What is a Generic Drug?

A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.

The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.

Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.

Harvoni

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Generic

Generic Equivalent - Harvoni (Ledipasvir/Sofosbuvir)

Prescription Required

Strength
Qty
90mg/400mg

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What is Generic?

  • Product Details

    Description

    HARVONI (ledipasvir/sofosbuvir) is a medication prescribed to treat chronic hepatitis C (HCV) infection. It may be prescribed with or without the antiviral ribavirin. HARVONI generic is not available at this time.

    Directions

    Take 1 tablet (ledipasvir 90 mg/sofosbuvir 400 mg) by mouth once daily with or without food.

    The length of treatment will depend on the genetic makeup of the hepatitis C virus causing the infection. The genetic type will also determine if HARVONI should be used in combination with ribavirin. Do not take HARVONI in a way different than prescribed by your doctor.

    The recommended treatment regimens and durations include:

    • Genotype 1, treatment-naive: HARVONI alone for 12 weeks
    • Genotype 1, treatment-experienced without cirrhosis: HARVONI alone for 12 weeks
    • Genotype 1, treatment-experienced with compensated cirrhosis: HARVONI alone for 24 weeks
    • Genotype 1, treatment-naive or treatment-experienced with decompensated cirrhosis: HARVONI with ribavirin for 12 weeks
    • Genotype 1 or 4: treatment-naive or treatment-experienced liver transplant recipients without cirrhosis or with compensated cirrhosis: HARVONI with ribavirin for 12 weeks
    • Genotype 4, 5, 6: Treatment-naive and treatment-experienced without cirrhosis or with compensated cirrhosis: HARVONI alone for 12 weeks

    Your specific directions may be different than the regimens listed above based on the recommendation from your physician.

    Ingredients

    HARVONI is a combination of two different antiviral medications, ledipasvir, and sofosbuvir. Together, the drugs use two different pathways to stop the hepatitis C virus from copying itself.

    Ledipasvir

    The hepatitis C virus is made up of genetic material and a protective protein coat. The virus uses the protein NS5A to replicate its genetic material and create more virus particles. Ledipasvir inhibits NS5A, preventing viral replication.

    Sofosbuvir

    Hepatitis C viruses also use the protein NS5B RNA-dependent RNA polymerase to replicate its genetic code. Sofosbuvir binds to this protein and stops it from functions.

    Fact Table

    Formula

    C71H83F3N11O15P

    License

    AU, EU EMA, US FDA

    Bioavailability

    76%

    Legal status

    RX Only

    Chemical Name

    Ledipasvir/Sofosbuvir

    Elimination half-life

    47 hours

    Dosage (Strength)

    90mg/400mg (28 tablets)

    Pregnancy

    Consult a doctor

    Brands

    Harvoni, Hepcinat-LP

    Protein binding

    Greater than 99.8%, 61-65%

    PubChem CID

    72734365

    MedlinePlus

    a614051

    ChEBI

    85089, 85083

    ATC code

    J05AP51

    DrugBank

    DB09027, DB08934

    KEGG

    D10578

    Routes of administration

    Oral

    Cautions

    Tell your doctor if you had ever tested positive for the hepatitis B virus. In people with both hepatitis B and hepatitis C infections, hepatitis B virus may reactivate, leading to hepatitis, liver failure, or death.

    Tell your doctor if you are taking the heart rhythm drug amiodarone. People who take both medications may cause the heart to slow (bradycardia). Taking both medications at the same time is not recommended.

    If you have diabetes, the treatment of hepatitis C may improve your blood glucose control. If you are taking medications for diabetes, they may cause hypoglycemia and need to be adjusted.

    Side Effects

    The most common adverse reactions when taking HARVONI include:

    • Asthenia
    • Decreases in hemoglobin
    • Diarrhea
    • Dizziness
    • Fatigue
    • Headache
    • Insomnia
    • Irritability
    • MyalgiaDyspnea
    • Nausea

    The side effects each person experiences will be different based on their disease and other medications they are taking for treatment.

    If you buy HARVONI online from Canada Pharmacy, be sure to tell your plans to your doctor. The HARVONI price may be cheaper when buying online.

    References

    1. Harvoni [package insert]. Foster City, CA: Gilead; 2014.

    Product Code : 13249

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