I'm tired, losing hair and gained 25 pounds in 8 weeks of hepatitis C treatment with Harvoni. Is this normal? - HepHarvoni (ledipasvir/sofosbuvir) Harvoni is a brand-name prescription drug used to treat hepatitis C. Harvoni contains two medicines: ledipasvir and sofosbuvir. It comes as a tablet that is normally taken once a day for 12 weeks. Harvoni is a type of medication called direct action antiviral (ADA). 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 most Harvoni, the success rate to cure hepatitis C was greater than 90 percent. This means that almost all people who took Harvoni achieved a sustained virological response (SVR). SVR means that they had not detected viruses in their body 12 weeks or more after treatment ended. Harvoni contains two medications in a tablet: ledipasvir and sofosbuvir. There are currently no generic forms of drug combination or individual drugs. Harvoni is only available as a prescription brand medication. However, a Harvoni is expected to be released early in 2019. Harvoni can cause mild or severe side effects. The following list contains some of the key side effects that can occur when taking Harvoni. This list does not include all possible side effects. For more information on the possible side effects of Harvoni or advice on how to deal with a worrying side effect, talk to 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.) Most Common Side Effects Harvoni's most common side effects may include: In some cases, Harvoni may cause a mild allergic reaction. Symptoms may include skin rash, itching and spraying (skin baldness and redness, typically on the face and neck). Most of these side effects may disappear within a few days or a couple of weeks. If you are more severe or do not go away, talk to your doctor or pharmacist. Serious Side Effects Harvoni's severe side effects are not common, but may occur. Call your doctor immediately 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 symptoms may include the following: Suicide prevention Long-term side effects Long-term side effects have not been reported with the use of Harvoni. However, people with cirrhosis (liver cancer) may still have symptoms of liver damage after 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 has not been reported in clinical trials. However, after finishing treatment with Harvoni, some people may experience flu-like symptoms such as muscle aches, chills, fatigue, and sleep problems. These side effects are probably caused by recovery of your body after the hepatitis C virus is cleaned. If you have flu-like symptoms after you finish your treatment with Harvoni, talk to your doctor. Weight loss or weight gainWeight changes during Harvoni treatment were not reported in clinical studies. However, some people have lost weight as a symptom of hepatitis C. If you have serious weight changes, talk to your doctor. Retirement symptoms Stop treatment with Harvoni has not caused withdrawal symptoms in clinical trials. Some people may experience symptoms that resemble withdrawal, such as flu fever, headache, and muscle aches. However, it is not clear whether these symptoms are related to stopping the treatment of Harvoni. Joint painThe pain was not a side effect of Harvoni in clinical trials. Many people with hepatitis C experience joint pain as a symptom of the virus, however. This may be the result of chronic inflammation or an autoimmune process that attacks your joints. If you are having pain in your joints, talk to your doctor about ways to handle it. Ocular Effects In Harvoni, people taking the drug did not experience eye problems. But there's one after using Harvoni with the ribavirin of the drug. And another person after using sofosbuvir (one of the medications in Harvoni) and ribavirin. However, it is not clear whether Harvoni or its ingredients caused eye problems in these cases. In addition, it was found that these same drugs did not cause eye problems in people with hepatitis C.In any case, if you experience any eye effect while taking Harvoni, talk to your doctor immediately. Hair Loss Hair loss was not reported as a side effect in Harvoni clinical studies. Some people have reported losing their hair while taking the medication, but it is not clear whether Harvoni was the cause of their hair loss. It is important to note that hair loss can be a symptom of hepatitis C. Hepatitis C (VH) virus prevents your liver from working properly. You need a healthy liver to get nutrients from the food you eat. So if you can't get the nutrients your body needs, you can experience hair loss. If you're worried about hair loss, talk to your doctor. Rash/itchingSkin rashes were reported in some people who took Harvoni in, but it is unclear how common they were. In some cases, people also had blisters and swelling of the skin. These can be caused by allergic reactions to Harvoni. Spicy skin and rashes are also symptoms of hepatitis C virus. Besides, they can be signs of severe liver damage. Talk to your doctor if you are experiencing rash or irritating spicy skin. Diarrhea In Harvoni, between 3% and 7% of people experienced diarrhea during treatment. Diarrhea may disappear with the continued use of the medication. If you have severe diarrhea or diarrhea that lasts longer than a couple of days, talk to your doctor immediately. DepressionDepression is a rare side effect of Harvoni. In , less than 5 percent of the people who took Harvoni experienced depression. In addition, suicidal thoughts occurred in less than 1 percent of the people who took Harvoni with ribavirin or interferon/ribavirin pegilado. Many people with hepatitis C may feel depressed by their diagnosis. If you feel depressed, talk to your doctor about ways to improve your mood. And if you have thoughts of hurting yourself, call your doctor right away. Fatigue Fatigue, or lack of energy, is a common side effect of Harvoni. In , up to 18 percent of the people who took Harvoni experienced fatigue. Fatigue can disappear with the continued use of Harvoni. However, if your fatigue is severe and affects your life, talk to your doctor. Insomnia (sleep) In , insomnia occurred in up to 6 percent of the people who took Harvoni. This side effect can be eliminated with the continued use of the medication. Ways to improve your dream include following a regular sleep schedule and keeping the electronics, such as smartphones, outside your bedroom. If your insomnia is upset and does not go away, talk to your doctor about other ways to help you sleep. HeadacheHeadache is a common side effect of Harvoni. In , up to 29 percent of the people who took Harvoni experienced headaches. If you are having headaches while taking Harvoni, talk to your doctor about ways to help you handle them. Harvoni liver cancer is a medication called direct action antiviral (ADA). Treating hepatitis C with DAAs helps prevent long-term effects such as liver cancer. However, there has been liver cancer in people who had been cured of hepatitis C with Harvoni treatment. One found that people with cirrhosis who were treated with an ASD had a higher risk of developing liver cancer compared to people without cirrhosis. However, people without cirrhosis may still have liver cancer. If you are concerned about your risk of developing liver cancer, talk to your doctor. As with all medicines, the cost of Harvoni can vary. 