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FDA Approves Harvoni for Hepatitis C Patients with Advanced Liver Disease

The U.S. Food and Drug Administration (FDA) has approved an expanded indication for Gilead Sciences sofosbuvir/ledipasvir coformulation (Harvoni) plus ribavirin for genotype 1 chronic hepatitis patients with decompenated liver cirrhosis and for genotype 1 or 4 liver transplant recipients without cirrhosis or with compensated cirrhosis, the company announced this week.

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FDA Approves Daclatasvir + Sofosbuvir for Hard-to-Treat Hepatitis C Patients

The U.S. Food and Drug Administration (FDA) this month approved an expanded indication for Bristol-Myers Squibb's daclatasvir (Daklinza) and Gilead Sciences sofosbuvir (Sovaldi) for additional patient groups including people with HIV/HCV coinfection, patients with advanced liver cirrhosis, and liver transplant recipients.

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FDA Approves Zepatier (Grazoprevir/Elbasvir) for Hepatitis C Genotypes 1 and 4

The U.S. Food and Drug Administration (FDA) this week announced its approval of Merck's Zepatier -- a once-daily coformulation containing the hepatitis C virus (HCV) protease inhibitor grazoprevir and NS5A inhibitor elbasvir -- for the treatment of HCV genotypes 1 and 4. In several Phase 3 studies grazoprevir/elbasvir taken for 12 weeks demonstrated cure rates exceeding 90% for various groups including people with liver cirrhosis, HIV/HCV coinfected patients, and people who inject drugs.

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AASLD 2015: MiR-122 Inhibitor RG-101 Suppresses Hepatitis C Virus with Single Dose

A single injection of RG-101, an experimental drug that targets the micro RNA miR-122 in liver cells, reduced hepatitis C virus (HCV) levels by more than 4 log in people with HCV genotypes 1, 3, and 4, and 21% of treated patients still had undetectable virus levels 28 weeks after dosing, according to research presented at the AASLD Liver Meeting in November.

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AbbVie Opens Global Phase 3 Studies of ABT-493/ABT-530 Hepatitis C Regimen

AbbVie has started enrollment of a projected 1600 participants in 6 new international Phase 3 clinical trials evaluating a once-daily regimen of its investigational NS3/4A protease inhibitor ABT-493 and NS5A inhibitor ABT-530 for people with hepatitis C virus (HCV) genotypes 1 through 6, the company recently announced.

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