Ledipasvir & Sofosbuvir

Ledipasvir/sofosbuvir is a prescription medication used to treat chronic hepatitis C virus (HCV) genotype 1, 4, 5, or 6 infection. Ledipasvir/sofosbuvir is also used to treat people infected with HCV and HIV. Ledipasvir/sofosbuvir may also be used with the medication ribavirin to treat people with HCV and cirrhosis.

It comes as a single tablet that contains 2 medications: ledipasvir and sofosbuvir. Ledipasvir/sofosbuvir belongs to a group of drugs called antiviral medications. They work by decreasing the amount of hepatitis C virus (HCV) in the body.

This medication comes in tablet form and is taken once daily.

Common side effects of ledipasvir/sofosbuvir include tiredness, headache, and weakness.

Ledipasvir/sofosbuvir is a prescription medication used to treat the following:

• Chronic hepatitis C virus (HCV) genotype 1, 4, 5, or 6 infection
• Chronic HCV/HIV co-infections

Harvoni is given with ribavirin to treat: 

• HCV genotype 1 infection with advanced cirrhosis, or
• HCV genotype 1 or 4 infection with or without cirrhosis who have had a liver transplant

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Ledipasvir/sofosbuvir is a two-drug fixed-dose combination product that contains 90 mg of ledipasvir and 400 mg of sofosbuvir in a single tablet.

The recommended dosage of is one tablet taken orally once daily with or without food.

There is a risk of hepatitis B virus (HBV) becoming an active infection in those who have a current or previous infection with HBV and is treated with a certain antiviral medication (a direct-acting antiviral) to treat hepatitis C virus. Your healthcare provider will screen and monitor for HBV in those taking a direct-acting antiviral. Tell your healthcare provider if you have a history of hepatitis B infection or other liver problems before you are treated for hepatitis C. 

Contact your healthcare provider immediately if you develop weakness, fatigue, nausea, vomiting, yellow eyes or skin, loss of appetite, or light-colored stools. These may be signs and symptoms of a serious liver problem. 

Do not take ledipasvir/sofosbuvir if you:

• are allergic to ledipasvir/sofosbuvir or to any of its ingredients
• are taking medications containing sofosbuvir, including Solvadi

Common side effects of ledipasvir/sofosbuvir include the following:

• fatigue (tiredness)
• headache

This is not a complete list of ledipasvir/sofosbuvir side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Ledipasvir/sofosbuvir may affect the way other medicines work, and other medicines may affect how ledipasvir/sofosbuvir works.

You should not take ledipasvir/sofosbuvir if you also take other medicines that contain sofosbuvir (Sovaldi).

Especially tell your healthcare provider if you take any of the following medicines: 

• amiodarone (Cordarone)
• an antacid that contains aluminum or magnesium hydroxide. If you take an antacid during treatment with ledipasvir/sofosbuvir, take the antacid 4 hours before or 4 hours after you take ledipasvir/sofosbuvir. 
• carbamazepine (Carbatrol, Epitol, Equetro, Tegretol)

• digoxin (Lanoxin)
• efavirenz, emtricitabine, tenofovir disoproxil fumarate (Atripla)
• elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate (Stribild)
• medicines for indigestion, heartburn, or stomach ulcers, such as nizatidine (Axid), famotidine (Pepcid AC), cimetidine (Tagamet), ranitidine (Zantac), esomeprazole (Nexium), lansoprazole (Prevacid), omeprazole (Prilosec), rabeprazole (Aciphex), or pantoprazole (Protonix)
• oxcarbazepine (Trileptal, Oxtellar XR)
• phenytoin (Dilantin, Phenytek)
• phenobarbital (Luminal)
• rifabutin (Mycobutin)
• rifampin (Rifadin, Rifamate, Rifater, Rimactane)
• rifapentine (Priftin)
• rosuvastatin (Crestor) and atorvastatin (Monitor for statin-related adverse reactions such as myopathy (issues with the muscles that can lead to muscle weakness) and rhabdomyolysis (a rare but serious side effect in which the muscle tissue breaks down)
• simeprevir (Olysio)
• St. John’s wort (Hypericum perforatum) or a product that contains St. John’s Wort
• tipranavir (Aptivus) used in combination with ritonavir (Norvir)
• tenofovir disoproxil fumarate (Viread, Truvada) used in combination with atazanavir (Reyataz) and ritonavir (Norvir), darunavir (Prezista) and ritonavir (Norvir), or used in combination with lopinavir and ritonavir (Kaletra) 
• warfarin (International normalized ratio (INR) values may rise and fall irregularly in those taking warfarin. As a result, frequent monitoring of INR values is recommended in patients taking warfarin)

This is not a complete list of ledipasvir/sofosbuvir drug interactions. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Ledipasvir/sofosbuvir falls into category B. There are no well-done studies that have been done in humans with this medication. In animal studies, pregnant animals were given ledipasvir/sofosbuvir, and the babies did not show any medical issues related to this medication.

It is not known if ledipasvir/sofosbuvir crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using ledipasvir/sofosbuvir.