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 help to understand your insurance coverage, help is available. Gilead Sciences, Inc., the Harvoni manufacturer, offers a program called Harvoni Support Path. For more information and to know if you are eligible for support, call 855-769-7284 or visit . The Food and Drug Administration (FDA) approves prescription drugs such as Harvoni to treat certain conditions. Harvoni is approved by the FDA for the treatment of hepatitis C virus (HV). Harvoni can be prescribed for: This table illustrates who is eligible for Harvoni treatment: Genotype 1Genotype 2Genotype 3Genotype 4Genotype 5 6No cirrhosisYYYYYYYYYYYYYYCirrosis decompensatedY (only adults)Group transplant receiverY (only adults) In certain situations, your doctor may prescribe a second medication to take with Harvoni. For example, ribavirin (Rebetol) can be prescribed in combination with Harvoni. This can happen if you have decompensated cirrhosis (severe symptoms of advanced liver disease) or if you have taken certain medicines to treat hepatitis C in the past. Its ribavirin dose would depend on its weight, kidney function and other health conditions. The following information describes the recommended dose of Harvoni. Forms and strengths of Harvoni drugs is available in one force. It comes in a combined tablet containing 90 mg of ledipasvir and 400 mg of sofosbuvir. Hepatitis dose CThe dose to treat hepatitis C is a tablet (90 mg ledipasvir/400 mg sofosbuvir), taken once a day. Duration of treatment The time taken by Harvoni will depend on your hepatitis C genotype (virus training). It will also depend on your liver function, and any treatment of hepatitis C you have tested in the past. Most people take Harvoni for 12 weeks, but treatment can also last 8 or 24 weeks. Your doctor will determine the correct length of treatment for you. What if I miss a dose? It is important to take Harvoni every day for as long as your doctor prescribes. Missing or jumping doses can make the virus resistant to Harvoni. Resisting means that the drug doesn't work for you anymore. Using a reminder tool can help you remember to take Harvoni every day. If you forget a dose, take it as soon as you remember it. If you do not remember until the next day, do not take two doses of Harvoni immediately. This may increase the risk of side effects. Take your regular dose of Harvoni. It is extremely important to take your Harvoni tablets exactly as your doctor prescribes. This is because after your treatment plan you increase your chances of healing your hepatitis C (HCV). It also helps to reduce the risk of long-term effects of HV, including cirrhosis and liver cancer. Lost doses can make Harvoni less effective in treating your HCV. In some cases, if you lose your dose, your HCV may not be cured. Be sure to follow your doctor's instructions and take a Harvoni tablet every day for the full duration of your treatment. Using a reminder tool can help you make sure you take Harvoni every day. If you have any questions or concerns about your treatment, talk to your doctor. They can help solve any problems for you and help you get the most effective treatment for your hepatitis C. Drinking alcohol while taking Harvoni can increase the risk of certain side effects of Harvoni. These side effects include: In addition, both hepatitis C and excessive alcohol use cause scarring and inflammation in the liver. Combining both increases the risk of cirrhosis and liver failure. Alcohol can also make you less able to take your medication as indicated by your doctor. For example, it may cause you to forget to take your medication at the right time. Harvoni's missed doses could make it less effective in treating your HCV. For all these reasons, you should avoid drinking alcohol when you have hepatitis C. This is especially true when dealing with Harvoni. If you have problems avoiding alcohol, talk to your doctor. Harvoni is usually taken on his own to treat hepatitis C. However, in some cases, it is taken with another medication called ribavirin (Rebetol). Your doctor may prescribe ribavirin with Harvoni if you:Harvoni and ribavirin are used together in people in these situations because they showed a higher healing rate with the combined treatment than with Harvoni alone. Treatment with ribavirin usually lasts 12 weeks. Ribavirin comes as a pill 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. Side effects of ribavirinThe rhyme can cause several common and severe side effects. He also comes with important warnings. Warning in boxRibavirin has one of the FDA. A box warning is the strongest kind of warning that the FDA requires. Ribavirin's warning advises that: Other side effects Rimavirine may also cause some common side effects, such as: Serious but severe side effects seen in anemia, lung disease, and pancreatitis included. They also included eye problems, such as infections and blurred vision. Ribavirin and PregnancySee "Accessful" above. Ribavirin and breastfeeding It is not known whether ribavirin passes to human breast milk. Animal studies show that the ribavirin taken by the mother could be harmful to young nurses. However, animal studies do not always predict what will happen in humans. If you are considering the treatment of ribavirin while breastfeeding, talk to your doctor. They may recommend that you stop breastfeeding or avoid the treatment of ribavirin. Harvoni can interact with several other medicines. You can also interact with certain supplements and foods. Different interactions can cause