FDA warning: Reactivation of hepatitis B virus
This drug has a boxed warning. This is the most serious warning from the Food and Drug Administration (FDA). A boxed warning alerts doctors and patients about drug effects that may be dangerous.
When people who are coinfected with both hepatitis C and hepatitis B start taking Harvoni, there is a risk of reactivation of the hepatitis B virus (HBV). Reactivation means the virus becomes active again. Reactivation of HBV can lead to liver failure or death. Your doctor will test you for HBV before you start Harvoni treatment. If you’re found to have HBV, you may need to take medication to treat it.
What is Harvoni?
Harvoni is a brand-name prescription medication that’s used to treat hepatitis C. Harvoni contains two drugs: ledipasvir and sofosbuvir. It comes as a tablet that’s typically taken once daily for 12 weeks.
Harvoni is a type of drug called a direct-acting antiviral (DAA). It was approved by the FDA in 2014 to treat several different genotypes, or forms, of hepatitis C.
Harvoni is approved to treat hepatitis C:
- in people with hepatitis C genotypes 1, 4, 5, and 6
- in people with or without cirrhosis
- in people who have had a liver transplant
- in adults or children who are 12 years or older or who weigh at least 77 pounds
In most clinical studies for Harvoni, the success rate for curing hepatitis C was greater than 90 percent. This means that nearly all people who took Harvoni achieved a sustained virologic response (SVR). SVR means that they had no virus detected in their body 12 weeks or longer after treatment ended.
Harvoni generic
Harvoni contains two drugs in one tablet: ledipasvir and sofosbuvir. There are currently no generic forms of either the combination drug or the individual drugs. Harvoni is only available as a brand-name prescription medication.
However, a generic version of Harvoni is expected to be released in early 2019.
Harvoni side effects
Harvoni can cause mild or serious side effects. The following list contains some of the key side effects that may occur while taking Harvoni. This list doesn’t include all possible side effects.
For more information on the possible side effects of Harvoni or tips on how to deal with a troubling side effect, talk with your doctor or pharmacist.
If your doctor also prescribes ribavirin for you to take with Harvoni, you may have additional side effects. (See “Harvoni and ribavirin” below.)
More common side effects
The more common side effects of Harvoni can include:
In some cases, Harvoni can cause a mild allergic reaction. Symptoms can include skin rash, itchiness, and flushing (skin warmth and redness, typically in your face and neck).
Most of these side effects may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.
Serious side effects
Serious side effects from Harvoni aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.
Serious side effects and their symptoms can include the following:
- Hepatitis B reactivation in people coinfected with hepatitis C and hepatitis B. Some people who have both hepatitis C and hepatitis B have experienced a reactivation of the hepatitis B virus when they began treatment with Harvoni. Reactivation means the virus becomes active again. Reactivation of the hepatitis B virus can lead to liver damage, liver failure, or death. Before you start treatment with Harvoni, your doctor will test you for hepatitis B. You may need to take medication to treat hepatitis B.
- Serious allergic reaction. In rare cases, Harvoni can cause a serious allergic reaction. Symptoms can include:
- angioedema (swelling under your skin, typically in your eyelids, lips, hands, or feet)
- swelling of your throat, mouth, and tongue
- trouble breathing
- Suicidal thoughts. In rare cases, Harvoni can cause suicidal thoughts or actions when it’s taken in combination with ribavirin or pegylated interferon/ribavirin.
Suicide prevention
- If you know someone at immediate risk of self-harm, suicide, or hurting another person:
- Call 911 or the local emergency number.
- Stay with the person until professional help arrives.
- Remove any weapons, medications, or other potentially harmful objects.
- Listen to the person without judgment.
- If you or someone you know is having thoughts of suicide, a prevention hotline can help. The National Suicide Prevention Lifeline is available 24 hours a day at 1-800-273-8255.
Long-term side effects
Long-term side effects haven’t not been reported with use of Harvoni.
However, people with cirrhosis (liver scarring) may continue to have symptoms of liver damage after their hepatitis C is cured. If you have cirrhosis, your doctor will want to check your liver function regularly during and after treatment with Harvoni.
Side effects after treatment
Side effects after Harvoni treatment haven’t been reported in clinical studies.
However, after finishing treatment with Harvoni, some people may experience flu-like symptoms, such as muscle aches, chills, fatigue, and trouble sleeping. These side effects are likely caused by your body recovering after the hepatitis C virus is cleared.
If you have flu-like symptoms after you finish treatment with Harvoni, talk to your doctor.
Weight loss or weight gain
Changes in weight during Harvoni treatment weren’t reported in clinical studies. However, some people have lost weight as a symptom of hepatitis C. If you have severe changes in weight, talk with your doctor.
Withdrawal symptoms
Stopping treatment with Harvoni hasn’t caused withdrawal symptoms in clinical studies.
Some people may experience symptoms that resemble withdrawal, such as flu-like fever, headache, and muscle pains. However, it’s unclear if these symptoms are related to stopping Harvoni treatment.
Joint pain
Joint pain wasn’t a side effect of Harvoni in clinical studies.
Many people with hepatitis C experience joint pain as a symptom of the virus, though. This can be the result of chronic inflammation or an autoimmune process attacking your joints.
If you’re having pain in your joints, talk to your doctor about ways to manage it.
Eye effects
In clinical studies of Harvoni, people taking the drug did not experience eye problems. But there is one report of temporary vision loss after using Harvoni with the drug ribavirin. And another person reported eye inflammation and blurred vision after using sofosbuvir (one of the medications in Harvoni) and ribavirin.
However, it’s not clear if Harvoni or its ingredients caused the eye problems in these cases. Also, a 2019 study found that these same medications didn’t cause eye problems in people with hepatitis C.
In any case, if you experience any eye effects while taking Harvoni, talk to your doctor right away.
Hair loss
Hair loss wasn’t reported as a side effect in clinical studies of Harvoni. Some people have reported losing hair while taking the drug, but it’s not clear if Harvoni was the cause of their hair loss.
