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    Drugs in Perspective: Sovaldi (sofosbuvir)

    Hepatitis C is a viral disease that causes the inflammation of the liver which can ultimately lead to a diminished liver function or  liver failure.1 The majority of individuals who are infected with HCV do not present with any symptoms of the disease until the appearance of liver damage. According to the Centers for Disease Control and Prevention it is estimated that approximately 3.2 million Americans are infected with hepatitis C and globally about 150 million people have hepatitis C.1 Up to 85% of those who are initially infected with HCV will not eliminate the virus and become chronically infected.2

    Sovaldi (sofosbuvir), an oral tablet is a direct acting antiviral agent and the first-in-kind nucleotide analog inhibitor that was approved by FDA on December 6, 2013 for the treatment of adults with chronic hepatitis C infection.3 Sovaldi works to inhibit HCV NS5B RNA dependent RNA polymerase which is considered to be an essential component of viral replication. It undergoes a metabolism to form the active uridine analog triphosphate (GS-461203) that is combined into HCV RNA by NS5B polymerase.4

    It is available as a 400-mg once-daily tablet with or without food.4,5  It can be taken in combination with ribavirin or in combination with pegylated interferon and ribavirin for the treatment of chronic hepatitis C.5 The treatment regimen and duration of treatment is generally based on the HCV genotype (genotype 1-4) and or clinical scenarios. There is no dosage adjustment needed for those with a CrCl >30 ml/min, no studies for those with CrCl <30, or those with decompensated cirrhosis. 5,6

    Relevance

    Sovaldi is recognized as a nucleotide analog inhibitor that blocks a particular protein that is needed by hepatitis C for replication.  It is one of two drugs approved by FDA within a 2-week time span to treat chronic HCV infection, with Olysio (simeprevir) being approved on November 22, 2013. 7   Like Sovaldi, Olysio can be used in combination with peginterferon alfa and ribavirin, however Sovaldi  is also the first approved interferon-free treatment regimen for people with HCV genotypes 2 and 3. The approval of Sovaldi offers the opportunity for improved treatment outcomes for individuals diagnosed with hepatitis C who may not have received prior treatment or have been non-responders to other treatments.7  

    HCV Agents Phase 3 and Higher

     

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