different effects. For example, some may interfere with how well a medication works, while others may cause higher side effects. Harvoni and other medicines Below is a list of medicines that can interact with Harvoni. This list does not contain all medicines that can interact with Harvoni. Before taking Harvoni, be sure to tell your doctor and pharmacist about all prescriptions, free sale and other medicines you take. Also tell them about any vitamins, herbs and supplements you use. Sharing this information can help you avoid possible interactions. If you have questions about drug interactions that may affect you, ask your doctor or pharmacist. AcidsTaking 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 dosage from Harvoni and antiacids for at least four hours. H2 Havoni blockers with medications called H2 blockers can decrease the amount of Harvoni that is absorbed in your body. This can make Harvoni less effective in fighting the hepatitis C virus. If you need to take an H2 blocker with Harvoni, you should take them at the same time or take them for 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 begin. Taking them 12 hours away also allows each medication to be absorbed by your body without interacting with the other medication. Examples of H2 blockers include famotidine (Pepcid) and cymetidine (Tagamet HB). AmiodaroneTomar Harvoni with amiodarone (Pacerone, Nexterone) can cause a dangerously slow heart rate, called bradycardia. Some reports have claimed that people who took amiodarone and Harvoni together needed pacemakers to maintain a regular heart rate. They also reported that other people had a fatal heart attack. Taking amiodarone and Harvoni together is not recommended. If you have to take Harvoni and amiodarone together, your doctor will closely monitor your heart function. digoxinTake Harvoni with digoxin (Lanoxin) can increase the amount of digoxin in your body. Too high digoxin levels can lead to dangerous side effects. If you need to take Harvoni and digoxin together, your doctor will closely monitor your digoxin levels. They can change your dose of digoxin to reduce the risk of side effects. Taking Harvoni with certain seizure medications may decrease the amount of Harvoni your body absorbs. This can reduce Harvoni's effectiveness. For this reason, you should not take Harvoni with these seizure medications. Examples of medicines for seizure to avoid while taking Harvoni include: Antibiotics Antibiotics Medicines against antibiotics may decrease Harvoni levels in your body. This can make Harvoni less effective. To prevent this interaction, avoid taking Harvoni with the following antibiotics: HIV medicines Taking Harvoni with certain HIV medicines can change the levels of your Harvoni body or HIV medications. These interactions can make medicines less effective or increase the risk of side effects. Tenofovir disoproxil fumarateTaking Harvoni with medicines that contain tenofovir disoproxil fumarate can increase tenofovir levels in your body. This will increase the risk of side effects of tenofovir, such as kidney damage. If you need to take Harvoni with medicines that contain tenofovir disoproxil fumarate, your doctor will monitor you more closely for side effects. Examples of medications containing tenofovir disoproxil fumarate include: Tipranavir and ritonavirTake Harvoni with medicines for HIV tipranavir (Aptivus) or ritonavir (Norvir) may decrease Harvoni levels in your body. This could make Harvoni less effective. It is not recommended to take Harvoni with tipranavir and ritonavir. Medications Cholesterol Taking Harvoni with cholesterol medications called statins can increase statin levels in your body. This increases the risk of side effects of statin, 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 to detect signs of rhabdomiolysis (muscular breakdown). Rosuvastatin and Harvoni should not be taken together. Other statins should be used cautiously with Harvoni. Warfarin Harvoni can affect your body's ability to form blood clots. If you need to take warfarin (Coumadin) while you are dealing with Harvoni, your doctor can try your blood more often. They may also need to increase or decrease the dose of warfarin. Harvoni and ribavirin There are no interactions between Harvoni and ribavirin (Rebetol). Harvoni is safe to drink with ribavirin. In fact, Harvoni is approved by the FDA to be taken with ribavirin for people with certain medical stories. Your doctor may prescribe ribavirin for you to take with Harvoni if you: Harvoni and ribavirin are used in people with these conditions because clinical trials showed a higher healing rate with the combined treatment. Harvoni and omeprazole or other PPIsTomar Harvoni with omeprazole (Prilosec) or other proton pump inhibitors (PPIs) may decrease the amount of Harvoni in your body. This could make Harvoni less effective. If possible, avoid taking Harvoni with this kind of drugs. If you need a PPI while taking Harvoni, you should take Harvoni and PPI at the same time in an empty stomach. Examples of other PPIs are:Harvoni and herbs and supplements Take Harvoni with the herb of San Juan can decrease the amount of Harvoni in your body. This can make Harvoni less effective. To avoid this interaction, do not take Harvoni with St. John's grass. Other herbs or supplements that may decrease the amount of Harvoni in your body include: During your treatment with Harvoni, consult your doctor before taking new herbs or supplements. Harvoni and coffee There are no interactions reported between Harvoni and coffee. However, some of the side effects of Harvoni may get worse if you consume too much coffee or caffeine. For example, drinking coffee in the afternoon or at night could make sleep problems worse. And caffeine can make headaches worse. If you drink coffee or eat caffeine regularly, talk to your doctor about whether this is safe for you during your treatment with Harvoni. Other medicines are available that can treat hepatitis C. Some may be more suitable for you than others. If you are interested in finding an alternative to Harvoni, talk to your doctor to learn more about other medicines that can work well for you. Hepatitis C can be treated using several other drugs or combinations of drugs. Drug treatment your doctor chooses for you will depend on your hepatitis C genotype, your liver function, and if you have received treatment for hepatitis C in the past. Examples of other drugs