Elbasvir & Grazoprevir

Elbasvir and grazoprevir together form a prescription medication used with or without ribavirin to treat chronic (long-lasting) hepatitis C virus (HCV) genotypes 1 or 4 infection in adults. Elbasvir and grazoprevir belong to a group of drugs called antiviral medications. These work by targeting certain proteins in the HCV to keep it from reproducing in the body.

This medication comes in tablet form and is typically taken once a day, with or without food.

Common side effects of elbasvir and grazoprevir include headache, nausea, and diarrhea.

Elbasvir and grazoprevir can also cause drowsiness. Do not drive or operate heavy machinery until you know how this medication affects you.

Elbasvir and grazoprevir together form a prescription medication used with or without ribavirin to treat chronic (long-lasting) hepatitis C virus (HCV) genotypes 1 or 4 infection in adults.

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

Elbasvir & Grazoprevir may be found in some form under the following brand names:

• Zepatier

Serious side effects have been reported with elbasvir and grazoprevir. See the "Elbasvir and Grazoprevir Precautions" section.

Common side effects of elbasvir and grazoprevir when used without ribavirin include the following:

• drowsiness
• headache
• nausea
• trouble sleeping
• diarrhea

Common side effects of elbasvir and grazoprevir when used with ribavirin include the following:

• low red blood cell counts (anemia)
• headache
• drowsiness
• shortness of breath
• rash or itching
• feeling irritable
• stomach pain
• depression
• joint pain

This is not a complete list of elbasvir and grazoprevir 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 doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Anticonvulsants
  • phenytoin (Dilantin)
  • carbamazepine (Tegretol)
• Antimycobacterials
  • rifampin (Rifadin)
• Herbal Products
  • St. John's wort (Hypericum perforatum)
• HIV Medications
  • efavirenz (Sustiva, Stocrin)
  • atazanavir (Reyataz)
  • darunavir (Prezista)
  • lopinavir/ritonavir (Kaletra)
  • saquinavir (Invirase, Fortovase)
  • tipranavir (Aptivus)
• Immunosuppressants
  • cyclosporine (Neoral, Sandimmune)
• Statins used to lower cholesterol such as atorvastatin and rosuvastatin (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)
• 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 elbasvir and grazoprevir drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with elbasvir and grazoprevir including the following:

• ALT Elevations (a rise in liver enzymes in the blood which indicates liver damage). Tell your healthcare provider right away if you have some or all of the following symptoms of ALT Elevations
  • fatigue
  • weakness
  • lack of appetite
  • nausea and vomiting
  • jaundice (yellow skin or whites of the eyes)
  • discolored feces
• Risks Associated with Ribavirin Combination Treatment
  • see Drug Precautions for ribavirin

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 elbasvir and grazoprevir if you:

• are allergic to elbasvir and grazoprevir or to any of its ingredients
• have moderate or severe hepatic impairment (Child-Pugh B or C)
• are taking certain medications such as OATP1B1/3 inhibitors, strong CYP3A inducers, or efavirenz (tell your doctor about all the medicines you take)

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of elbasvir and grazoprevir, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking elbasvir and grazoprevir, tell your doctor about all of your medical conditions. Especially tell your doctor if you have liver problems other than hepatitis C.

• are allergic to elbasvir and grazoprevir or to any of its ingredients
• have ever taken any medicine for hepatitis C
• if you have a history of hepatitis B infection
• have HIV
• have had or are waiting for a liver transplant
• have any other medical conditions
• are pregnant or trying to get pregnant. elbasvir and grazoprevir have not been studied in pregnant women. We do not know if elbasvir and grazoprevir will harm your baby while you are pregnant.
• are breastfeeding or plan to breastfeed. We do not know if elbasvir and grazoprevir gets in your breast milk and gets passed to your baby. Talk to your healthcare provider about the best way to feed your baby during treatment with elbasvir and grazoprevir.

Males and females who take elbasvir and grazoprevir and ribavirin should also read the ribavirin drug precautions for important pregnancy, contraception, and infertility information.

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

There are no well-done studies that have been done in pregnant women with elbasvir and grazoprevir. It is not known if elbasvir and grazoprevir will harm your baby while you are pregnant.

Males and females who take this medication and ribavirin should also read the ribavirin medication guide for important pregnancy, contraception, and infertility information.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if elbasvir and grazoprevir cross into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with the use of this medication, talk to your healthcare provider about the best way to feed your baby during treatment with elbasvir and grazoprevir. 

Take elbasvir and grazoprevir exactly as prescribed.

Elbasvir and grazoprevir come in a blister package of individually-packaged tablets. Keep the tablets in the blister package until you are ready to take your dose.

Take elbasvir and grazoprevir tablets once a day, with or without food.

Do not stop taking this medication without first talking with your healthcare provider.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dosage is one tablet (50 mg elbasvir and 100 mg grazoprevir) once a day.

If you take too much elbasvir and grazoprevir, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store elbasvir and grazoprevir in the original blister package until use to protect from moisture.
• Store elbasvir and grazoprevir at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (between 59°F to 86°F).
• Keep elbasvir and grazoprevir and all medicines out of the reach of children

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.