Harvoni is a prescription-only medication used to treat chronic hepatitis C in adults and children aged 3 and above. Harvoni is an antiviral drug that is taken once a day orally.
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Sofosbuvir and ledipasvir are the two active components. Ledipasvir blocks a protein called HCV NS5A necessary for the multiplication of the hepatitis C virus. Sofosbuvir interferes with the reproduction of the genetic material required for the replication of the virus.
What Is Harvoni?
Harvoni is an FDA-approved direct-acting antiviral medication used to treat various forms of hepatitis C.
Before taking this medication, it is crucial to tell your doctor and pharmacist:
- If you are allergic to any drug, especially sofosbuvir or ledipasvir.
- If you have any disorders such as liver issues, hepatitis B, or diabetes.
- If you take any prescription, over-the-counter, or herbal drugs.
- If you are breastfeeding, pregnant, or planning to become pregnant. Harvoni’s safety during pregnancy and breastfeeding is unknown. Contact your doctor and pharmacist about the risk-benefit ratio of taking Harvoni.
What Is Harvoni Used To Treat?
Harvoni is used to treat hepatitis C, a chronic viral infection that causes inflammation in the liver. It is suggested for adults and children over the age of three who have chronic hepatitis C with or without cirrhosis.
Hepatitis C genotypes are six distinct species or strains of the virus. Harvoni is used to treat a variety of hepatitis C virus genotypes, including genotypes 1, 4, 5, and 6.
How Does Harvoni Work?
Harvoni works by inhibiting the proteins required for hepatitis C virus growth and replication. It also prevents the hepatitis C virus from reproducing its genetic material, stopping the infection from growing.
Both of the active components of Harvoni, sofosbuvir and ledipasvir, have a role in the treatment of hepatitis C.
Ledipasvir works by interfering with a protein called HCV NS5A, which is involved in viral replication. Sofosbuvir prevents the replication of genetic material by inhibiting an RNA-dependent polymerase known as HCV NS5B, which is required for the virus’s proliferation and replication.
How Is Harvoni Administered?
- Harvoni should be taken exactly as prescribed and recommended by your doctor or pharmacist.
- Harvoni can be taken with or without food.
- Harvoni is often taken orally once daily as tablets or pellets for 8 to 12 weeks, depending on your prescription.
- Harvoni should be taken at the same time every day.
- Harvoni tablets should be swallowed as a whole with one glass of water. Do not break, split, crush, or chew the tablets.
- Harvoni oral pellets can be administered by sprinkling and mixing it with non-acidic soft food or swallowing it without food. Examples of non-acidic soft foods include mashed potatoes, ice cream, chocolate syrup, or puddings.
- Any leftover mixtures of Harvoni pellets should be discarded and not stored for later use.
- If you forget to take a dose, take it as soon as you remember. Two dosages should never be taken on the same day.
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Drug Interactions
The following drugs should not be taken with Harvoni because they may interfere with the drug’s reaction or slow its removal from your body.
- Amiodarone
- Flibanserin
- Rosuvastatin
- Rifampin
- Phenytoin
- Phenobarbital
- Carbamazepine
- Primidone
Harvoni Side Effects
Most of Harvoni’s side effects are minor and disappear as your body adjusts to the medication. But if the side effects become severe or persistent, consult your doctor immediately.
Common side effects include:
- Nausea
- Diarrhea
- Headache
- Cough
- Sleep disturbances
- Shortness of breath
- Muscle pain
- Fatigue
Severe side effects include:
- Swelling of the face, throat, or tongue
- Rashes
- Severe dizziness
- Allergic reactions
- Trouble breathing
Alcohol use while taking Harvoni may increase the chance of side effects and exacerbate liver inflammation and scarring.
Strength
Harvoni comes in two oral dosage forms: pellets and tablets.
Tablets come in the following strengths:
- 90 mg/400 mg (This strength contains 90 mg of ledipasvir and 400 mg sofosbuvir.)
- 45 mg/200 mg (This strength contains 45 mg ledipasvir and 200 mg sofosbuvir.)
Pellets come in the following strengths:
- 45 mg/200 mg (This strength contains 45 mg ledipasvir and 200 mg sofosbuvir.)
- 33.75 mg/150 mg (This strength contains 33.75 mg ledipasvir and 150 mg sofosbuvir.)
Dosage Information
The recommended dose for adults is one 90 mg ledipasvir/400 mg sofosbuvir given once daily.
The dose for children is based on body weight:
- Children with a body weight of less than 35 kg with hepatitis C virus are given 45 mg/200 mg once daily.
- Children weighing 35 kg or more are given a 90 mg/400 mg dose of Harvoni once daily.
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How Much Does Harvoni Cost?
The cost of Harvoni depends on several factors, including:
- The type of pharmacy and its location.
- The duration of your treatment.
- The dose and dosage form of Harvoni prescribed by your doctor.
- Whether the price of the Harvoni drug is covered by your health insurance.
On average, the cost of Harvoni is approximately $65,000 for an 8-week treatment, $98,500 for a 12-week treatment, and $197,000 for a 24-week treatment without insurance. Financial assistance is available for those who cannot afford the medication.
FAQs
Does Harvoni completely cure hepatitis C?
Yes. The cure rate of Harvoni drug is around 94% to 99% when you don’t have any other severe disease or complications. After 12 weeks of treatment, in most cases, there is no virus seen in the patient’s bloodstream.
How long is the treatment?
The duration of Harvoni treatment depends on the severity of the patient’s condition, the amount of hepatitis C virus present in the bloodstream of the patient, and whether or not the patient has cirrhosis with hepatitis C. Harvoni medication is prescribed once daily for approximately 8 to 24 weeks of treatment.
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Dr. Martina Mikail, PharmD was born in Egypt and raised in Pennsylvania and California. She graduated from Marshall B. Ketchum University in May 2022. Dr. Mikail is a recipent of the USPS Leadership Award and the CSHP Leadership Award, and is an active member of CSHP, ASHP, and APhA. The most rewarding part of her job is educating patients and counseling them on medications. In her free time, she likes to cook, spend time with family, and read.