that can be used to treat hepatitis C include: Interferons are older medicines that were used once commonly to treat hepatitis C. However, the most recent medicines such as Harvoni cause less side effects and have higher healing rates than interferons. For these reasons, today interferons are not normally used to treat hepatitis C.You may wonder how Harvoni is compared to other medicines that are prescribed for similar uses. Comparisons between Harvoni and several medicines are presented below. Harvoni vs. EpclusaHarvoni contains two medications in a pill: ledipasvir and sofosbuvir. Epclusa also contains two medications in a pill: velpatasvir and sofosbuvir. Both medications contain sofosbuvir medication, which is considered the "steel" of the treatment. This means that the treatment plan is based on the spine medication, with other medicines added in combination. UsesHarvoni and Epclusa are both approved by FDA to treat hepatitis C. Harvoni can treat hepatitis C geneotypes 1, 4, 5 and 6, while Epclusa can treat the six genotypes. Both medicines are approved to treat people without cirrhosis, or with compensated or decompensated cirrhosis. There are small differences in which they are prescribed, depending on the genotype, liver function and medical history. Harvoni is approved by the FDA to treat hepatitis C in children over 12 years of age or at least 77 pounds. Epclusa is not approved to treat hepatitis C in children. Forms and administration of Harvoni and Epclusa drugs are taken as a tablet once a day. They can be taken with food or empty stomach. The length of treatment for Harvoni is 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 previous hepatitis C treatments. The length of treatment for Epclusa is 12 weeks. Side effects and risks Harvoni and Epclusa are both drugs called direct action antivirals and have similar effects on the body. Because of this, they cause many of the same side effects. Below are some examples of these side effects. Most common side effects Most common side effects that can occur with Harvoni and Epclusa include:Harvoni and EpclusaHarvoniEpclusa Most common side effects (without single common side effects) Serious side effects Serious side effects that may occur with Harvoni and Epclusa include: Harvoni and Epclusa box warnings both have a FDA box warning. A box warning is the strongest warning required by the FDA. The warning describes a risk of reactivation of hepatitis B after starting treatment with both drugs. The reactivation of hepatitis B may cause severe liver damage, liver failure or death. Your doctor will test you for hepatitis B before you start taking Harvoni or Epclusa. If positive test for hepatitis B, you may need to take medications to treat it. Effectiveness According to , Harvoni and Epclusa are the first choice drug options for the treatment of hepatitis C genotypes 1, 4, 5 and 6. Other recommendations include: Harvoni and Epclusa have been compared to clinical studies. Both found themselves very effective in healing hepatitis C. However, Epclusa can cure a greater percentage of people than Harvoni. In one, more than 93 percent of people who received ledipasvir and sofosbuvir, Harvoni components were cured of hepatitis C. The healing rate for people who received velpatasvir and sofosbuvir, the components of Epclusa, was higher than 97 percent. Similar results were found in people with compensated liver cirrhosis. He also found that Epclusa cured hepatitis C in a higher percentage of people than Harvoni. In the three studies, the SVR was slightly higher for Epclusa than for Harvoni. SVR represents a sustained virological response, which means that the virus can no longer be detected in your body. CostsThe Harvoni and Epclusa are both brand-name drugs. There are currently no generic forms of either drug. Brand-name drugs usually cost more than generics. According to estimates of , Harvoni is usually more expensive than Epclusa. The real price you pay for any medication will depend on your insurance plan and the pharmacy you use. Note: Both drugs are expected to be released early in 2019. The manufacturer estimates that the cost for a course of each medication will be $24,000. This price is considerably lower than the price of brand versions. Harvoni vs. MavyretHarvoni contains two medications in a pill: ledipasvir and sofosbuvir. It also contains two medications in a pill: glecaprevir and pibrentasvir. UsesHarvoni and Mavyret are both approved by the FDA to treat hepatitis C. However, they are used to treat different genotypes in varying situations: Harvoni and Mavyret forms and administration come as tablets you take once a day. However, while taking a Harvoni tablet per day, take three Mavyret tablets per day. Harvoni can be taken with or without food, but Mavyret should be taken with a meal. Harvoni can be prescribed for 8, 12 or 24 weeks of treatment. The duration of Mavyret treatment may be 8, 12 or 16 weeks. The length of treatment prescribed by your doctor will be based on your hepatitis C genotype, liver function, and prior hepatitis C treatments. Side effects and risks Harvoni and Mavyret have similar effects on the body. This means that they also cause similar side effects. Examples of some of these side effects are presented below. Most common side effects Most common side effects that may occur with Harvoni and Mavyret include: Harvoni and MavyretHarvoniMavyret Most common side effects Serious side effects Serious side effects that may occur with Harvoni and Mavyret include: Harvoni and Mavyret box warnings have boxed FDA warnings. A box warning is the strongest warning required by the FDA. The warning describes a risk of reactivation of hepatitis B after starting treatment with both drugs. Hepatitis Revitalization B may cause severe liver damage, liver failure, or death. Your doctor will test you for hepatitis B before you start taking Harvoni or Mavyret. If positive test for hepatitis B, you may need to take medications to treat it. Harvoni and Mavyret have not been compared to clinical studies, but both are effective in treating hepatitis C.According to, Harvoni and Mavyret both are first-choice treatment options for hepatitis C geneotypes 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 in which one medicine would be recommended about the other: CostsThe funvoni and Mavyret are both brand-name drugs. There are currently no generic forms of either of the two drugs