28-Oct-14 10:15 AM  CST

FDA Approves Harvoni: The First Combination Drug used to Treat Hepatitis C

Hepatitis C is a contagious viral disease state of the liver. Hepatitis C can be either acute, short term or chronic, long-term. Hepatitis C Virus (HCV) is spread mostly commonly through blood contact with another person infected with HCV. The Centers for Disease Control and Prevention (CDC) estimates that 3.2 million people are infected with HCV, and a large number of that those infection are unaware of the infection.

            Recently, the Food and Drug Administration (FDA) approved the first once daily, combination treatment for HCV. Harvoni, produced by Gileand Science, is approved to treat genotype 1 Hepatitis C. Approximately 70% of all HCV infections are genotype 1. Harvoni (ledpasir 90mg /sofosbuvir 400mg) allows the patient to have a once a day dosing therapy, which allows for greater chance of patient compliance. In addition, a typical treatment therapy of Harvoni will last approximately 12 weeks, where other HCV treatment therapies can last as long as 24 weeks.

            According to the FDA’s website, Harvoni is the 3rd new drug approved for the treatment of HCV, Olysio (simeprevir) in November 2013 and Sovaldi (sofosbuvir) in December 2013, over the last year. While most of the advantages of Harvoni seem to outweight the disadvantages, headaches and fatigue were common complains among test subject, the cost of treatment is equivalent to a 911 Porsche Carrera. The cost of and average 12 -week therapy is $94,500. Many insurers are already bulking at paying for Harvoni. While the advantages of Harvoni remain positive, its cost may be the one barrier that keeps patients from being able to take advantage of its benefits.

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Source: Sandy Andrews  

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