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European Regulators Approve Daclatasvir for Hepatitis C

The European Medicines Agency, which handles regulatory approval for 28 countries of the European Union, this week approved Bristol-Myers Squibb's hepatitis C virus NS5A inhibitor daclatasvir (Daklinza) for use in combination therapy for HCV genotypes 1, 2, 3, and 4.

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Achillion NS5A Inhibitor + Sofosbuvir Shows High Early Cure Rate

An interferon-free dual combination of Achillion's hepatitis C virus NS5A inhibitor ACH-3012 plus Gilead Science's HCV polymerase inhibitor sofosbuvir (Sovaldi) taken for 8 weeks led to sustained virological response at 4 weeks post-treatment for people with HCV genotype 1 in a Phase 2 study, according to a company announcement.

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Studies Show High Cure Rates for Interferon-free Hepatitis C Treatment

An all-oral combination of daclatasvir (Daklinza) plus asunaprevir led to sustained virological response (SVR) in 82%-90% of treatment-naive and previously treated people with hepatitis C virus genotype 1b, while a regimen of sofosbuvir (Sovaldi) plus simeprevir (Olysio) cured 92%-94% of hepatitis C patients with or without cirrhosis, according to findings from a pair of clinical trials reported in the July 28 advance online edition of The Lancet.

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Vertex to Discontinue Sale of Telaprevir (Incivek) for Hepatitis C

Vertex Pharmaceuticals announced last week that it will stop selling its HCV protease inhibitor telaprevir (Incivek or Incivo) as of October 16, 2014. While the first generation direct-acting antivirals are more effective than pegylated interferon plus ribavirin alone, they are no match for newer drugs such as Gilead Sciences' sofosbuvir (Sovaldi) or AbbVie's forthcoming "3D" regimen in terms of efficacy or tolerability.

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New Hepatitis C Guidelines: Who Should Be Treated and When?

Everyone with chronic hepatitis C could potentially benefit from treatment with new direct-acting antivirals, but when resources are limited, people with advanced liver disease, those at greatest risk for complications, and those most likely to transmit HCV should be treated most urgently, according to new guidelines released this week from AASLD, IDSA, and IAS-USA.

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