available. Brand-named drugs usually cost more than generics. According to estimates about , Harvoni is generally much more expensive than Mavyret. The real cost you pay for any medication will depend on your insurance plan and the pharmacy you use. Note: A de Harvoni is expected to be released early in 2019. The manufacturer estimates that the cost for a drug course will be $24,000. This price is considerably lower than the price of the brand version. Harvoni vs. SovaldiHarvoni and Sovaldi are used to treat hepatitis C. Harvoni is a combined tablet containing two medications: ledipasvir and sofosbuvir. Sovaldi contains a medication: sofosbuvir. UsesHarvoni is approved by FDA to treat hepatitis C in adults with genotypes 1, 4, 5 or 6. It can also be used to treat children with these genotypes that are 12 years or older or weigh at least 77 pounds. Sovaldi is also approved to treat hepatitis C, but is 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 or older or who weigh 77 pounds or more. Sovaldi is used in combination with other medicines to treat hepatitis C. The FDA is not approved to be used by itself. Forms and administration of Harvoni and Sovaldi drugs both come as tablets that you take by mouth. Harvoni is taken once a day for 8, 12 or 24 weeks. Sovaldi is also taken once a day, 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 is not used on its own to treat hepatitis C. It is prescribed with other medications, including pegilated interferon and ribavirin (Rebetol). Sovaldi's generic form 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 medicines, which can work differently from Harvoni. Because of this, the side effects seen with Sovaldi treatment depend on the medication used. Common and severe side effects for Harvoni and Sovaldi are shown below. The side effects of Sovaldi described are seen when Sovaldi is used with other hepatitis C drugs such as ribavirin and pegilated interferon. Harvoni and SovaldiHarvoni Combined Treatment Most Common Side Effects Serious Side Effects (many single serious side effects)* and both have one of the FDA for the reactivation of hepatitis B. A box warning is the strongest warning required by the FDA. Alerts doctors and patients about drug effects that can be dangerous. Harvoni and Sovaldi Effectiveness have different uses approved by the FDA, but both are used to treat hepatitis C. Harvoni is effective against the virus when used alone or with ribavirin. Sovaldi is effective in treating hepatitis C only when used in combination with other medicines, such as ribavirin and pegilated interferon. According to, Harvoni is a first choice option to treat hepatitis C in people with genotypes 1, 4, 5 or 6. It is also a first choice option for children over 12 years of age or 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. New drugs also cause less 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. CostsHarvoni and Sovaldi are brand-name medicines. There are currently no generic forms available from either drug. According to estimates of , Harvoni usually costs a little more than Sovaldi. The real price you pay for any medication will depend on your insurance and the pharmacy you use. Note: A de Harvoni is expected to be released early in 2019. The manufacturer estimates that the cost for a drug course will be $24,000. This price is considerably lower than the price of the brand version. Harvoni vs. ZepatierHarvoni contains ledipasvir and sofosbuvir medications in a single pill. Zepatier also contains two medications in a pill: elbasvir and grazoprevir. UsesHarvoni and Zepatier are both approved by the FDA to treat hepatitis C virus in adults with genotypes 1 or 4. Harvoni is also approved for the treatment of genotypes 5 and 6 in adults, and genotypes 1, 4, 5 or 6 in children 12 years or older or who weigh at least 77 pounds. Zepatier is not approved for use in children. Harvoni is approved to treat hepatitis C virus in adults with decompensated cirrhosis or who have had a liver transplant. With these conditions, your doctor will likely prescribe ribavirin with Harvoni. Zepatier is not approved for use in people with moderate or severe liver disease, decompensated cirrhosis or after a liver transplant. Zepatier is approved by the FDA 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 is difficult to deal with certain medicines. Your doctor will perform a blood test to see if you have one of these variations. If you do, you may need to take ribavirin with Zepatier. Forms and administration of Harvoni and Zepatier drugs both come as a single tablet that is taken once a day. Each can be taken with or without food. Harvoni's treatment lasts 8, 12 or 24 weeks. Zepatier's treatment lasts 12 or 16 weeks. The length of treatment prescribed by your doctor will be based on your genotype, liver function, and history of past hepatitis C treatments. Side effects and risks Harvoni and Zepatier are similar drugs and their effects on the body are similar. Therefore, they cause many of the same side effects. Below are some examples of your side effects. Harvoni and ZepatierHarvoniZepatier Most common side effects Serious side effects (many single serious side effects)* and both have one of the FDA for the reactivation of hepatitis B. A box warning is the strongest warning required by the FDA. Alerts doctors and patients about drug effects that can be dangerous. Harvoni and Zepatier have not been compared to clinical trials, but both are effective in treating hepatitis C.According to both Harvoni and Zepatier are recommended as first-class options for treating hepatitis C in adults with genotypes 1 and 4. Harvoni is also a first choice option to treat genotypes 5 and 6, but Zepatier is not. The recommendations of the directive for Harvoni and Zepatier also differ in the following conditions: CostsHarvoni and Zepatier are brand-name drugs. There are currently no generic forms available for either of the two drugs. Brand-named drugs usually cost more than generics. According to estimates of , Harvoni usually costs much more than Zepatier. The real cost you pay for any medication will depend on your insurance plan and the pharmacy you use. Note: A de Harvoni is expected to be released early in 2019. The manufacturer estimates that the cost for a drug course will be $24,000. This price is considerably lower than the price of the brand version. You should take Harvoni according to your doctor's instructions. TimingHarvoni 