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EASL 2014: Sofosbuvir + Ledipasvir Is Safe and Effective for Relapsers and Hard-to-Treat Hep C Patients

A coformulation of sofosbuvir and ledipasvir successfully treated a variety of difficult-to-treat patient populations including people with hepatitis C virus (HCV) genotype 3, patients with decompensated cirrhosis, and people who were not cured with previous sofosbuvir-containing therapy, according to a series of studies presented at the 49thEASL International Liver Congress (EASL 2014) this week in London.

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EASL 2014: 88% of Previous Relapsers Cured with Simeprevir Triple Therapy

Almost 90% of European patients who had relapsed after previous treatment with pegylated interferon and ribavirin were cured of hepatitis C after 24 weeks of treatment with the protease inhibitor simeprevir (Olysio) combined with pegylated interferon/ribavirin, according to a presentation Thursday at the 49th EASL International Liver Congress (EASL 2014) in London.

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Bristol-Myers Squibb Requests FDA Approval of Daclatasvir and Asunaprevir

Bristol-Myers Squibb has submitted New Drug Applications asking the U.S. Food and Drug Administration (FDA) to approve its experimental hepatitis C virus (HCV) NS5A inhibitor daclatasvir and HCV protease inhibitor asunaprevir, the company announced this week.

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EASL 2014: Sofosbuvir + Ledipasvir Produces Early Cure for 100% of HIV/HCV Coinfected Patients

Treatment for 12 weeks with a coformulation of sofosbuvir plus ledipasvir led to sustained response for all HIV/HCV coinfected individuals with genotype 1 hepatitis C followed for 12 weeks post-treatment, according to interim findings from the ERADICATE study presented at the 49thEASL International Liver Congress (EASL 2014) this week in London.

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FDA Grants Priority Review for Gilead's Sofosbuvir + Ledipasvir Coformulation

The U.S. Food and Drug Administration (FDA) has agreed to expedited review of Gilead Science's sofosbuvir plus ledipasvir coformulation for treatment of chronic hepatitis C, putting the combination pill on track for an approval decision by mid-October, the company recently announced.

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