ledipasvir / sofosbuvir
Harvoni (ledipasvir / sofosbuvir) is a combination medication containing two antiviral medications, ledipasvir and sofosbuvir (Sovaldi). It is a first-choice treatment option for hepatitis C for certain types of people.
What is Harvoni (ledipasvir / sofosbuvir)?
What is Harvoni (ledipasvir / sofosbuvir) used for?
- Hepatitis C infection genotype 1, 4, 5, and 6
How Harvoni (ledipasvir / sofosbuvir) works
Harvoni (ledipasvir / sofosbuvir) contains 2 antiviral medications that work together to stop the hepatitis C virus from making copies of itself in the body.
Drug facts
Side effects of Harvoni (ledipasvir / sofosbuvir)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Headache (14%)
- Fatigue or tiredness (13%)
- Nausea (7%)
Less Common Side Effects
- Diarrhea
- Difficulty sleeping (insomnia)
The following Harvoni (ledipasvir / sofosbuvir) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
- Slow heartbeat—dizziness, feeling faint or lightheaded, confusion, trouble breathing, unusual weakness or fatigue
Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):
- Diarrhea
- Fatigue
- Headache
- Nausea
- Trouble sleeping
- Worsening mood, feelings of depression
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Pros and cons of Harvoni (ledipasvir / sofosbuvir)
Pros
- Taking the medication for 6 months or less is very effective against hepatitis C
- Few side effects; most common are stomachache, tiredness, and headache
- Can be used in children age 3 years or older
- Available as a generic, which can be more affordable
- Available as an oral pellet for people who can't swallow the tablet or need their dose lowered
Cons
- Heartburn and stomach acid-lowering medications can lower the amount of Harvoni (ledipasvir / sofosbuvir) in your body
- Not a good option for people taking amiodarone, because the combination can cause slow heart rate
- Doesn't treat all the types of hepatitis C like other antiviral combos, such as Epclusa or Mavyret
- Interacts with some HIV antiretroviral medications
- Some people who have hepatitis B and C have had their hepatitis B come back after taking hepatitis C treatment
Pharmacist tips for Harvoni (ledipasvir / sofosbuvir)
- Make sure you take your prescribed dose every day at the same time with or without food. Make sure you continue to take the medication until your provider instructs you to stop.
- If you happen to be hospitalized during your course of heptitis C treatment, make sure you bring your antiviral medications with you to the hospital. Most hospitals do not have hepatitis C medications in stock because they are expensive. They have procedures in place to administer your home medications so that your treatment will not be interupted.
- Tell your hepatitis C provider about all the medications you are taking. Harvoni (ledipasvir / sofosbuvir) interacts with a lot of common medications like famotidine (Pepcid), omeprazole (Prilosec), cholesterol-lowering statins, and HIV antiretrovirals. The interacting medications may need their dose lowered or scheduled around your Harvoni (ledipasvir / sofosbuvir) dose.
- Headaches are a common side effect. You can use over-the-counter acetaminophen (Tylenol) to treat them, but be sure to take less than 2000 mg a day to prevent liver damage. NSAIDs like ibuprofen (Advil) and naproxen (Aleve) are not recommended in people with severe liver problems.
- Do not chew the oral pellets. They can either be taken directly from the packet or sprinkled on non-acidic soft food. Non-acidic soft food include: pudding, chocolate syrup, mashed potatoes, and ice cream.
Common questions about Harvoni (ledipasvir / sofosbuvir)
Yes, a successful treatment with antivirals is considered a cure for heptitis C. In clinical trials, Harvoni (ledipasvir / sofosbuvir) cured 94% to 100% cases of hepatitis C genotype 1.
It's not likely that heptitis C will come back after achieving "SVR," which is considered a cure. However, treatment of hepatitis C doesn't make you immune to the virus, so it's possible to become reinfected. After treatment it's important to continue to protect yourself from hepatitis C and not receive unclean tattoos or share things like razors and needles.
Avoid alcohol while taking Harvoni (ledipasvir / sofosbuvir). It's not known if alcohol interacts with the medication, but alcohol and hepatitis C can both damage the liver.
In the U.S., Gilead makes branded Harvoni (ledipasvir / sofosbuvir). Asegua Therapeutics makes the authorized generic of Harvoni.
Both antiviral medications are very good at curing hepatitis C. Epclusa works for all genotypes of hepatitis C, while Harvoni (ledipasvir / sofosbuvir) works for 4 out of 6 types. Harvoni (ledipasvir / sofosbuvir) can cure hepatitic C in just 8 weeks for certain types of people; the shortest course of Epclusa is 12 weeks.
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Risks and warnings for Harvoni (ledipasvir / sofosbuvir)
Harvoni (ledipasvir / sofosbuvir) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
HEPATITIS B REACTIVATION
- Risk factors: History of hepatitis B infection
Some people who have both hepatitis B and C have had their hepatitis B reactivate or flare up after starting treatment for hepatitic C. This can cause liver problems if not caught and treated. You should be tested for hepatitis B before you start Harvoni (ledipasvir / sofosbuvir). Tell your provider if you've ever had hepatitis B or been treated for it in the past.
SLOW HEART RATE
- Risk factors: Amiodarone | Beta blockers | Heart disease | Liver disease
There have been cases of slow heartbeat and fatal heart problems when people take amiodarone (Pacerone) and Harvoni (ledipasvir / sofosbuvir) together. It usually happens right after Harvoni (ledipasvir / sofosbuvir) is started, but can also happen weeks after the combination is taken. It's more likely to happen in people also taking beta blockers or with severe liver problems. Tell your provider if you are taking or have recently taken amiodarone. They may choose a different hepatitis C medication for you, or closely monitor your heartbeat. Go to the emergency room right away if you take these medications together and feel faint, dizzy, weak, or have trouble breathing.
RIBAVIRIN RISKS
- Risk factors: Taking ribavirin with Harvoni (ledipasvir / sofosbuvir)
People with certain types of liver problems may need to take an antiviral medication called ribavirin in addition to Harvoni (ledipasvir / sofosbuvir). Ribavirin can have a lot of side effects and should not be taken during pregnancy. Make sure to review this medication with your provider and pharmacist before starting your hepatitis C treatment.
Harvoni (ledipasvir / sofosbuvir) dosage
Tablet| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 90mg/400mg | 28 tablets | $11,526.26 | $411.65 |
Typical dosage for Harvoni (ledipasvir / sofosbuvir)
Adults: 1 tablet once a day with or without food. The standard tablet contains 90 mg of ledipasvir and 400 mg of sofosbuvir.
Children: dose is based on the child's weight
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