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This site displays a prototype of a “Web 2.0” version of the daily Federal Register.It is not an official legal edition of the Federal Register, and does not replace the official print version or the official electronic version on GPO’s Daclatasvir has also been investigated as monotherapy in a double blind, placebo-controlled, sequential panel, multiple ascending dose study.3 Thirty patients with chronic geno-type 1 hepatitis C infection were randomised to receive a 14 day course of the drug, in once daily doses of 1, 10, 30, 60 or 100mg, 30mg twice a day, or placebo.There was no evidence of antiviral activity in the placebo group, but the mean maximum decline of 2.8 to 4.1 log IU/ml.Results from the trial indicate high , also in those who have failed treatment with these protease inhibitors.Many such patients have very advanced liver disease and are in urgent need of effective therapy in order to cease the progression of liver injury.
C genotype 1b infection who did not respond to standard therapy were given daclatasvir in once daily 60mg doses, plus another experimental drug, BMS-790052, which is an NSP 3 protease inhibitor, in initial twice-daily 600mg doses, later reduced to 200mg twice a day.2 Nine patients completed 24 weeks of treatment, with the 10th discontinuing after 10 weeks.The OFR/GPO partnership is committed to presenting accurate and reliable regulatory information on Federal with the objective of establishing the XML-based Federal Register as an ACFR-sanctioned publication in the future.While every effort has been made to ensure that the material on Federal is accurately displayed, consistent with the official SGML-based PDF version on govinfo.gov, those relying on it for legal research should verify their results against an official edition of the Federal Register.In addition to limited efficacy and substantial side effects such as neutropenia, haemo lytic anemia and severe depression, current antiviral therapies are also characterized by high cost. These include small molecule compounds targeting HCV nonstructural proteins including the HCV protease, polymerase and NS5A protein. HCV entry into target cells is a promising target for antiviral preventive and therapeutic strategies since it is essential for initiation, spread, and maintenance of infection (Timpe et al, Gut, 2008, 57: 1728-1737; Zeisel et al, Hepatology, 2008, 48: 299-307). Virol, 2007, 81 : 374- 383; Scarselli et al, EMBO J., 2002, 21 : 5017-5025), Occludin (Ploss et al, Nature, 2009, 457: 882-886) and Claudin-1 (CLDN1), an integral membrane protein and a component of tight-junction strands (Evans et al, Nature, 2007, 446: 801-805).To improve efficacy of standard of care (SOC), a large number of direct acting antivirals (DAAs) targeting viral polyprotein processing and replication have been developed (Hofmann et al, Nat. Although a marked improvement of antiviral response was observed when protease inhibitors were combined with SOC (Hofmann et al, Nat. Indeed, HCV initiates infection by attaching to molecules or receptors on the surface of hepatocytes. Daclatasvir (BMS-790052; EBP 883) is a first-in-class, highly-selective oral HCV NS5A inhibitor.
According to the World Health Organization, 3 to 4 million new infections occur each year. Liver Dis., 2008, 12: 661-674; Jacobson et al, Clin. Chronic HCV infection is the leading indication for liver transplantations (Seeff et al., Hepatology, 2002, 36: 1-2). No vaccine protecting against HCV is yet available.