Drug Database: Elbasvir / Grazoprevir

What is Zepatier?

Zepatier is an antiviral prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of chronic hepatitis C virus infection (HCV) in adults and children 12 years of age and older or weighing at least 66 lb (30 kg) and who meet certain requirements, as determined by a health care provider.

HCV can be an opportunistic infection (OI) of HIV. An OI is an infection that occurs more frequently or is more severe in people with weakened immune systems—such as people with HIV—than in people with healthy immune systems. To learn more about OIs, read the HIVinfo What is an Opportunistic Infection? fact sheet.

To learn how HIV and HCV are connected, read the HIVinfo HIV and Hepatitis C fact sheet. The fact sheet includes information about HCV transmission, prevention, and treatment.

How is Zepatier used in people with HIV?

The Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV reference the AASLD-IDSA HCV Guidance: Recommendations for Testing, Managing, and Treating Hepatitis C, which includes recommendations on the use of Zepatier to treat acute and chronic HCV in people with HIV.

The recommended uses may not always be consistent with FDA-approved uses of Zepatier. See the AASLD-IDSA HCV Guidelines for complete information on recommended uses of Zepatier in people with HIV. Zepatier may have other recommended uses not listed above.

What should I tell my health care provider before taking Zepatier?

Before taking Zepatier, tell your health care provider:

• If you are allergic to any of the medicines in Zepatier (elbasvir or grazoprevir) or any other medicines.
• About any medical conditions you have or have had, especially:
  • Liver problems, including hepatitis B virus infection (HBV)
  • Liver transplant
• If you have ever taken any medicine for HCV infection. 
• About anything that could affect your ability to take medicines, such as difficulty swallowing or remembering to take pills.
• If you are pregnant or plan to become pregnant. Pregnancy should be avoided during combination treatment with Zepatier and ribavirin and for 6 months after completion of the treatment. Talk to your health care provider about the risks and benefits of taking Zepatier during pregnancy. The Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV may include other recommendations on the use of Zepatier during pregnancy. Please refer to these guidelines for additional information.
• If you are breast/chestfeeding or plan to breast/chestfeed. For people with HIV in the United States, the Guideline recommends speaking with your health care provider to discuss options for feeding your baby. People with suppressed viral load have a less than 1% chance of transmitting HIV to their baby via their own milk.
• About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products (including St. John's wort) you are taking or plan to take. Zepatier may affect the way other medicines or products work, and other medicines or products may affect how Zepatier works. Ask your health care provider if there are interactions between Zepatier and the other medicines you take.

Ask your health care provider about possible side effects from Zepatier. Your health care provider will tell you what to do if you have side effects.

How should I take Zepatier?

Take Zepatier according to your health care provider’s instructions. Your health care provider will tell you how much Zepatier to take and when to take it. Before you start Zepatier and each time you get a refill, read any printed information that comes with your medicine.

How should Zepatier be stored?

• Store Zepatier at room temperature, 68°F to 77°F (20°C to 25°C).
• Keep Zepatier in the original blister package that it came in until you are ready to take it. The blister package is designed to protect the tablets from moisture.
• Do not use Zepatier if the original seal over the blister package is broken or missing.
• Throw away Zepatier that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
• Keep Zepatier and all medicines out of reach of children.

Where can I find more information about Zepatier?

• Recommendations on the HIV-related uses of Zepatier, from the Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV. 
• Recommendations on the HIV-related uses of Zepatier, from the HCV Guidance: Recommendations for Testing, Managing, and Treating Hepatitis C.
• This Patient Version drug summary is based on the following FDA label(s): Tablet (film coated). The Patient Package Insert includes information for people taking Zepatier.
• The American Hospital Formulary Service (AHFS) Patient Medication Information for elbasvir and grazoprevir available from MedlinePlus.
• Zepatier-related research studies, from ClinicalTrials.gov. (The ClinicalTrials.gov search can be modified so that you can get results that better match your interests.)