It’s important to note that hair loss can be a symptom of hepatitis C. The hepatitis C virus (HCV) prevents your liver from working properly. You need a healthy liver to get nutrients from the food you eat. So if you can’t obtain the nutrients your body needs, you may experience hair loss.
If you’re concerned about hair loss, talk with your doctor.
Rash/itching
Skin rashes were reported in some people who took Harvoni in clinical studies, but it’s unclear how common they were. In some cases, people had blisters and swelling of the skin, too. These could be caused by allergic reactions to Harvoni.
Itchy skin and rashes are also symptoms of the hepatitis C virus. In addition, they can be signs of serious liver damage. Talk to your doctor if you are experiencing rashes or bothersome itchy skin.
Diarrhea
In clinical studies of Harvoni, between 3 percent and 7 percent of people experienced diarrhea during treatment. Diarrhea may go away with continued use of the drug.
If you have severe diarrhea, or diarrhea that lasts more than a couple days, talk to your doctor right away.
Depression
Depression is an uncommon side effect of Harvoni. In clinical studies, less than 5 percent of people who took Harvoni experienced depression. In addition, suicidal thoughts occurred in less than 1 percent of people who took Harvoni with ribavirin or pegylated interferon/ribavirin.
Many people with hepatitis C can feel depressed because of their diagnosis. If you feel depressed, talk with your doctor about ways to improve your mood. And if you have thoughts of harming yourself, call your doctor right away.
Fatigue
Fatigue, or lack of energy, is a common side effect of Harvoni. In clinical studies, up to 18 percent of people who took Harvoni experienced fatigue.
Fatigue may go away with continued use of Harvoni. However, if your fatigue is severe and affecting your life, talk to your doctor.
Insomnia (trouble sleeping)
In clinical studies, insomnia occurred in up to 6 percent of people who took Harvoni. This side effect may go away with continued use of the drug.
Ways to improve your sleep include following a regular sleep schedule and keeping electronics, such as smartphones, out of your bedroom. If your insomnia is bothersome and doesn’t go away, talk with your doctor about other ways to help you sleep.
Headache
Headache is a common side effect of Harvoni. In clinical studies, up to 29 percent of people who took Harvoni experienced headaches. If you’re having headaches while taking Harvoni, talk to your doctor about ways to help you manage them.
Liver cancer/cancer
Harvoni is a drug called a direct-acting antiviral (DAA). Treating hepatitis C with DAAs helps to prevent long-term effects, such as liver cancer. However, there have been reports of liver cancer in people who had been cured of hepatitis C with Harvoni treatment.
One clinical study found that people with cirrhosis who were treated with a DAA had a greater risk of developing liver cancer as compared to those without cirrhosis. However, people without cirrhosis can still get liver cancer.
If you’re concerned about your risk of developing liver cancer, talk to your doctor.
Harvoni cost
As with all medications, the cost of Harvoni can vary. To find current prices for Harvoni in your area, check out GoodRx.com.
The cost you find on GoodRx.com is what you would pay without insurance. Your actual cost will depend on your insurance coverage.
Financial and insurance assistance
If you need financial support to pay for Harvoni, or if you need assistance understanding your insurance coverage, help is available.
Gilead Sciences, Inc., the manufacturer of Harvoni, offers a program called Harvoni Support Path. For more information and to find out if you’re eligible for support, call 855-769-7284 or visit the program website.
Harvoni uses
The Food and Drug Administration (FDA) approves prescription drugs such as Harvoni to treat certain conditions.
Harvoni is FDA-approved for treating hepatitis C virus (HCV). Harvoni can be prescribed for:
- Adults and children (aged 12 and older or who weigh at least 77 pounds) who:
- have HCV genotype 1, 4, 5, or 6. Genotypes are different strains, or types, of the virus.
- have or don’t have compensated cirrhosis. Cirrhosis is serious scarring in the liver that prevents it from working properly. Compensated cirrhosis is cirrhosis that generally doesn’t cause symptoms.
- Adults who:
- have genotype 1 and decompensated cirrhosis. Decompensated cirrhosis is when the liver is failing and causing serious health issues. People with decompensated cirrhosis will need to take Harvoni with a second drug, ribavirin (Rebetol).
- have genotype 1 or 4 and have had a liver transplant.
This table illustrates who is eligible for Harvoni treatment:
| Genotype 1 | Genotype 2 | Genotype 3 | Genotype 4 | Genotype 5 | Genotype 6 | |
| Without cirrhosis | Y | Y | Y | Y | ||
| Compensated cirrhosis | Y | Y | Y | Y | ||
| Decompensated cirrhosis | Y (adults only) | |||||
| Liver transplant recipient | Y (adults only) | Y (adults only) |
Harvoni dosage
Harvoni is prescribed as a single dosage: A tablet that contains 90 mg of ledipasvir and 400 mg of sofosbuvir, taken once per day.
In certain situations, your doctor may prescribe a second drug to take with Harvoni. For example, you may be prescribed ribavirin (Rebetol) in combination with Harvoni.
This may happen if you have decompensated cirrhosis (severe symptoms from advanced liver disease) or if you have taken certain medications to treat hepatitis C in the past. Your ribavirin dosage would depend on your weight, kidney function, and other health conditions.
The following information describes the recommended dosage of Harvoni.
Drug forms and strengths
Harvoni is available in one strength. It comes in a combination tablet that contains 90 mg of ledipasvir and 400 mg of sofosbuvir.
Dosage for hepatitis C
The dosage to treat hepatitis C is one tablet (90 mg ledipasvir/400 mg sofosbuvir), taken once per day.
Duration of treatment
How long you take Harvoni will depend on your hepatitis C genotype (strain of the virus). It will also depend on your liver function, and any hepatitis C treatments you’ve tried in the past.
Most people take Harvoni for 12 weeks, but treatment can also last 8 or 24 weeks. Your doctor will determine the right duration of treatment for you.
What if I miss a dose?
It’s important to take Harvoni every day for the full period of time your doctor prescribes. Missing or skipping doses can cause the virus to become resistant to Harvoni. Resistant means that the drug no longer works for you.
