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 (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
US: FDA
Routes of administration
By mouth
Legal status
Rx Only
Chemical Name
Ledipasvir/Sofosbuvir
Elimination half-life
47 hours, 0.4 hours
Dosage (Strength)
90mg/400mg, 45mg/200mg
Pregnancy
Not classified yet
Brands
Harvoni
Protein binding
>99.8%, 61-65%
PubChem CID
72734365
MedlinePlus
a614051
ChEBI
85089, 85083
ATC code
J05AP51
DrugBank
DB09027, DB08934
KEGG
D10578
Bioavailability
-
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.
IMPORTANT NOTE:
The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.
Prescription Required
