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    The year's Top Drugs


    Drugs that are driving growth

    Ledipasvir/Sofosbuvir (Harvoni®), a direct acting antiviral therapy that is specifically targeted as a NS5A inhibitor /NS5B polymerase inhibitor, was FDA approved in 2014 as the first once-daily tablet for hepatitis C virus (HCV) genotype 1 infection. In 2015, the FDA approved it for expanded indications for HCV genotypes 4, 5, and 6, in addition to recommending dosing in those who are co-infected with HIV and HCV. Moreover, those with genotype 1 who are treatment-experienced with cirrhosis may be eligible to receive Harvoni® with ribavirin for 12 weeks.1

    Sofosbuvir/velpatasvir (Epclusa®) is another combination NS5B polymerase inhibitor/ NS5A inhibitor  and is the latest drug approved, earlier this year, for HCV. It is the first regimen that can be used in genotypes 1, 2, 3, 4, 5, and 6  alone in those without cirrhosis or in those with Child-Pugh A. In those with decompensated cirrhosis (Child-Pugh B or C), it would be combined with ribavirin. It was approved on the basis of four randomized trials, ASTRAL-1, 3, and 4 with high sustained virilogical response and tolerable adverse effects.2

    Glatiramer acetate (Copaxone®) is a disease –modifying injectable drug approved in 1996 for relapsing forms of multiple sclerosis (MS).3 In 2015, a generic form of the drug, GlatopaTM , was approved in an effort to reduce prices and increase access to patients who cannot afford the drug. The main difference in dosing is that Copaxone comes in 20mg/mL to be given subcutaneously daily or the 40mg/mL to be given three times a week . GlatopaTM was approved in the 20mg/mL dosing only. The dosing is not interchangeable for the 40mg/mL strength.4

    Dimethyl Fumarate (Tecfidera®) is a twice daily oral disease-modifying drug approved in 2013 for relapsing forms of MS. Although its mechanism is not fully known in MS, it is thought to be involved in enabling cellular response to oxidative stress caused in MS. Dimethyl fumarate’s product information was updated recently to highlight progressive multifocal leukoencephalopathy (PML) as an adverse effect.5


    1. Harvoni [product information]. Foster City, CA: Gilead Sciences, Inc.; Updated 2016

    2. Epclusa [product information]. Foster City, CA: Gilead Sciences, Inc.; 2016

    3. Copoxone [product information]. North Wales, PA: Teva Pharmaceuticals, Inc.: Revised 2016

    4. Glatopa [product information]. Princeton, NJ: Sandoz Inc. (a Novartis company): 2015


    Monica Shah, PharmD
    Monica Shah, PharmD is a Clinical Pharmacist at RWJ Barnabas Health in New Jersey and adjunct faculty member at Ernest Mario School of ...


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