014
• Subjects: Adult; Aged; Antiviral Agents - adverse effects; Antiviral Agents - therapeutic use; Benzimidazoles - administration & dosage; Benzimidazoles - adverse effects; Benzimidazoles - therapeutic use; Biological and medical sciences; Cirrhosis; Drug Combinations; Drug therapy; Fatigue; FDA approval; Female; Fluorenes - administration & dosage; Fluorenes - adverse effects; Fluorenes - therapeutic use; 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; Infections; Infectious diseases; Interferon; Liver cirrhosis; Male; Medical sciences; Middle Aged; Nausea; Nucleotidyltransferases - antagonists & inhibitors; Patients; Proteinase inhibitors; Ribavirin; RNA-Dependent RNA Polymerase - antagonists & inhibitors; Sofosbuvir; Uridine Monophosphate - administration & dosage; Uridine Monophosphate - adverse effects; Uridine Monophosphate - analogs & derivatives; Uridine Monophosphate - therapeutic use; Viral diseases; Viral hepatitis; Viral Load; Viral Nonstructural Proteins - antagonists & inhibitors; Infection; Medicine; Microbiological investigation; Treatment; Typing; Viral disease; Digestive diseases; Hepatic disease; Genotype; Viral hepatitis C
• ISSN: 0028-4793; 1533-4406
• DOI: 10.1056/NEJMoa1316366

In this study in patients with HCV genotype 1 infection and prior treatment failure, those assigned to 12 weeks or 24 weeks of treatment with ledipasvir and sofosbuvir, with or without ribavirin, had high rates of sustained response (94 to 99% in all groups).
Among the estimated 170 million people in the world who have chronic hepatitis C virus (HCV) infection, approximately 60% have the genotype 1 strain of the virus.
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The treatment of patients infected with HCV genotype 1 is evolving rapidly.
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At the end of 2013, the Food and Drug Administration (FDA) approved two new direct-acting antiviral agents for the treatment of HCV infection: the nucleotide polymerase inhibitor sofosbuvir (Gilead Sciences) and the protease inhibitor simeprevir (Janssen Therapeutics).
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Among the regimens that have been approved by the FDA for patients with HCV genotype 1 infection who have not had a . . .