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FDA Approves Gilead's Epclusa Combo Pill for All Hepatitis C Genotypes

On June 28 the U.S. Food and Drug Administration (FDA) approved Gilead Sciences Epclusa, a new once-daily combination pill containing sofosbuvir and velpatasvir, for the treatment of adults with hepatitis C virus (HCV) genotypes 1 through 6 -- the first approved oral pangenotypic regimen. While it is more effective against more types of HCV, Epclusa will cost less than most earlier interferon-free direct-acting antiviral regimens.

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EASL 2016: DAAs for Hepatitis C Achieve Excellent Outcomes in Real-World Settings

Hepatitis C therapy with direct acting antivirals (DAAs) is as effective in real-world settings as it was in clinical trials, according to U.S. research presented at the International Liver Congress in Barcelona last week. Investigators from the Department of Veteran Affairs (VA) analyzed outcomes in over 9000 patients treated with DAA combinations. Outcomes were excellent, with 2 combinations achieving cure rates of 93%, similar to those seen in randomized studies with strict eligibility criteria and close follow-up.

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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 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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AASLD 2015: High Cure Rate for People Retreated After Failure of Short Course DAA Therapy

Hepatitis C patients who did not achieve sustained virological response with a prior short course of direct-acting antiviral (DAA) therapy had a high likelihood of being cured if treated again with sofosbuvir/ledipasvir standard therapy, according to results from the SYNERGY study presented at the 2015 AASLD Liver Meeting last week in San Francisco. A related analysis showed that emergence of certain drug-resistance mutations was common during very short therapy, but this did not appear to compromise response to retreatment.

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