Harvoni Tablet: Uses, Dosage, Side Effects, Precautions and Alternates

Quick overview

Harvoni Tablet combines two antiviral medicines, ledipasvir and sofosbuvir, to treat chronic hepatitis C virus infection in adults and children aged 3 years and older. It works by blocking the virus from multiplying, which allows the body to clear the infection and reduces liver damage over time. Harvoni is taken once daily, with or without food, and in some cases is combined with ribavirin depending on the type of hepatitis C and liver condition being treated.

What is Harvoni Tablet

Harvoni is a prescription medicine that combines two antiviral drugs, ledipasvir and sofosbuvir, in one tablet. It is used to treat long-term (chronic) hepatitis C virus infection in adults and children aged 3 years and older.

Harvoni Tablet uses

• Treats hepatitis C genotypes 1, 4, 5, or 6 without cirrhosis or with cirrhosis that hasn't affected liver function
• Treats hepatitis C genotype 1 with cirrhosis that has affected liver function (used together with ribavirin)
• Treats hepatitis C genotype 1 or 4 in people who have had a liver transplant (used together with ribavirin in some cases)

Benefits of Harvoni Tablet

• Helps eliminate hepatitis C virus from the body
• Can cure hepatitis C in many patients
• Helps reduce the risk of liver damage caused by hepatitis C
• May reduce the risk of complications such as cirrhosis when treatment succeeds

How Harvoni Tablet works

Harvoni works by blocking the hepatitis C virus from making copies of itself. One of its two drugs blocks a protein the virus needs to multiply, and the other interferes with the virus's genetic copying process. When the virus can no longer reproduce, it eventually dies and clears from the body, which reduces liver inflammation and prevents further liver scarring.

Harvoni Tablet dosage

Harvoni can be taken with or without food. Try to take it at the same time every day to help you remember and to keep a steady amount of the drug in your body. Tablets should be swallowed whole and should not be crushed or chewed. Oral pellets should be swallowed without chewing, either on their own or mixed gently into a soft, non-acidic food such as pudding, mashed potatoes, or chocolate syrup. If using the pellets with food, take the mixture within 30 minutes of mixing and do not save leftovers for later.

It is important not to miss or skip doses, since missing doses can make the medicine less effective and allow the virus to become resistant. If you miss a dose, take it as soon as you remember, but if it's almost time for your next dose, skip the missed one — never take two doses at once. Ask your doctor before using an antacid or acid-reducing medicine with Harvoni, as timing may need to be separated.

Available forms and strengths

• Tablet (ledipasvir 90 mg / sofosbuvir 400 mg)

Side effects of Harvoni Tablet

Common

• Fatigue
• Headache
• Nausea
• Diarrhea
• Insomnia (trouble sleeping)
• Cough
• Weakness
• Muscle pain
• Shortness of breath
• Irritability
• Dizziness
• Mild allergic reaction with skin rash, itchiness, or flushing

Serious

• Reactivation of hepatitis B virus in people who have both hepatitis C and hepatitis B, which can lead to liver failure or death
• Serious allergic reaction with swelling under the skin (especially eyelids, lips, hands, or feet), or swelling of the throat, mouth, and tongue, and trouble breathing
• Suicidal thoughts or actions, mainly reported when Harvoni is taken together with ribavirin or pegylated interferon/ribavirin
• Dangerously slow heart rate (bradycardia), especially when taken with the heart medicine amiodarone — this has led to the need for a pacemaker or death in some reports

Warnings and precautions

• Harvoni carries the FDA's strongest warning because it can cause the hepatitis B virus to become active again in people who have both hepatitis C and hepatitis B, which can lead to liver failure or death. Your doctor will test you for hepatitis B before starting treatment.
• Taking Harvoni with the heart medicine amiodarone is not recommended because it can cause a dangerously slow heart rate, which in some cases has required a pacemaker or led to a fatal heart attack.
• Missing doses of Harvoni can allow the virus to become resistant to treatment, meaning the drug may no longer work for you, so it's important to take every dose as prescribed.
• Harvoni does not stop you from being able to pass hepatitis C to others, so you should avoid unprotected sex or sharing razors, toothbrushes, or needles.
• It isn't known for certain if Harvoni is safe during pregnancy. Animal studies didn't show harm, but this doesn't guarantee safety in humans. If Harvoni is combined with ribavirin, that combination should not be used during pregnancy because ribavirin can cause serious harm to an unborn baby.
• It isn't known if Harvoni passes into human breast milk. Animal studies showed it passed into milk without harming offspring, but this doesn't guarantee the same result in humans. Talk with your doctor about the risks and benefits before breastfeeding while taking Harvoni.
• It's not known if Harvoni is safe or effective in people with severe kidney disease, including those on dialysis. Harvoni can be used in people with mild or moderate kidney disease.
• People with serious liver damage should be treated by a specialist. Harvoni has been approved for use in both compensated and more advanced (decompensated) cirrhosis, sometimes combined with ribavirin.
• Drinking alcohol while taking Harvoni can increase the risk of side effects like fatigue, headache, nausea, and diarrhea, and can worsen liver scarring. It's best to avoid alcohol while being treated for hepatitis C with Harvoni.

Storage

• Store Harvoni tablets or pellets below 86°F (30°C)
• Keep them in their original container
• Do not use tablets if the seal over the bottle opening is broken or missing
• Do not use pellets if the carton tamper-evident seal or the pellets packet seal is broken or damaged
• Keep out of the reach of children

When to see a doctor

• Get medical help right away if you develop pain on the upper right side of your belly, vomiting, loss of appetite, or yellowing of your skin or eyes — these can be signs of hepatitis B reactivation
• Get medical help right away if you take amiodarone with Harvoni and experience fainting or near-fainting, weakness, chest pain, dizziness, lightheadedness, extreme tiredness, confusion, not feeling well, shortness of breath, or memory problems
• Seek emergency care if you notice signs of a serious allergic reaction, such as swelling of your face, lips, hands, or feet, or swelling of your throat, mouth, or tongue along with trouble breathing
• If you or someone you know has thoughts of suicide or self-harm while taking Harvoni with ribavirin, reach out for support right away by contacting a crisis helpline or emergency services
• If you think you've taken too much Harvoni, contact your doctor or a poison control center right away, or go to the nearest emergency room if symptoms feel severe

Alternatives

• Vosevi
• Mavyret
• Epclusa