- Side Effects
- Drug Interactions
- Warnings & Precautions
- Things to Know
Brand Name: Harvoni
Generic Name: ledipasvir and sofosbuvir
Drug Class: HCV NS5A Inhibitors; HCV Polymerase Inhibitors
What is Harvoni? What is Harvoni used for?
Harvoni is an oral tablet containing two drugs used for the treatment of chronic infection with the hepatitis C virus (HCV), genotype 1 in adults. The components belong to a class of drugs called direct-acting antiviral agents. Similar drugs include:
- boceprevir (Victrelis),
- sofosbuvir (Sovaldi),
- simeprevir (Olysio),
- telaprevir (Incivek), and
- Viekira Pak (ombitasvir, paritaprevir, ritonavir, dasabuvir).
Harvoni contains ledipasvir and sofosbuvir. Sofosbuvir is converted to an active form in the body before it is effective. The active form of sofosbuvir directly blocks replication of the HVC by interfering with a hepatitis C virus enzyme called NS5B. Ledipasvir is an inhibitor of another hepatitis C virus enzyme called NS5A, which also is needed for viral replication. Both drugs in Harvoni interfere with enzymes needed by the hepatitis C virus to multiply and make new viruses, thus reducing the overall viral load. The efficacy of sofosbuvir has been established in subjects with hepatitis C virus genotypes 1, 2, 3, and 4.
Harvoni does not require administration with interferons or ribavirin (Rebetol). In clinical studies, 96%-99% of patients who were not previously treated for their hepatitis C virus were cured after 12 weeks of Harvoni treatment. The cure was defined as undetectable levels of hepatitis C virus in the blood when measured three months after the completion of treatment. Harvoni was approved by the FDA in October 2014.
What brand names are available for Harvoni?
Is Harvoni available as a generic drug?
Do I need a prescription for Harvoni?
What are the side effects of Harvoni ?
- There is an increased risk of low heart rate (bradycardia) when Harvoni is combined with amiodarone (Cordarone).
- Harvoni should not be combined with Sovaldi (sofosbuvir) or other drugs containing sofosbuvir.
What is the dosage for Harvoni ?
The recommended treatment dose is one tablet by mouth once daily with or without food. Duration of treatment depends on whether patients have been previously treated with other agents for their infection and the presence or absence of cirrhosis. The usual recommended duration of treatment is as follows:
- Treatment-naïve patients with or without cirrhosis: 12 weeks treatment.
- Eight weeks of treatment may be used for treatment-naïve patients without cirrhosis who have pre-treatment HCV RNA levels of less than 6 million IU/mL
- Previously treated without cirrhosis: 12 weeks of treatment
- Previously treated with cirrhosis: 24 weeks of treatment.
Which drugs or supplements interact with Harvoni ?
Acid-reducing agents which are commonly used to treat heartburn, indigestion, and GERD may decrease the effectiveness of Harvoni treatment by decreasing blood levels of ledipasvir. Examples of acid-reducing agents include antacids, histamine 2 receptor antagonists, for example, famotidine (Pepcid), and proton pump inhibitors (PPIs), for example, omeprazole (Prilosec).
Antacid and Harvoni administration should be separated by 4 hours. Doses of histamine 2 receptor antagonists equivalent to famotidine 40 mg twice daily or less and doses of proton pump inhibitors equivalent to 20 mg of omeprazole or lower may be given at the same time as Harvoni.
Co-administration of Harvoni and amiodarone is not recommended because the combination may cause serious heart-related side effects including symptomatic bradycardia.
Anti-seizure medications including carbamazepine (Tegretol), phenytoin (Dilantin), phenobarbital (Luminal), and oxcarbazepine (Trileptal) may increase the breakdown of Harvoni, leading to reduced therapeutic effectiveness.
Taking St. John's Wort or rifampin with Harvoni may also reduce the effectiveness of treatment and is not recommended.
Certain medications used to treat tuberculosis (TB) infection may decrease the effectiveness of Harvoni treatment. Patients taking rifampin, rifabutin, or rifapentine should consult with their doctor or pharmacist before starting Harvoni.
Co-administration of Harvoni with rosuvastatin (Crestor), a cholesterol-lowering medication, may significantly increase the blood concentration of rosuvastatin and increase the risk of side effects such as serious muscle injury.
Drug interactions with certain HIV antiretroviral therapies and Harvoni have also been reported. Patients receiving HIV treatment are advised to consult with their doctor or pharmacist before starting Harvoni.
PREGNANCY: Although no fetal adverse events were reported in animal studies, adequate and well-controlled studies of Harvoni treatment in pregnant women are lacking. Therefore, Harvoni should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
NURSING MOTHERS: It is not known whether Harvoni is excreted into human milk. Due to the lack of conclusive safety data, Harvoni should be used cautiously while breastfeeding.
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Is Harvoni safe to take while pregnant or breastfeeding?
If Harvoni is administered with ribavirin, the combination regimen is contraindicated in pregnant women and in men whose female partners are pregnant. Refer to the ribavirin prescribing information for more information on ribavirin-associated risks of use during pregnancy.