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 on your system. If you experience fatigue during your treatment with Harvoni, try taking the medication at night. That could help you avoid that side effect. Taking Harvoni with foodHarvoni can be taken with or without food. If you experience nausea after taking Harvoni, you can avoid that side effect by taking the medication with food. Can you crush Harvoni? It is not known if it is safe to crush Harvoni tablets, so it is better to avoid crushing them. If you have trouble swallowing Harvoni tablets, talk to your doctor about other medicines that can work best for you. Harvoni is used to treat infection with hepatitis C virus (HV). About hepatitis CHCV is transmitted through blood or body fluids. The virus primarily attacks the liver cells and causes inflammation. This leads to symptoms such as:Inmunitory systems of some people can fight HV without treatment. However, many people need medication to clean the virus and reduce long-term effects. The long-term and severe effects of hepatitis C include cirrhosis (liver cancer) and liver cancer. How does Harvoni treat hepatitis C?Harvoni is a direct action antiviral (ADA). These types of drugs treat HCV by preventing the virus from reproducing (doing copies of itself). Viruses that can't make copies eventually die and clean out of the body. Cleaning your body's virus will decrease liver inflammation and prevent further liver scarring. How long does it take to work? Some people start to feel better within a few days or weeks of starting treatment with Harvoni. However, you still need to take Harvoni all the time your doctor prescribes. In , more than 86 percent of the 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 the treatment is finished. If there is no detectable virus in your body 12 weeks after your treatment ends, you have achieved a sustained virological response (SVR). Reaching SVR means it is considered cured of hepatitis C. There have been insufficient human studies 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 do not always predict what will happen in humans. If you are pregnant or plan to become pregnant, talk to your doctor about whether Harvoni is right for you. Note: If you are taking Harvoni with ribavirin, the treatment is not safe to use during pregnancy (see "Harvoni and ribavirin" above). It is not known if Harvoni passes to human breast milk. In animal studies, Harvoni was found in breast milk but did not cause harmful effects in the breeding. However, animal studies do not always predict what will happen in humans. If you are breastfeeding or planning to breastfeed, talk to your doctor about the possible risks and benefits of taking Harvoni while breastfeeding. Note: If you are taking Harvoni with ribavirin, you should talk to your doctor about whether you can continue breastfeeding safely (see "Harvoni and ribavirin" above). Here are answers to some frequent questions about Harvoni. Do I need to follow a special diet while I take Harvoni? No, no special diet is required while taking Harvoni. However, if you experience nausea or stomach pain as a side effect of Harvoni, it may be useful to eat smaller meals and avoid foods that are greasy, spicy or acidic. Taking Harvoni with a small snack can also decrease nausea. How long will Harvoni get rid of my hepatitis C?Harvoni will start working immediately to fight the virus. However, to get rid of hepatitis C, you will need to take Harvoni for as long as your doctor prescribes. This may be 8, 12 or 24 weeks, depending on your medical history. In , almost all people who took Harvoni achieved a sustained virological response SVR) after full treatment. SVR means that the virus was no longer detectable in your blood. When a person reaches SVR, they are considered cured of hepatitis C. What is the healing rate for Harvoni? The healing rate for Harvoni depends on certain aspects of your hepatitis C. This includes if you have cirrhosis or not, what hepatitis C treatments you have tested in the past, and what virus genotype you have. For example, in Harvoni, 96% of people who fulfilled the following description were cured of hepatitis C after 12 weeks: In the same clinical studies, between 86% and 100% of people with different medical stories were cured of hepatitis C.Can hepatitis C come back after taking Harvoni? If you take Harvoni every day as indicated by your doctor and maintain a healthy lifestyle, the virus should not return. However, it is possible to relapse (have the relapsed infection). This occurs when a medicine has cured a person of hepatitis C, but blood tests detect the virus again months to years after treatment. In , up to 6 percent of people treated with Harvoni had a relapse. Also, if you are exposed to hepatitis C again after taking any hepatitis C medications, including Harvoni, you can be re-infected with the virus. Reinfection can occur the same way the original infection was contracted. Sharing needles used to inject drugs and have sex without a condom are possible reinfection routes. Avoiding these behaviors can help prevent re-infection with hepatitis C. What is a hepatitis C genotype? There are six different varieties, or types, of hepatitis C virus that are known to infect people. These strains are called genotypes. Genotypes are identified by differences in the genetic code of viruses. The most common strain of hepatitis C in the United States is genotype 1, but other strains are also observed 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. If you take too much Harvoni, you increase the risk of serious side effects. Overdose symptoms Harvoni overdose symptoms may include: What to do in case of overdose If you think you have taken too much of this medication, call your doctor or look for guidance from the American Association of Poisoning Control Centers at 800-222-1222 or through your medication. But if your symptoms are severe, call 911 or go to the nearest emergency room right away. This drug comes with several warnings. FDA Warning: Hepatitis B Virus Reactivation This drug has a box warning. This is the most serious warning of the Food and Drug Administration (FDA). A box warning alerts doctors and patients about drug effects that can be dangerous. Other Warnings Before taking Harvoni, talk to your doctor about your health history. Harvoni may not be suitable for you if you have certain medical conditions. It is not known whether Harvoni