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
- Harvoni [package insert]. Foster City, CA: Gilead; 2014.
Product Code : 13249