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Hepatitis C

Daclatasvir and Asunaprevir Designated as Hepatitis C "Breakthrough" Therapy

Bristol-Myers Squibb's dual regimen containing the hepatitis C virus NS5A inhibitor daclatasvir plus the HCV protease inhibitor asunaprevir has been granted "breakthrough therapy" status by the U.S. Food and Drug Administration, putting in on track for rapid approval, the company announced this week.

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Deaths Due to Hepatitis C Likely Undercounted

Hepatitis C is "under-documented" on death certificates of people who die with the disease, according to a report in the February 12 advance edition of Clinical Infectious Diseases. Only about 20% of people with HCV-related chronic liver disease had this listed as a cause of death, even though a majority had evidence of moderate or advanced liver fibrosis. A related study in New York City found that people with hepatitis C were at increased risk of dying, and of dying at younger ages.

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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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Daclatasvir + Asunaprevir Works Well for HCV 1b, but 1a Requires Interferon

An all-oral combination of Bristol-Myers Squibb's daclatasvir plus asunaprevir cured nearly 80% of patients with genotype 1b hepatitis C virus (HCV), but people with harder-to-treat HCV subtype 1a needed to add pegylated interferon and ribavirin to achieve high sustained response rates, researchers reported in the March 2014 Journal of Hepatology.

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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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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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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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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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