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AbbVie Submits New Drug Application to U.S. FDA for its Investigational, All-Oral, Interferon-Free Therapy for the Treatment of Hepatitis C

AbbVie (NYSE: ABBV) submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the company's investigational, all-oral, interferon-free regimen for the treatment of adult patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection. AbbVie plans to submit applications for regulatory approval of its regimen in the European Union in early May.

Published
4 hours ago
From
AbbVie press release
Gilead Beats Hepatitis C Sales Estimates by $1 Billion

Gilead Sciences Inc. (GILD) overwhelmed sales estimates for its new blockbuster hepatitis C pill in what analysts called the biggest drug start ever, raising questions about insurers’ ability to slow the use of the costly therapy.

Published
5 hours ago
From
Bloomberg
Sofosbuvir for hepatitis C works well despite multiple negative predictive factors

Hepatitis C treatment using sofosbuvir (Sovaldi) is highly effective even for people with multiple factors traditionally associated with poor response. Having four or more negative predictive factors, however,

Published
6 hours ago
By
Liz Highleyman
Sofosbuvir + new GS-5816 NS5A inhibitor is effective against hepatitis C genotypes 1-6

A new experimental NS5A inhibitor, GS-5816, was shown to be safe and effective when used in an interferon- and ribavirin-free dual regimen with sofosbuvir (Sovaldi) for people

Published
17 April 2014
By
Liz Highleyman
NHS England agrees funding for life-saving hepatitis C drug

NHS England has approved an £18.7 million investment in a new drug for the treatment of hepatitis C. Around 500 patients with acute liver failure, and/or awaiting liver transplantation, are expected to benefit from the decision to fund Sofosbuvir.

Published
17 April 2014
From
NHS England (press release)
England: Patients with end-stage liver disease caused by hepatitis C to get new drug

The NHS is to pay for around 500 people with end-stage liver disease caused by hepatitis C to receive Sofosbuvir, a new drug which could cure them, without waiting for guidance from the advisory body, Nice.

Published
17 April 2014
From
The Guardian
BMS combination cures 90% of genotype 1b hepatitis C in 24 weeks

A combination of two direct-acting antivirals developed by Bristol-Myers Squibb (BMS) cured 90% of previously untreated people with genotype 1b hepatitis C infection in 24 weeks, without

Published
17 April 2014
By
Keith Alcorn
Sofosbuvir + ribavirin is safe and effective for people with hepatitis C who have advanced liver disease

Sofosbuvir plus ribavirin is a safe option that can lead to sustained response in people with advanced liver disease including those with decompensated cirrhosis and portal hypertension, and

Published
16 April 2014
By
Liz Highleyman
Adding interferon to nucleoside antivirals may improve response for people with chronic hepatitis B

Adding pegylated interferon to entecavir (Baraclude) led to greater hepatitis B virus (HBV) viral load decline and higher likelihood of serological response in people with HBeAg-positive chronic hepatitis

Published
16 April 2014
By
Liz Highleyman
AbbVie 3-drug combination cures 92 to 96% of hepatitis C patients with cirrhosis

The largest study of new direct-acting antivirals yet conducted in people with hepatitis C genotype 1 who have compensated cirrhosis has shown that it is possible to

Published
15 April 2014
By
Keith Alcorn
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