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Breaking Hepatitis C News

Breaking News: Gilead submitted an application to the FDA approval of ledipasvir/sofosbuvir, a fixed-dose combination pill to treat genotype 1 hepatitis C. Patients with genotype 1 hepatitis C had a 93-99% chance of a virologic cure with 8 to 12 weeks of ledipasvir/sofosbuvir, depending on prior treatment history and whether they have cirrhosis. This is WITHOUT interferon or ribavirin. Ledipasvir/sofosbuvir is generally well tolerated with mostly mild side effects (fatigue/headache).

AbbVie is just behind Gilead in getting its hepatitis C drug regimen to market. Analysts are guessing that the AbbVie regimen will also be interferon/ribavirin free, and for genotype 1 patients. The response rates and side effects are similar. Perhaps the competition will drive the price down?

My guess is that the Gilead drug will be approved in the last quarter of 2014, and AbbVie will be shortly after.

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