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Hepatitis C

Gilead 4-Drug Hepatitis C Combo Shows Modest Efficacy in Phase 2 Trial

An interferon-free regimen containing 3 direct-acting antiviral drugs plus ribavirin cured about 60% of genotype 1 hepatitis C patients treated with the highest dose for 24 weeks, according to study findings reported in the February 5 advance edition of Hepatology -- only a modest cure rate compared with some other new regimens with cure rates approaching 100%.

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Study Sheds Light on How Hepatitis C Virus Evades Immune System

Hepatitis C virus (HCV) appears to disable a specific variant of the IFNL3 gene, which plays a role in the immune system's response against viral infection, explaining how people with a favorable gene pattern are more likely to clear the virus naturally or with interferon-based treatment, researchers reported in the January 2014 issue of Nature Immunology.

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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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Sofosbuvir/Ledipasvir Coformulation Cures 95% of Genotype 1 Hepatitis C

Between 95% and 100% of treatment-naive patients and prior non-responders with genotype 1 chronic hepatitis C achieved sustained virological response using a fixed-dose combination of sofosbuvir plus ledipasvir, with or without ribavirin, according to findings from the Phase 2 LONESTAR study published in the February 8, 2014, edition of The Lancet.

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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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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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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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Hepatitis C May Increase Risk of Strokes

Hepatitis C virus (HCV) infection significantly increases the likelihood of having a stroke, but further information is needed to understand underlying mechanisms and identify related risk factors such as HCV genotype, according to a meta-analysis described in the November 12, 2013, edition of PLoS ONE.

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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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