Using a reminder tool can help you remember to take Harvoni every day.
If you do miss a dose, take it as soon as you remember. If you don’t remember until the next day, don’t take two doses of Harvoni at once. This can increase the risk of side effects. Just take your regular dose of Harvoni.
Sticking to your Harvoni treatment plan
It’s extremely important that you take your Harvoni tablets exactly as your doctor prescribes. This is because following your treatment plan increases your chances of curing your hepatitis C (HCV). It also helps reduce your risk of the long-term effects of HCV, which include cirrhosis and liver cancer.
Missing doses can make Harvoni less effective in treating your HCV. In some cases, if you miss doses, your HCV may not be cured.
Be sure to follow your doctor’s instructions and take one Harvoni tablet every day for the full length of your treatment. Using a reminder tool can help you make sure you take Harvoni each day.
If you have any questions or concerns about your treatment, talk with your doctor. They can help resolve any issues for you and help you get the most effective treatment for your hepatitis C.
Harvoni and alcohol
Drinking alcohol while taking Harvoni can increase the risk of certain side effects from Harvoni. These side effects include:
- fatigue
- headache
- nausea
- diarrhea
In addition, both hepatitis C and excessive alcohol use cause scarring and inflammation in your liver. Combining the two increases your risk of cirrhosis and liver failure.
Alcohol may also make you less able to take your medication as directed by your doctor. For instance, it may cause you to forget to take your medication at the right time. Missing doses of Harvoni could make it less effective in treating your HCV.
For all of these reasons, you should avoid drinking alcohol when you have hepatitis C. This is especially true when you’re being treated with Harvoni. If you have trouble avoiding alcohol, talk with your doctor.
Harvoni with ribavirin
Harvoni is usually taken on its own to treat hepatitis C. However, in some cases, it’s taken with another drug called ribavirin (Rebetol).
Your doctor may prescribe ribavirin with Harvoni if you:
- have decompensated cirrhosis
- have had a liver transplant
- have had unsuccessful treatment with certain other hepatitis C medications in the past
Harvoni and ribavirin are used together in people in these situations because clinical studies showed a higher cure rate with the combination treatment than with Harvoni alone.
Treatment with ribavirin typically lasts 12 weeks. Ribavirin comes as a pill that you take twice a day. The dose you take will be based on your weight. It may also be based on your kidney function and hemoglobin levels.
Ribavirin side effects
Ribavirin can cause several common and serious side effects. It also comes with important warnings.
Boxed warning
Ribavirin has a boxed warning from the FDA. A boxed warning is the strongest kind of warning that the FDA requires. Ribavirin’s boxed warning advises that:
- Ribavirin shouldn’t be used alone to treat hepatitis C because it’s not effective by itself.
- Ribavirin can cause a type of blood disorder called hemolytic anemia. This condition can lead to heart attack or death. Because of this risk, people who have serious or unstable heart disease shouldn’t take ribavirin.
- When ribavirin is used in pregnant women, it can cause serious harm or death to the fetus. Ribavirin shouldn’t be taken by pregnant women or their male sexual partners during pregnancy. Pregnancy should also be avoided for at least six months after ribavirin treatment ends. During this time, consider using a backup form of contraception (birth control).
Other side effects
Ribavirin can also cause some common side effects, such as:
- fatigue
- feeling anxious
- fever
- headache
- feeling irritable
- loss of appetite
- muscle pain or weakness
- nausea
- vomiting
Rare but serious side effects seen in clinical studies included anemia, lung disease, and pancreatitis. They also included eye problems, such as infections and blurry vision.
Ribavirin and pregnancy
See “Boxed warning” above.
Ribavirin and breastfeeding
It’s not known if ribavirin passes into human breast milk. Studies in animals show that ribavirin taken by the mother could be harmful to nursing young. However, animal studies don’t always predict what will occur in humans.
If you’re considering ribavirin treatment while you’re breastfeeding, talk to your doctor. They may recommend that you either stop breastfeeding or avoid ribavirin treatment.
Harvoni interactions
Harvoni can interact with several other medications. It can also interact with certain supplements and foods.
Different interactions can cause different effects. For instance, some can interfere with how well a drug works, while others can cause increased side effects.
Harvoni and other medications
Below is a list of medications that can interact with Harvoni. This list doesn’t contain all drugs that may interact with Harvoni.
Before taking Harvoni, be sure to tell your doctor and pharmacist about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.
If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.
Antacids
Taking Harvoni with antacids, such as Mylanta or Tums, can reduce the amount of Harvoni your body absorbs. This can make Harvoni less effective. To prevent this interaction, separate the dose of Harvoni and antacids by at least four hours.
H2 blockers
Taking Harvoni with drugs called H2 blockers can decrease the amount of Harvoni that’s absorbed into your body. This can cause Harvoni to be less effective at fighting the hepatitis C virus.
If you need to take an H2 blocker with Harvoni, you should either take them at the same time or take them 12 hours apart. Taking them at the same time allows the drugs to dissolve and be absorbed by your body before the effects of the H2 blocker kicks in. Taking them 12 hours apart also allows each drug to be absorbed by your body without interacting with the other drug.
Examples of H2 blockers include ranitidine (Zantac), famotidine (Pepcid), and cimetidine (Tagamet HB).
Amiodarone
Taking Harvoni with amiodarone (Pacerone, Nexterone) can cause a dangerously slow heart rate, which is called bradycardia. Some reports have stated that people who took amiodarone and Harvoni together needed a pacemaker to maintain a regular heart rate. They also reported that other people had a fatal heart attack.
Taking amiodarone and Harvoni together isn’t recommended. If you have to take Harvoni and amiodarone together, your doctor will closely monitor your heart function.
Digoxin
Taking Harvoni with digoxin (Lanoxin) can increase the amount of digoxin in your body. Digoxin levels that are too high can lead to dangerous side effects.
If you need to take Harvoni and digoxin together, your doctor will closely monitor your digoxin levels. They may change your digoxin dose to lower the risk of side effects.