is safe or effective in people with severe kidney disease. This includes people with severe kidney deficiency or end-stage kidney disease that require hemodialysis. However, people with severe kidney disease who took Harvoni on a were treated effectively and had no serious negative effects. If you have severe kidney disease, talk to your doctor about whether Harvoni is suitable for you. When Harvoni is dispensed from the pharmacy, the pharmacist will add a expiration date to the label in the bottle. This date is typically one year from the date the medication was dispensed. The purpose of these expiration dates is to ensure the effectiveness of the medication during this time. The Food and Drug Administration (FDA) is to avoid the use of expired medicines. How long a medicine is still 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 entered. If you have unused medications that have passed your expiration date, talk to your pharmacist about whether you might still be able to use it. The following information is provided to doctors and other health professionals. Action MechanismHarvoni contains two medicines: ledipasvir and sofosbuvir. Ledipasvir inhibits HCV NS5A protein, which is necessary for efficient phosphorylation of viral RNA. NS5A block inhibition RNA replication and assembly. Sofosbuvir is an NS5B HCV polymerase inhibitor with an active metabolite (an nucleoside analogue tryhosphate) that is incorporated into HCV RNA. The active metabolite acts as a chain terminator, stopping HCV replication. Harvoni has activity against HCV 1 genotypes, 4, 5 and 6. Pharmacokinetics and metabolismHarvoni contains two active ingredients: ledipasvir and sofosbuvir. Ledipasvir reaches the maximum concentration in about four hours and is almost completely linked to plasma proteins. Metabolism occurs through oxidation through an unknown mechanism. Average life is approximately 47 hours. Unchanged drugs and their oxidative metabolites are eliminated mainly in feces. The peak concentration of Sofosbuvir occurs in 45 minutes at an hour. Plasma protein binding represents approximately 65 percent of the circulating drug. Sofosbuvir is a medication that becomes an active metabolite (GS-461203) by hydrolysis and phosphorylation in the liver. GS-461203 is more dephosphorylated to an inactive metabolite. Up to 80% of the dose is eliminated in the urine. The average life of the parent medicine is 30 minutes, and the half life of the inactive metabolite is about 27 hours. Contraindications There are no contraindications for Harvoni's use. See the ribavirin that prescribes information for contraindications for people who receive Harvoni with ribavirin. StorageHarvoni must be stored in its original container at temperatures below 860F (300C). Disclaimer: MedicalNewsToday has done everything possible to ensure that all information is in fact correct, complete and updated. However, this article should not be used as a substitute for the knowledge and experience of a graduated health professional. You should always consult your doctor or other health care professional before taking any medication. The drug information contained in this document is subject to change and is not intended to cover all uses, addresses, precautions, warnings, drug interactions, allergic reactions or possible adverse effects. The absence of warnings or other information for a given medication does not indicate that the combination of drugs or drugs is safe, effective or appropriate for all patients or all specific uses. Last medical review on January 29, 2019Most recent newsRelated coverage
Harvoni Generic Name: ledipasvir-sofosbuvir This is a combination of ledipasvir and sofosbuvir and is used to treat chronic (last long duration) , to . Sometimes it can be used with another antiviral medication (). These drugs work by reducing the amount of viruses in your body, which helps fight the infection and can help your liver recover. infection can cause severe such as scarring (), or . It is not known if this treatment can prevent it from passing the virus to others. Do not share needles, and practice "saving" (including the use of latex) to reduce the risk of passing the virus to others. Although this helps many people with, it can cause people who also have another call to get worse. Before starting this medication, tell your doctor if you have ever had . Tell your doctor right away if you have new or worsening symptoms of , such as / you don't stop, loss of appetite, /, or yellowish /. How to Use Harvoni Read the Read about Patient Information Read about your ledipasvir/sofosbuvir and every time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this with or without food as indicated by your doctor, usually once a day. The dose is based on your medical condition and response to treatment. In children, the dose is also based on . If you are using the pellet form of this medication, gently shake the package before use. To take this medication without food, open the package and pour the pellets directly into your . Bring the pellets without chewing. You can drink water after swallowing pellets if necessary. Repeat these steps if your dose is for more than one package. If you are taking this medication with food, open the package(s) and pour pellets in a small bowl with one or more spoonfuls of non-acidic soft foods (such as pudding, potato purée, ice cream). Soft food should be at room or lower temperature. After mixing gently, take the whole mixture without chewing in 30 minutes. This medicine works best when the amount of medicine in your body stays at a constant level. Therefore, take this medication at even spacing intervals. To help you remember, take it at the same time every day. Tell your doctor if you vomit within 5 hours after taking this medication. You may need to take another dose. Continue to take ledipasvir/sofosbuvir for the full duration of the prescribed time, even if symptoms disappear after a short time. Stopping the medication too early may result in a return of the infection. Acids decrease the absorption of ledipasvir. If you are taking an antacid, take at least 4 hours before or 4 hours after this medication. Other acid medications for , , or ulcers (such as prescription or over-the-counter medications including , ) may prevent ledipasvir from working. Ask your doctor or pharmacist how to use these medications safely. Side effects See also Warning Section. The tiredness, , , , or