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IDWeek 2014: Sofosbuvir/Ledipasvir Safe and Effective for Genotype 1 HCV

A single-tablet regimen containing the hepatitis C virus (HCV) nucleotide polymerase inhibitor sofosbuvir and the NS5A inhibitor ledipasvir -- the combination in Gilead Science's recently approved Harvoni pill -- was well-tolerated and cured 97% of patients with HCV genotype 1 in the Phase 3 ION trials, researchers reported at the IDWeek 2014 meeting last week in Philadelphia.

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Simeprevir as Effective, Better Tolerated than Telaprevir in HCV Triple Therapy

The recently approved next-generation hepatitis C virus (HCV) protease inhibitor simeprevir (Olysio) produced sustained virological response rates similar to those of telaprevir (Incivek or Incivo) when combined with pegylated interferon and ribavirin, but with fewer side effects, researchers reported at theViral Hepatitis Congress taking place this week in Frankfurt.

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BMS Withdraws FDA Application for Hepatitis C Drug Asunaprevir

Bristol-Myers Squibb unexpectedly announced this week that it will no longer seek U.S. Food and Drug Administration (FDA) approval for its experimental hepatitis C virus (HCV) protease inhibitor asunaprevir, despite promising results in clinical trials to date.

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FDA Approves Harvoni, Gilead's Sofosbuvir/Ledipasvir Combo Pill for Hepatitis C

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On October 10, the U.S. Food and Drug Administration (FDA) approved a new once-daily combination pill for the treatment of genotype 1 chronic hepatitis C containing Gilead Sciences' HCV nucleotide polymerase inhibitor sofosbuvir (Sovaldi) plus ledipasvir, the first approved HCV NS5A inhibitor.

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Sofosbuvir + Ribavirin To Be Studied in Children and Adolescents with Hepatitis C

A Phase 2 clinical trial is now underway to evaluate sofosbuvir (Sovaldi) plus ribavirin for children and adolescents, ages 3-17 years, with hepatitis C virus genotypes 2 or 3. Another study will follow to test the forthcoming sofosbuvir/ledipasir coformulation in pediatric patients.

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