Seizure medications
Taking Harvoni with certain seizure medications can decrease the amount of Harvoni your body absorbs. This can reduce the effectiveness of Harvoni. For this reason, you shouldn’t take Harvoni with these seizure medications.
Examples of seizure medications to avoid while taking Harvoni include:
- carbamazepine (Carbatrol, Equetro, Tegretol)
- phenytoin (Dilantin, Phenytek)
- phenobarbital
- oxcarbazepine (Trileptal)
Antibiotics
Certain antibiotic medications can decrease Harvoni levels in your body. This can make Harvoni less effective. To prevent this interaction, avoid taking Harvoni with the following antibiotics:
- rifabutin (Mycobutin)
- rifampin (Rifadin, Rimactane)
- rifapentine (Priftin)
HIV medications
Taking Harvoni with certain HIV medications can change your body’s levels of either Harvoni or the HIV medications. These interactions can make the drugs less effective or increase your risk of side effects.
Tenofovir disoproxil fumarate
Taking Harvoni with medications that contain tenofovir disoproxil fumarate can increase levels of tenofovir in your body. This will increase the risk of side effects from tenofovir, such as kidney damage. If you need to take Harvoni with medications that contain tenofovir disoproxil fumarate, your doctor will monitor you more closely for side effects.
Examples of medications that contain tenofovir disoproxil fumarate include:
- tenofovir (Viread)
- tenofovir and emtricitabine (Truvada)
- tenofovir, elvitegravir, cobicistat, and emtricitabine (Stribild)
- tenofovir, emtricitabine, and rilpivirine (Complera)
Tipranavir and ritonavir
Taking Harvoni with the HIV medications tipranavir (Aptivus) or ritonavir (Norvir) can decrease levels of Harvoni in your body. This could make Harvoni less effective. Taking Harvoni with tipranavir and ritonavir isn’t recommended.
Cholesterol medications
Taking Harvoni with cholesterol medications called statins can increase the levels of statins in your body. This increases your risk of statin side effects, such as muscle pain and damage.
Statins include drugs such as rosuvastatin (Crestor), atorvastatin (Lipitor), and simvastatin (Zocor). If you take Harvoni with a statin, your doctor will monitor you closely for signs of rhabdomyolysis (muscle breakdown).
Rosuvastatin and Harvoni shouldn’t be taken together. Other statins should be used cautiously with Harvoni.
Warfarin
Harvoni may affect your body’s ability to form blood clots. If you need to take warfarin (Coumadin) while you’re being treated with Harvoni, your doctor may test your blood more often. They may also need to increase or decrease your warfarin dose.
Harvoni and ribavirin
There are no interactions between Harvoni and ribavirin (Rebetol). Harvoni is safe to take with ribavirin. In fact, Harvoni is approved by the FDA to be taken with ribavirin for people with certain medical histories.
Your doctor may prescribe ribavirin for you to take with Harvoni if you:
- have decompensated cirrhosis
- have had a liver transplant
- have had failed treatment with certain other hepatitis C medications in the past
Harvoni and ribavirin are used together in people with these conditions because clinical studies showed a higher cure rate with the combination treatment.
Harvoni and omeprazole or other PPIs
Taking Harvoni with omeprazole (Prilosec) or other proton pump inhibitors (PPIs) can decrease the amount of Harvoni in your body. This could make Harvoni less effective.
If possible, avoid taking Harvoni with this class of drugs. If you need a PPI while you’re taking Harvoni, you should take Harvoni and the PPI at the exact same time on an empty stomach.
Examples of other PPIs include:
- esomeprazole (Nexium)
- lansoprazole (Prevacid)
- pantoprazole (Protonix)
Harvoni and herbs and supplements
Taking Harvoni with St. John’s wort can decrease the amount of Harvoni in your body. This can make Harvoni less effective. To avoid this interaction, don’t take Harvoni with St. John’s wort.
Other herbs or supplements that may decrease the amount of Harvoni in your body include:
- kava kava
- milk thistle
- aloe
- glucomannan
During your treatment with Harvoni, check with your doctor before taking any new herbs or supplements.
Harvoni and coffee
There are no reported interactions between Harvoni and coffee. However, some of Harvoni’s side effects may be worsened if you consume too much coffee or caffeine. For instance, drinking coffee in the afternoon or evening could make your sleep problems worse. And caffeine can worsen headaches.
If you drink coffee or consume caffeine regularly, talk to your doctor about whether or not this is safe for you during your treatment with Harvoni.
Alternatives to Harvoni
Other drugs are available that can treat hepatitis C. Some may be better suited for you than others. If you’re interested in finding an alternative to Harvoni, talk to your doctor to learn more about other medications that may work well for you.
Hepatitis C can be treated using several other drugs or drug combinations. The drug treatment your doctor chooses for you will depend on your hepatitis C genotype, your liver function, and whether you have received treatment for hepatitis C in the past.
Examples of other drugs that may be used to treat hepatitis C include:
- Epclusa (velpatasvir, sofosbuvir)
- Mavyret (glecaprevir, pibrentasvir)
- Viekira Pak (paritaprevir, ombitasvir, ritonavir, dasubuvir)
- Vosevi (velpatasvir, sofosbuvir, voxilaprevir)
- Zepatier (elbasvir, grazoprevir)
- Rebetol (ribavirin), which is used in combination with other drugs
Interferons are older medications that were once commonly used to treat hepatitis C. However, the newer medications such as Harvoni cause fewer side effects and have higher cure rates than interferons. For these reasons, today interferons aren’t typically used to treat hepatitis C.
Harvoni vs. other drugs
You may wonder how Harvoni compares to other medications that are prescribed for similar uses. Below are comparisons between Harvoni and several medications.
Harvoni vs. Epclusa
Harvoni contains two drugs in one pill: ledipasvir and sofosbuvir. Epclusa also contains two drugs in one pill: velpatasvir and sofosbuvir.
Both medications contain the drug sofosbuvir, which is considered the “backbone” of the treatment. This means that the treatment plan is based on the backbone drug, with other drugs added in combination.
