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Gilead Requests FDA Approval of Sofosbuvir/ Ledipasvir Hep C Combo

Gilead Sciences announced this week that it has filed for U.S. Food and Drug Administration (FDA) approval of a new fixed-dose coformulation containing its recently approved HCV polymerase inhibitor sofosbuvir (Sovaldi, formerly GS-7977) plus its NS5A inhibitor ledipasvir (formerly GS-5885) for interferon-free treatment of genotype 1 chronic hepatitis C.

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AbbVie Oral Regimen Cures Nearly All GT1 Hepatitis C, Phase 3 Trials Now Done

AbbVie announced this week that it has completed Phase 3 clinical trials of its interferon-free regimen containing 3 direct-acting antivirals, with or without ribavirin, for the treatment of chronic hepatitis C. Across all studies, between 90% and 100% of participants achieved sustained virological response, usually with 12 weeks of therapy, including hard-to-treat patient groups such as people with HCV subtype 1a and liver cirrhosis.

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Daclatasvir + Asunaprevir + BMS-791325 Cures Most Genotype 1 Hepatitis C

An interferon-free oral combination of 3 direct-acting antiviral agents developed by Bristol-Myers Squibb led to sustained virological response in more than 90% of treatment-naive chronic hepatitis C patients with HCV genotype 1a or 1b, according to a report in the February 2014 issue of Gastroenterology.

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AASLD, IDSA & IAS-USA Announce New Hepatitis C Treatment Guidelines

The American Association for the Study of Liver Diseases (AASLD), the Infectious Diseases Society of America (IDSA), and the International Antiviral Society-USA (IAS-USA) this week announced the first new hepatitis C treatment guidelines that include next-generation direct-acting antiviral agents recently approved by the FDA. The guidance is available on a new website, HCVguidelines.org, that will enable frequent updates to reflect emerging data.

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Boehringer Ingelheim Halts Testing of Deleobuvir Hepatitis C Regimens

Boehringer Ingelheim will cease development of regimens containing its non-nucleoside hepatitis C virus polymerase inhibitor deleobuvir (formerly BI 207127), the company announced this week.

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