difficulty sleeping may occur. If any of these effects persist or get worse, tell your doctor or promptly. Remember that your doctor has prescribed it because you have judged that the benefit for you is greater than the risk of side effects. Many people who use this medication have no serious side effects. A very serious drug is rare. However, get medical help immediately if you notice any symptoms of a serious , including: , /swelling (especially face / / trot), severe , . This is not a complete list of possible side effects. If you note other effects that are not listed above, please contact your doctor or pharmacist. In the United States - Call your doctor to advise you on side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor to advise you about side effects. You may report side effects to Health Canada at 1-866-234-2345. Precautions Before taking ledipasvir/sofosbuvir, tell your doctor or if you are allergic to any of the medications; or if you have any other medications. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this , tell your doctor or pharmacist your medical history, especially from: another (like ), .If you have , it may be lower with . This may increase the risk of , so your doctor can adjust your plan. Tell your doctor right away if you have as sudden, shaking, fast heartbeat, , , or tingling hands/foot. Before doing surgery, tell your doctor or about all the products you use (including prescription medications and herbal products). During , this medication should be used only when it is clearly necessary. Discuss risks and benefits with your doctor. Ledipasvir/sofosbuvir, in combination with , should not be used during pregnancy by the woman or her male partner. The combination can damage an unborn baby. Two reliable forms (such as , ) should be used when at least one sexual partner is using these medications together, and for six months after stopping treatment. If you or your partner become pregnant, or if you believe that you or your partner may be pregnant, tell your doctor immediately. It is unknown if this medicine passes to milk. Talk to your doctor before breastfeeding. Breastfeeding is not recommended if this medication is used in combination with ribavirin. Talk to your pharmacist or doctor. Interactions See also How to use the section. can change how your work or increase your risk of serious side effects. This document does not contain everything possible. Keep a list of all the products you use (including prescription and nonprescription medications and herbal products) and share it with your doctor and . Do not start, stop or change the dose of any medication without your doctor's approval. Some products that may interact with this medication include: , a certain other used to treat (). This medicine can stop the removal of other medicines from your body, which can affect how they work. Examples include flibanserina, , among others. Other medications may affect the removal of ledipasvir/sofosbuvir from your body, which may affect how this medication works. Examples include rifamycins (such as , ), San Juan herb, /, medications used to treat (such as , , phenitoin, ), among others. Do not take this medication with other products containing sofosbuvir. Overdose If someone has overdose and has severe symptoms like fainting or call 911. Otherwise, call a poison control center immediately. U.S. residents can call their local poison control center at 1-800-222-1222. Canadian residents can call a provincial poison control center. Don't share this with others. Laboratory tests (such as , and C) should be done before you start using this medication, while you are using it, and after completing the treatment. Keep all medical and laboratory appointments. If you are using this medication with , it is recommended that female patients or female couples of male patients take one before starting this medication. You should also take a test every month while using this medication and for 6 months after treatment ends to make sure that there is no pregnancy. If you forget a dose, take it as soon as you remember it, unless it is less than 6 hours until the next dose. In that case, skip the missed dose. Take your next dose at regular time. Do not double the dose to catch up. Store at room temperature away from light and moisture. Store the tablets in the original container. Keep pellets in the packages and do not open the packages until you are ready for use. Don't get in the bathroom. Keep everyone away from children and pets. Do not throw medications on the toilet or pour them into a drainage unless you are told to. Discard this product correctly when it is expired or is no longer necessary. See your local waste disposal company. Images Harvoni 90 mg-400 mg tabletHarvoni 33.75 mg-150 mg of oral pellets in the packetHarvoni 45 mg-200 mg of oral pellets in the packageHarvoni 33.75 mg-150 mg of oral pellets in the packetHarvoni 45 mg-200 mg of oral pellets in the packHarvoni 45 mg-200 mg tablet Harvoni is 90 mg-400 Harvoni oral pellets 33.75 mg-150 mg in packages This medicine is an orange, diamond, filmed, tablet printed with "GSI" and "7985". 45 mg-200 mg pellets in packages This medicine is an orange, diamond, filmed, tablet printed with "GSI" and "7985". Harvoni oral pellets 33.75 mg-150 mg in packages This medicine is an orange, diamond, filmed, tablet printed with "GSI" and "7985". 45 mg-200 mg pellets in packages This medicine is an orange, diamond, filmed, tablet printed with "GSI" and "7985". Harvoni tablet 45 mg-200 mg This medicine is an orange, diamond, filmed, tablet printed with "GSI" and "7985". Related Links Find other medicines that treat your condition No data Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from an authorized data provider and is not for distribution, except as may be authorized by applicable terms of use. USE CONDITIONS: The information in this database is intended to complement, not replace, the experience and judgment of health professionals. The information is not intended to cover all possible uses, addresses, precautions, drug interactions or adverse effects, nor should it be interpreted that the use of a particular medication is safe, appropriate or effective for you or any other person. A health care professional should be consulted before taking any medication, changing any diet or starting or interrupting any treatment course. 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