Uses
Harvoni and Epclusa are both FDA-approved to treat hepatitis C. Harvoni can treat hepatitis C genotypes 1, 4, 5, and 6, while Epclusa can treat all six genotypes.
Both drugs are approved to treat people without cirrhosis, or with compensated or decompensated cirrhosis. There are slight differences in who they are prescribed for, depending on genotype, liver function, and medical history.
Harvoni is FDA-approved to treat hepatitis C in children ages 12 and older or who weigh at least 77 pounds. Epclusa isn’t approved to treat hepatitis C in children.
Drug forms and administration
Harvoni and Epclusa are both taken as one tablet once daily. They can be taken with food or on an empty stomach.
The duration of treatment for Harvoni is either 8, 12, or 24 weeks. How long you take Harvoni will depend on your genotype, or type of hepatitis C and your liver function. It will also depend on your past hepatitis C treatments.
The duration of treatment for Epclusa is 12 weeks.
Side effects and risks
Harvoni and Epclusa are both drugs called direct-acting antivirals and have similar effects in the body. Because of this, they cause many of the same side effects. Below are some examples of these side effects.
More common side effects
More common side effects that can occur with both Harvoni and Epclusa include:
| Harvoni and Epclusa | Harvoni | Epclusa | |
| More common side effects |
|
|
(few unique common side effects) |
Serious side effects
Serious side effects that can occur with both Harvoni and Epclusa include:
- hepatitis B reactivation (when a previous infection becomes active again), which can lead to liver failure or death (see “Boxed warnings” below)
- serious allergic reactions, with symptoms that can include trouble breathing and angioedema (swelling under your skin, typically in your eyelids, lips, hands, or feet)
Boxed warnings
Harvoni and Epclusa both have a boxed warning from the FDA. A boxed warning is the strongest warning the FDA requires.
The warning describes a risk of hepatitis B reactivation after starting treatment with either drug. Reactivation of hepatitis B can lead to serious liver damage, liver failure, or death.
Your doctor will test you for hepatitis B before you start taking Harvoni or Epclusa. If you test positive for hepatitis B, you may need to take medication to treat it.
Effectiveness
According to treatment guidelines, Harvoni and Epclusa are both first-choice medication options for the treatment of hepatitis C genotypes 1, 4, 5, and 6. Additional recommendations include the following:
- Harvoni is a first-choice option for treating genotypes 1, 4, 5, and 6 in children ages 12 and older (or weighing 77 pounds and greater).
- Epclusa is a first-choice option for treating genotypes 2 and 3.
Harvoni and Epclusa have been compared in clinical studies. Both were found to be highly effective at curing hepatitis C. However, Epclusa may cure a greater percentage of people than Harvoni.
In one clinical study, more than 93 percent of people who received ledipasvir and sofosbuvir, the components of Harvoni, were cured of hepatitis C. The cure rate for people who received velpatasvir and sofosbuvir, the components of Epclusa, was greater than 97 percent.
A second study found similar results in people with compensated liver cirrhosis. Another study also found that Epclusa cured hepatitis C in a greater percentage of people than Harvoni.
In all three studies, the SVR was slightly higher for Epclusa than for Harvoni. SVR stands for sustained virologic response, which means that the virus can no longer be detected in your body.
Costs
Harvoni and Epclusa are both brand-name medications. There are currently no generic forms of either drug. Brand-name medications generally cost more than generics.
According to estimates on GoodRx.com, Harvoni is typically more expensive than Epclusa. The actual price you pay for either drug will depend on your insurance plan and the pharmacy you use.
Note: Generic versions of both drugs are expected to be released in early 2019. The manufacturer estimates that the cost for a course of each drug will be $24,000. This price is considerably less than the price of the brand-name versions.
Harvoni vs. Mavyret
Harvoni contains two drugs in one pill: ledipasvir and sofosbuvir. Mavyret also contains two drugs in one pill: glecaprevir and pibrentasvir.
Uses
Harvoni and Mavyret are both approved by the FDA to treat hepatitis C. However, they’re used to treat different genotypes in varying situations:
- Harvoni is approved to treat hepatitis C genotypes 1, 4, 5, and 6. Mavyret is approved to treat all six main genotypes.
- Both medications are used to treat people who have compensated cirrhosis. Harvoni can also be used in people with decompensated cirrhosis, but Mavyret can’t.
- Both can be used in people who have had a liver transplant.
- Mavyret can be used in people with severe kidney disease or after a kidney transplant, but Harvoni isn’t approved for these uses.
- Harvoni is approved to treat hepatitis C in children ages 12 and older or who weigh at least 77 pounds. Mavyret is only approved for use in adults.
- Both medications are approved to treat people who’ve tried certain hepatitis C medications in the past.
Drug forms and administration
Harvoni and Mavyret both come as tablets you take once per day. However, while you take one Harvoni tablet per day, you take three Mavyret tablets per day.
Harvoni can be taken with or without food, but Mavyret should be taken with a meal.
Harvoni may be prescribed for 8, 12, or 24 weeks of treatment. Mavyret’s treatment duration may be 8, 12, or 16 weeks. The length of treatment your doctor prescribes will be based on your hepatitis C genotype, liver function, and history of past hepatitis C treatments.
Side effects and risks
Harvoni and Mavyret have similar effects on the body. This means they also cause similar side effects. Below are examples of some of these side effects.
More common side effects
More common side effects that can occur with both Harvoni and Mavyret include:
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Serious side effects
Serious side effects that can occur with both Harvoni and Mavyret include:
- hepatitis B reactivation (when a previous infection becomes active again), which can lead to severe liver damage, liver failure, or death (see “Boxed warnings” below)
- serious allergic reaction, with symptoms that can include trouble breathing and angioedema (swelling under your skin, typically in your eyelids, lips, hands, or feet)
Boxed warnings
Harvoni and Mavyret both have boxed warnings from the FDA. A boxed warning is the strongest warning the FDA requires.
The warning describes a risk of hepatitis B reactivation after starting treatment with either drug. Hepatitis B reactivation can lead to serious liver damage, liver failure, or death.