No adequate human data are available to establish whether or not Harvoni alone poses a risk to pregnancy outcomes.
It is not known whether ledipasvir or sofosbuvir, the components of Harvoni, or their metabolites are present in human breast milk, affect human milk production, or have effects on the breastfed infant.
The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for Harvoni and any potential adverse effects on the breastfed child from Harvoni or the underlying maternal condition.
If Harvoni is administered with ribavirin, the nursing mother’s information for ribavirin also applies to this combination regimen. Refer to the ribavirin prescribing information for more information on use during lactation.
What else should I know about Harvoni ?
Oral tablets containing 90 mg ledipasvir and 400 mg sofosbuvir.How should I keep Harvoni stored?
Harvoni should be stored in its original container and at room temperature, between 15 C and 30 C (59 F and 86 F).
Ledipasvir and sofosbuvir (Harvoni) is a combination drug prescribed to treat chronic hepatitis C infection. Side effects, drug interactions, storage, dosing, and pregnancy information should be reviewed prior to taking any medication.
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Related Disease Conditions
Cirrhosis of the liver refers to a disease in which normal liver cells are replaced by scar tissue caused by alcohol and viral hepatitis B and C. This disease leads to abnormalities in the liver's ability to handle toxins and blood flow, causing internal bleeding, kidney failure, mental confusion, coma, body fluid accumulation, and frequent infections. Symptoms include yellowing of the skin (jaundice), itching, and fatigue. The prognosis is good for some people with cirrhosis of the liver, and the survival can be up to 12 years; however the life expectancy is about 6 months to 2 years for people with severe cirrhosis with major complications.
Liver (Anatomy and Function)
The liver is the largest gland and organ in the body. There are a variety of liver diseases caused by liver inflammation, scarring of the liver, infection of the liver, gallstones, cancer, toxins, genetic diseases, and blood flow problems. Symptoms of liver disease generally do not occur until the liver disease is advanced. Some symptoms of liver disease include jaundice, nausea and vomiting, easy bruising, bleeding excessively, fatigue, weakness, weight loss, shortness of breath, leg swelling, impotence, and confusion. Treatment of diseases of the liver depends on the cause.
Jaundice in Adults (Hyperbilirubinemia)
Jaundice or hyperbilirubinemia in adults is caused by an underlying disease or condition. Learn about when to worry about jaundice in adults, symptoms, treatment, causes, diagnosis, and prevention.
Hepatitis (Viral Hepatitis A, B, C, D, E, G)
Hepatitis is most often viral, due to infection with one of the hepatitis viruses (A, B, C, D, E, F (not confirmed), and G) or another virus (such as those that cause infectious mononucleosis, cytomegalovirus disease). The main nonviral causes of hepatitis are alcohol and drugs. Many patients infected with hepatitis A, B, and C have few or no symptoms of illness. For those who do develop symptoms of viral hepatitis, the most common are flu-like symptoms including: loss of appetite, nausea, vomiting, fever, weakness, tiredness, and aching in the abdomen. Treatment of viral hepatitis is dependent on the type of hepatitis.
Hepatitis C (HCV, Hep C)
Hepatitis C is an inflammation of the liver due to the hepatitis C virus (HCV), which is usually spread by blood transfusion, hemodialysis, and needle sticks, especially with intravenous drug abuse. Symptoms of chronic hepatitis include fatigue, fever, muscle aches, loss of appetite, and fever. Chronic hepatitis C may be cured in most individuals with drugs that target specific genomes of hepatitis C.
Is Hepatitis Contagious?
Hepatitis means "inflammation of the liver," and there are several different types of such as A, B, C, D, and E. Some types of hepatitis are contagious and some types are not. Hepatitis symptoms vary upon the type of disease; however, the following symptoms may develop in someone with hepatitis: fatigue, nausea and vomiting, abdominal pain and discomfort, jaundice (yellowing of the skin and whites of the eyes), and loss of appetite. Treatment for hepatitis depends upon the cause. Some types of hepatitis have a vaccine to prevent spread of disease such as hepatitis A and B.
Is Hepatitis C Contagious?
Hepatitis C or hep C causes acute and chronic liver disease. Hep C is a form of liver disease with symptoms like fatigue, jaundice, nausea and vomiting, anorexia, and abdominal discomfort. Hepatitis C is a contagious viral infection caused by people sharing drug needles, surgical instruments that have not been properly sanitized, and organ transplantation.
Hepatitis C Cure (Symptoms, Transmission, Treatments, and Cost)
Hepatitis is inflammation of the liver. There are a variety of toxins, diseases, illicit drugs, medications, bacterial and viral infections, and heavy alcohol use can case inflammation of the liver. Hepatitis C viral infection (HCV) is one type of hepatitis. According to the CDC, in 2014 there were an estimated 30,500 cases of acute hepatitis C infections in the US. An estimated 2.7-3.9 million people in the US have chronic hepatitis C. The virus is spread from person-to-person via blood-to-blood contact. Symptoms of HCV infection include joint pain, jaundice, dark urine, nausea, fatigue, fever, loss of appetites, clay colored stool. Hepatitis C can be cured with medications in most people. There is no vaccine against the hepatitis C virus.
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