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AbbVie's 3D Hepatitis C Combo Gets Priority Review in U.S. and Europe

AbbVie's all-oral 3-drug combination regimen for genotype 1 chronic hepatitis C has been granted priority review status by the U.S. Food and Drug Administration (FDA), putting it on track for approval by the end of the year. In related news, the company announced last week that Marketing Authorization Applications for the 3D regimen have been validated and are under accelerated assessment by the European Medicines Agency (EMA), with a decision expected in early 2015.

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Sofosbuvir/Ledipasvir Cures 100% of Genotype 1 Hepatitis C Patients in Japanese Study

All treatment-naive and previously treated participants using a combination pill containing Gilead Science's hepatitis C virus (HCV) polymerase inhibitor sofosbuvir (Sovaldi) and NS5A inhibitor ledipasvir, without ribavirin, for 12 weeks achieved sustained virological response in a Phase 3 study in Japan, where most hepatitis C patients have HCV genotype 1b.

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HCV Drug Development: Merck Acquires Idenix, FDA Lifts Sovaprevir Hold

Merck this week announced that it will purchase Idenix, a specialty biopharmaceutical company developing several hepatitis C virus (HCV) drug candidates. In related news, Achillion announced that the U.S. Food and Drug Administration (FDA) has lifted a clinical hold on one of its drugs and a clinical trial of another is now underway.

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Daclatasvir + Asunaprevir Is Highly Effective Against Hepatitis C Genotype 1b

An all-oral combination of daclatasvir plus asunaprevir, without pegylated interferon or ribavirin, cured 87% of genotype 1b patients who were ineligible for or could not tolerate interferon and 81% of prior non-responders in a Japanese study published in the June 2014 edition of Hepatology.

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Hepatitis C Cascade Studies Show Gaps in Testing and Treatment

About half of people with hepatitis C are aware of their infection but less than 10% have been successfully treated and achieved sustained virological response, according to a meta-analysis presented at the recent Conference on Retroviruses and Opportunistic Infections (CROI 2014). A related study found that among HIV/HCV coinfected people, 40% had been referred to hepatitis C care but only 4% were cured.

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