Your doctor will test you for hepatitis B before you start taking Harvoni or Mavyret. If you test positive for hepatitis B, you may need to take medication to treat it.
Effectiveness
Harvoni and Mavyret haven’t been compared in clinical studies, but both are effective for treating hepatitis C.
According to treatment guidelines, Harvoni and Mavyret are both first-choice treatment options for hepatitis C genotypes 1, 4, 5, and 6. Mavyret is also a first-choice option for genotypes 2 and 3. In addition to these considerations, there are certain medical conditions where one drug would be recommended over the other:
- Children ages 12 and older or who weigh 77 pounds or more: Harvoni is a first-choice option for treating these children with genotypes 1, 4, 5, and 6. Mavyret isn’t recommended for use in children.
- Severe kidney disease: Mavyret is a first-choice option for treating hepatitis C in people with this condition. Harvoni isn’t recommended for people with severe kidney disease.
- Decompensated cirrhosis: For people with decompensated cirrhosis, Harvoni is recommended to be used with ribavirin. Mavyret isn’t recommended for people with this condition.
- Kidney transplant: For people who’ve received a kidney transplant, both drugs are recommended as a first-line option for people with genotypes 1 or 4. (Harvoni is used off-label for this purpose.) Mavyret is also recommended for people with genotypes 2, 3, 5, or 6 who’ve had a kidney transplant, but Harvoni isn’t.
- Liver transplant: Treatment recommendations for use of Harvoni and Mavyret are different for people with a liver transplant. They are based on genotype and liver function.
Costs
Harvoni and Mavyret are both brand-name medications. There are currently no generic forms of either drug available. Brand-name medications usually cost more than generics.
According to estimates on GoodRx.com, Harvoni is typically much more expensive than Mavyret. The actual cost you pay for either drug will depend on your insurance plan and the pharmacy you use.
Note: A generic version of Harvoni is expected to be released in early 2019. The manufacturer estimates the cost for a course of the drug will be $24,000. This price is considerably less than the price of the brand-name version.
Harvoni vs. Sovaldi
Harvoni and Sovaldi are both used to treat hepatitis C. Harvoni is a combination tablet that contains two drugs: ledipasvir and sofosbuvir. Sovaldi contains one drug: sofosbuvir.
Uses
Harvoni is FDA-approved to treat hepatitis C in adults with genotypes 1, 4, 5, or 6. It can also be used to treat children with these genotypes who are aged 12 and up or who weigh at least 77 pounds.
Sovaldi is also approved to treat hepatitis C, but it’s used in adults with genotypes 1, 2, 3, or 4. It can also be used in children with genotypes 2 or 3 who are 12 years or older or who weigh 77 pounds or more.
Sovaldi is used in combination with other medications to treat hepatitis C. It’s not FDA-approved to be used by itself.
Drug forms and administration
Harvoni and Sovaldi both come as tablets you take by mouth. Harvoni is taken once daily for 8, 12, or 24 weeks. Sovaldi is also taken once daily, but for 12 or 24 weeks.
Both medications contain sofosbuvir, but Harvoni is a combination medication that can be used by itself for some people. Sovaldi isn’t used by itself to treat hepatitis C. It’s prescribed with other drugs, including pegylated interferon and ribavirin (Rebetol). The generic form of Sovaldi is also found in other combination hepatitis C medications.
Side effects and risks
Both medications contain sofosbuvir, so they will cause many of the same side effects. However, Sovaldi is always taken in combination with other medications, which may work differently from Harvoni. Because of this, the side effects seen with Sovaldi treatment depend on the drug it’s used with.
Common and serious side effects for Harvoni and Sovaldi are shown below. The Sovaldi side effects described are seen when Sovaldi is used with other hepatitis C drugs such as ribavirin and pegylated interferon.
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* Harvoni and Sovaldi both have a boxed warning from the FDA for hepatitis B reactivation. A boxed warning is the strongest warning the FDA requires. It alerts doctors and patients about drug effects that may be dangerous.
Effectiveness
Harvoni and Sovaldi have different FDA-approved uses, but they’re both used to treat hepatitis C. Harvoni is effective against the virus when used alone or with ribavirin. Sovaldi is effective at treating hepatitis C only when used in combination with other drugs, such as ribavirin and pegylated interferon.
According to treatment guidelines, Harvoni is a first-choice option to treat hepatitis C in people with genotypes 1, 4, 5, or 6. It’s also a first-choice option in children ages 12 and older or who weigh at least 77 pounds.
Sovaldi is no longer recommended by treatment guidelines as a first-choice option to treat hepatitis C. This is because newer drugs such as Harvoni are considered more effective. The newer drugs also cause fewer serious side effects.
However, Sovaldi is sometimes recommended as a second-choice treatment for certain people, but it has to be used in combination with other medications.
Costs
Harvoni and Sovaldi are brand-name medications. There are currently no generic forms available of either drug.
According to estimates on GoodRx.com, Harvoni typically costs slightly more than Sovaldi. The actual price you pay for either drug will depend on your insurance and the pharmacy you use.
Note: A generic version of Harvoni is expected to be released in early 2019. The manufacturer estimates the cost for a course of the drug will be $24,000. This price is considerably less than the price of the brand-name version.
Harvoni vs. Zepatier
Harvoni contains the drugs ledipasvir and sofosbuvir in one pill. Zepatier also contains two drugs in one pill: elbasvir and grazoprevir.
Uses
Harvoni and Zepatier are both FDA-approved to treat hepatitis C virus in adults with genotypes 1 or 4. Harvoni is also approved for treating genotypes 5 and 6 in adults, and genotypes 1, 4, 5, or 6 in children ages 12 or older or who weigh at least 77 pounds. Zepatier isn’t approved for use in children.
Harvoni is approved to treat hepatitis C virus in adults with decompensated cirrhosis or who’ve had a liver transplant. With these conditions, your doctor will likely prescribe ribavirin with Harvoni.
Zepatier isn’t approved for use in people with moderate or severe liver disease, decompensated cirrhosis, or after a liver transplant.
