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Overview: Ledipasvir/sofosbuvir is used to treat chronic hepatitis C virus (HCV) infection. It works by preventing the hepatitis C virus from making copies of itself. Common side effects include headache, tiredness, and weakness. Tell your health care provider about any medical conditions you have or have had in the past, including any other liver problems. Ledipasvir/sofosbuvir comes as either a tablet or pellets that you take by mouth.

Uses

What is ledipasvir/sofosbuvir used for?

Ledipasvir/sofosbuvir is commonly used to treat certain types of chronic hepatitis C virus (HCV) infection.

Ledipasvir/sofosbuvir may also be used for other conditions as determined by your health care provider.

How does ledipasvir/sofosbuvir work (mechanism of action)?

Ledipasvir/sofosbuvir contains two medicines, ledipasvir and sofosbuvir, that work together to prevent the hepatitis C virus from making copies of itself. Ledipasvir/sofosbuvir reduces the amount of virus in your body, which can help your body get rid of the virus.

How is ledipasvir/sofosbuvir supplied (dosage forms)?

Brands and other names

  • Harvoni

Dosage forms and strengths

  • 90 mg/400 mg and 45 mg/200 mg oral tablets
  • 45 mg/200 mg and 33.75 mg/150 mg oral pellets

How should I store ledipasvir/sofosbuvir?

Oral Tablet. Ledipasvir/sofosbuvir oral tablet should be stored in its original container, at a temperature below 86 F (30 C). 

Oral Pellet. Ledipasvir/sofosbuvir oral pellets should be stored at a temperature below 86 F (30 C). Do not open each packet of pellets until you are ready to take it.

Side Effects

What are the most common side effects of ledipasvir/sofosbuvir?

The most common side effects of ledipasvir/sofosbuvir are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Feeling unusually weak or tired
  • Headache

There may be other side effects of ledipasvir/sofosbuvir that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of ledipasvir/sofosbuvir?

While less common, the most serious side effects of ledipasvir/sofosbuvir are described below, along with what to do if they happen.

Hepatitis B Virus Reactivation. If you have the hepatitis B virus in your body or have had hepatitis B in the past, ledipasvir/sofosbuvir could make the virus active again. This could lead to serious liver problems or death. Keep all appointments for blood tests before starting ledipasvir/sofosbuvir and during treatment. Call your health care provider right away if you have any of the following symptoms of hepatitis.

  • Unusual tiredness
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)
  • Nausea, vomiting, or loss of appetite
  • Dark-colored pee
  • Fever or chills
  • Pain in your side
  • Clay-colored stool (poop) 

Severe Allergic Reactions. Ledipasvir/sofosbuvir may cause allergic reactions, which can be serious. Stop taking ledipasvir/sofosbuvir and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Warnings & Precautions

Who should not use ledipasvir/sofosbuvir?

Allergies to Ingredients. People who are allergic to any of the following should not take ledipasvir/sofosbuvir.

  • Harvoni
  • Ledipasvir
  • Sofosbuvir
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in the specific ledipasvir/sofosbuvir products they stock.

What should I know about ledipasvir/sofosbuvir before using it?

Do not take ledipasvir/sofosbuvir unless it has been prescribed to you by a health care provider. Take it as prescribed.

Do not share ledipasvir/sofosbuvir with other people, even if they have the same condition as you. It may harm them.

Ledipasvir/sofosbuvir comes as either tablets or pellets that are swallowed. Read and follow the instructions for the product you have and make sure you understand how to use it properly. If you have any questions, talk to your health care provider.

If you are taking the oral pellets, swallow them whole. Do not chew them. The pellets can either be taken right in the mouth or mixed with food. If you are taking the oral pellets with food, sprinkle them on a spoonful of pudding, mashed potato, chocolate syrup, or other soft nonacidic food at or below room temperature. The oral pellets must be taken within 30 minutes of mixing with food. 

Keep ledipasvir/sofosbuvir out of the reach of children.

Taking certain antacids at the same time as ledipasvir/sofosbuvir can make it not work as well. Talk to your health care provider about the best way to take antacids while taking ledipasvir/sofosbuvir.

Make sure that you get refills before you run out of ledipasvir/sofosbuvir. Do not stop taking it without talking to your health care provider first.

What should I tell my health care provider before using ledipasvir/sofosbuvir?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if ledipasvir/sofosbuvir is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • Past or current hepatitis B infection
  • Liver problems other than hepatitis C infection
  • Liver transplant
  • Kidney problems or are on dialysis
  • HIV

Other Medicines and Supplements. Ledipasvir/sofosbuvir may interact with other medicines and supplements. Before using ledipasvir/sofosbuvir, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. It is not known if or how ledipasvir/sofosbuvir could affect pregnancy or harm a fetus. Tell your health care provider if you are pregnant or plan to become pregnant.

Breastfeeding. It is not known if ledipasvir/sofosbuvir passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should take ledipasvir/sofosbuvir while breastfeeding.

Interactions

Does ledipasvir/sofosbuvir interact with foods or drinks?

There are no known interactions between ledipasvir/sofosbuvir and foods or drinks. 

If you are taking ledipasvir/sofosbuvir oral pellets with food, they should be sprinkled on soft, nonacidic foods. See the Warnings & Precautions section for more information.

It is unknown if drinking alcohol will affect ledipasvir/sofosbuvir.

Does ledipasvir/sofosbuvir interact with other medicines (drug interactions)?

Ledipasvir/sofosbuvir interacts with many other medicines. Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss with your health care provider if you are using any of the following before taking ledipasvir/sofosbuvir.

  • Amiodarone (Pacerone and others), which is a medicine used for an irregular heart rhythm
  • A beta-blocker, such as atenolol (Tenormin), metoprolol (Lopressor, Toprol XL, and others), or propranolol (Inderal LA, Innopran XL), which is a medicine that may be used for certain heart conditions or to lower blood pressure
  • An antacid containing aluminum, calcium, or magnesium
  • An H2 blocker, such as cimetidine (Tagamet), famotidine (Pepcid, Zantac), or nizatidine (Axid)
  • A proton pump inhibitor (PPI), such as esomeprazole (Nexium), lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole (Protonix), or rabeprazole (Aciphex)
  • Rifampin (Rifadin) or rifapentine (Priftin), which are medicines commonly used to treat an infection called tuberculosis
  • Rifabutin (Mycobutin), which is a medicine used to prevent Mycobacterium avium complex infection
  • A medicine for diabetes
  • Digoxin (Lanoxin), which is a medicine used to treat an irregular heartbeat and some types of heart failure
  • Any medicine for seizures, such as carbamazepine, phenobarbital, or phenytoin
  • A medicine for HIV or AIDS, or any other medicine for hepatitis C
  • St. John’s wort, which is a supplement that may be used for depression
  • Atorvastatin (Lipitor and others) or rosuvastatin, which are medicines to lower cholesterol
  • Warfarin, which is a blood thinner 

Many other medicines may alter the blood levels of ledipasvir/sofosbuvir, and vice versa. Tell your health care provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with ledipasvir/sofosbuvir. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much ledipasvir/sofosbuvir?

If you or someone else has used too much ledipasvir/sofosbuvir, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of ledipasvir/sofosbuvir?

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses. 

Missing doses of ledipasvir/sofosbuvir can cause it to not work as well over time. So it is important not to miss or skip doses.

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