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Harvoni Coformulation Approved in Europe for Hepatitis C Genotypes 1 & 4

Gilead Sciences' Harvoni, a once-daily fixed-dose coformulation containing the nucleotide HCV polymerase inhibitor sofosbuvir and the NS5A replication complex inhibitor ledipasvir, has been approved by the European Commission for the treatment of people with hepatitis C genotypes 1 and 4, the company announced this week.

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AASLD 2014: Daclatasvir + Sofosbuvir Demonstrates Good Cure Rate for HCV Genotype 3 Patients

An all-oral combination of daclatasvir (Daklinza) plus sofosbuvir (Sovaldi) taken for 12 weeks produced sustained virological response rates of 90% for previously untreated patients and 86% for prior non-responders with hepatitis C virus genotype 3 in the Phase 3 ALLY-3 trial, researchers reported last week at the American Association for the Study of Liver Diseases (AASLD) Liver Meeting in Boston. This regimen did not work as well, however, for people with liver cirrhosis.

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AASLD 2014: Daclatasvir TRIO Regimen Has Good Cure Rates With or Without Cirrhosis

A 12-week oral regimen of daclatasvir, asunaprevir, and beclabuvir, with or without ribavirin, cured 86% to 90% of genotype 1 hepatitis C patients with cirrhosis in the Phase 3 UNITY-2 trial, while the TRIO regimen without ribavirin demonstrated similar sustained response rates for non-cirrhotics in UNITY-1, according to 2 late-breaking reports presented at the American Association for the Study of Liver Diseases (AASLD) Liver Meeting this week in Boston. Findings suggest that ribavirin is still useful for some harder-to-treat patients.

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AASLD 2014: Sofosbuvir + GS-5816 for 12 Weeks Shows High Cure Rates, 8 Weeks Less Effective

A 12-week oral combination of sofosbuvir plus the experimental NS5A inhibitor GS-5816 demonstrated high sustained virological response rates for people with difficult-to-treat HCV genotype 3 and other genotypes, according to Phase 2 study findings presented at the American Association for the Study of Liver Diseases (AASLD) Liver Meeting last week in Boston. Reducing treatment duration to 8 weeks resulted in lower efficacy for people with HCV genotypes 1 and 2, though genotype 3 patients still showed high response rates.

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FDA Approves Simeprevir + Sofosbuvir Combination for Hepatitis C

The U.S. Food and Drug Administration (FDA) this week announced additional approval of interferon-free oral therapy for chronic hepatitis C combining Janssen's HCV protease inhibitor simeprevir (Olysio) plus Gilead Sciences' HCV polymerase inhibitor sofosbuvir (Sovaldi), both of which were approved separately in late 2013.

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