Zepatier is FDA-approved for use in people with genotypes 1 and 4 who have a condition called polymorphism. With this condition, a person has certain genetic variations (mutations) that make the virus resistant to certain medications. When a virus is resistant, it’s difficult to treat with certain drugs.
Your doctor will perform a blood test see if you have one of these variations. If you do, you may need to take ribavirin with Zepatier.
Drug forms and administration
Harvoni and Zepatier both come as a single tablet that’s taken once daily. Each can be taken with or without food.
Harvoni treatment lasts for 8, 12, or 24 weeks. Zepatier treatment lasts for 12 or 16 weeks. The duration of treatment your doctor prescribes will be based on your genotype, liver function, and history of past hepatitis C treatments.
Side effects and risks
Harvoni and Zepatier are similar medications and their effects on the body are alike. Therefore, they cause many of the same side effects. Below are some examples of their side effects.
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* Harvoni and Zepatier both have a boxed warning from the FDA for hepatitis B reactivation. A boxed warning is the strongest warning the FDA requires. It alerts doctors and patients about drug effects that may be dangerous.
Effectiveness
Harvoni and Zepatier haven’t been compared in clinical studies, but both are effective for treating hepatitis C.
According to treatment guidelines, both Harvoni and Zepatier are recommended as first-choice options to treat hepatitis C in adults with genotypes 1 and 4. Harvoni is also a first-choice option for treating genotypes 5 and 6, but Zepatier isn’t.
Guideline recommendations for Harvoni and Zepatier also differ in the following conditions:
- Children ages 12 and older or who weigh 77 pounds or more: Harvoni is a first-choice option for treating these children who have genotypes 1, 4, 5, and 6. Zepatier isn’t recommended for use in children.
- Severe kidney disease: Zepatier is recommended as a first-choice option for people with this condition, while Harvoni isn’t.
- Decompensated cirrhosis: In people with decompensated cirrhosis, Harvoni is recommended as a first-choice option. Zepatier isn’t recommended for people with this condition.
- Liver or kidney transplant: Harvoni is a first-choice option for treating hepatitis C in people who’ve had a liver or kidney transplant. Zepatier isn’t recommended for people with these conditions.
Costs
Harvoni and Zepatier are brand-name medications. There are currently no generic forms available for either drug. Brand-name medications usually cost more than generics.
According to estimates on GoodRx.com, Harvoni typically costs much more than Zepatier. The actual cost you pay for either drug will depend on your insurance plan and the pharmacy you use.
Note: A generic version of Harvoni is expected to be released in early 2019. The manufacturer estimates the cost for a course of the drug will be $24,000. This price is considerably less than the price of the brand-name version.
How to take Harvoni
You should take Harvoni according to your doctor’s instructions.
Timing
Harvoni can be taken at any time of the day. However, you should try to take Harvoni at the same time every day. This can help you remember to take it and help keep a consistent amount of the drug in your system.
If you experience fatigue during your treatment with Harvoni, try taking the drug at night. That might help you avoid that side effect.
Taking Harvoni with food
Harvoni can be taken with or without food. If you experience nausea after taking Harvoni, you may avoid that side effect by taking the drug with food.
Can Harvoni be crushed?
It’s not known whether it’s safe to crush Harvoni tablets, so it’s best to avoid crushing them. If you have trouble swallowing Harvoni tablets, talk with your doctor about other medications that may work better for you.
How Harvoni works
Harvoni is used to treat infection with the hepatitis C virus (HCV).
About hepatitis C
HCV is transmitted through blood or body fluids. The virus primarily attacks cells in your liver and causes inflammation. This leads to symptoms such as:
- pain in your abdomen (belly)
- fever
- dark-colored urine
- joint pain
- jaundice (yellowing of your skin or the whites of your eyes)
Some people’s immune systems can fight HCV without treatment. However, many people need medication to clear the virus and reduce long-term effects. Serious, long-term effects of hepatitis C include cirrhosis (liver scarring) and liver cancer.
How does Harvoni treat hepatitis C?
Harvoni is a direct-acting antiviral (DAA). These types of drugs treat HCV by stopping the virus from reproducing (making copies of itself). Viruses that can’t make copies eventually die and are cleared from the body.
Clearing the virus from your body will decrease liver inflammation and prevent additional liver scarring.
How long does it take to work?
Some people start feeling better within a few days or weeks of starting treatment with Harvoni. However, you’ll still need to take Harvoni for the entire time that your doctor prescribes.
In clinical studies, more than 86 percent of people who took Harvoni were cured after three months of treatment.
Your doctor will test your blood for the virus before and during treatment. They will also test it 12 weeks after you finish treatment. If there is no detectable virus in your body 12 weeks after your treatment ends, you have achieved sustained virologic response (SVR). Achieving SVR means you’re considered cured of hepatitis C.
Harvoni and pregnancy
There haven’t been enough studies in humans to know if Harvoni is safe to take during pregnancy. In animal studies, there was no harm to the fetus seen when the mother received Harvoni. However, animal studies don’t always predict what will happen in humans.
If you’re pregnant or planning to become pregnant, talk to your doctor about whether Harvoni is right for you.
Note: If you’re taking Harvoni with ribavirin, that treatment isn’t safe to use during pregnancy (see “Harvoni and ribavirin” above).
Harvoni and breastfeeding
It isn’t known if Harvoni passes into human breast milk. In animal studies, Harvoni was found in breast milk but didn’t cause harmful effects in offspring. However, animal studies don’t always predict what will happen in humans.
If you’re breastfeeding or planning to breastfeed, talk with your doctor about the potential risks and benefits of taking Harvoni while breastfeeding.
Note: If you’re taking Harvoni with ribavirin, you should talk to your doctor about whether you can safely continue to breastfeed (see “Harvoni and ribavirin” above).
Common questions about Harvoni
Here are answers to some frequently asked questions about Harvoni.
Do I need to follow a special diet while taking Harvoni?
No, there is no special diet required while you take Harvoni.
However, if you experience nausea or stomach pain as a side effect of Harvoni, it may be helpful to eat smaller meals and avoid foods that are greasy, spicy, or acidic. Taking Harvoni with a small snack may also lessen nausea.
How long will Harvoni take to get rid of my hepatitis C?
Harvoni will start working right away to fight the virus. However, in order to get rid of hepatitis C, you will need to take Harvoni for the full length of time that your doctor prescribes. This may be 8, 12, or 24 weeks, depending on your medical history.
In clinical studies, nearly all people who took Harvoni achieved sustained virologic response SVR) after the full treatment. SVR means that the virus was no longer detectable in their blood. When a person achieves SVR, they are considered cured of hepatitis C.
What is the cure rate for Harvoni?
The cure rate for Harvoni depends on certain aspects of your hepatitis C. This includes whether or not you have cirrhosis, what hepatitis C treatments you have tried in the past, and what genotype of the virus you have.
For example, in clinical studies of Harvoni, 96 percent of people who met the following description were cured of hepatitis C after 12 weeks:
- had genotype 1
- had no cirrhosis
- had no history of other hepatitis C treatments
In the same clinical studies, between 86 percent and 100 percent of people with different medical histories were cured of hepatitis C.
Can hepatitis C come back after taking Harvoni?
If you take Harvoni every day as directed by your doctor and you maintain a healthy lifestyle, the virus shouldn’t return.
However, it’s possible to relapse (have the infection reappear). This happens when a medication has cured a person of hepatitis C, but blood tests detect the virus again months to years after treatment. In clinical trials, up to 6 percent of people treated with Harvoni had a relapse.
Also, if you’re exposed to hepatitis C again after you take any hepatitis C medication, including Harvoni, you can become reinfected with the virus. Reinfection can occur in the same way the original infection was contracted.
Sharing needles used for injecting drugs and having intercourse without a condom are possible routes of reinfection. Avoiding these behaviors can help prevent reinfection with hepatitis C.
What is a hepatitis C genotype?
There are six different strains, or types, of hepatitis C viruses that are known to infect people. These strains are called genotypes.
Genotypes are identified by differences in the genetic code of the viruses. The most common hepatitis C strain in the United States is genotype 1, but other strains are also seen here.
Your doctor will give you a blood test to determine which genotype you have. Your hepatitis C genotype will help your doctor decide which medication is right for you.
Harvoni overdose
If you take too much Harvoni, you increase your risk of serious side effects.
Overdose symptoms
Symptoms of an overdose of Harvoni can include:
- fatigue
- severe headache
- nausea and vomiting
- muscle weakness
- insomnia (trouble sleeping)
- irritability
What to do in case of overdose
If you think you’ve taken too much of this drug, call your doctor or seek guidance from the American Association of Poison Control Centers at 800-222-1222 or through their online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.
Harvoni warnings
This drug comes with several warnings.
FDA warning: Reactivation of hepatitis B virus
This drug has a boxed warning. This is the most serious warning from the Food and Drug Administration (FDA). A boxed warning alerts doctors and patients about drug effects that may be dangerous.
- When people who are coinfected with both hepatitis C and hepatitis B start taking Harvoni, there is a risk of reactivation of the hepatitis B virus (HBV). Reactivation means the virus becomes active again. Reactivation of HBV can lead to liver failure or death. Your doctor will test you for HBV before you start treatment with Harvoni. If you’re found to have HBV, you may need to take medication to treat it.
Other warnings
Before taking Harvoni, talk with your doctor about your health history. Harvoni may not be right for you if you have certain medical conditions.
It’s not known if Harvoni is safe or effective in people with severe kidney disease. This includes people with severe kidney impairment or with end-stage kidney disease that requires hemodialysis. However, people with severe kidney disease who took Harvoni in a 2018 clinical study were treated effectively and had no severe negative effects.
If you have severe kidney disease, talk to your doctor about whether Harvoni is right for you.
Harvoni expiration
When Harvoni is dispensed from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically one year from the date the medication was dispensed.
The purpose of such expiration dates is to guarantee the effectiveness of the medication during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications.
How long a medication remains good can depend on many factors, including how and where the medication is stored. Harvoni tablets should be stored below 86⁰F (30⁰C) and kept in the container they came in.
If you have unused medication that has gone past its expiration date, talk to your pharmacist about whether you might still be able to use it.
Professional information for Harvoni
The following information is provided for clinicians and other healthcare professionals.
Mechanism of action
Harvoni contains two drugs: ledipasvir and sofosbuvir.
Ledipasvir inhibits HCV NS5A protein, which is required for efficient phosphorylation of viral RNA. Inhibition of NS5A blocks RNA replication and assembly.
Sofosbuvir is an HCV NS5B polymerase inhibitor with an active metabolite (a nucleoside analog triphosphate) that is incorporated into HCV RNA. The active metabolite acts as a chain terminator, halting HCV replication.
Harvoni has activity against HCV genotypes 1, 4, 5, and 6.
Pharmacokinetics and metabolism
Harvoni contains two active ingredients: ledipasvir and sofosbuvir.
Ledipasvir reaches peak concentration in about four hours and is almost completely bound to plasma proteins. Metabolism occurs via oxidation through an unknown mechanism. The half-life is about 47 hours. The unchanged drug and its oxidative metabolites are eliminated primarily in the feces.
Sofosbuvir’s peak concentration occurs in 45 minutes to one hour. Plasma protein binding accounts for approximately 65 percent of circulating drug. Sofosbuvir is a prodrug that is converted to an active metabolite (GS-461203) by hydrolysis and phosphorylation in the liver. GS-461203 is further dephosphorylated to an inactive metabolite.
Up to 80 percent of the dose is eliminated in the urine. The parent drug’s half-life is 30 minutes, and the inactive metabolite’s half-life is around 27 hours.
Contraindications
There are no contraindications to Harvoni use. Refer to ribavirin prescribing information for contraindications for people receiving Harvoni with ribavirin.
Storage
Harvoni should be stored in its original container at temperatures lower than 86⁰F (30⁰C).
Disclaimer: MedicalNewsToday has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.