What is elbasvir/grazoprevir?
Elbasvir/grazoprevir is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of chronic (lasting a long time) hepatitis C virus (HCV) infection.
HCV is an opportunistic infection. An opportunistic infection is an infection that occurs more frequently or is more severe in people with weakened immune systems—such as those infected with HIV—than in people with healthy immune systems.
What HIV-related opportunistic infections is elbasvir/grazoprevir used for?
The Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents, prepared by the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), and the HIV Medicine Association of the Infectious Diseases Society of America (IDSA-HIVMA), and the Hepatitis C Guidance: AASLD-IDSA Recommendations for Testing, Managing, and Treating Adults Infected with Hepatitis C Virus, prepared by the American Association for the Study of Liver Diseases (AASLD), the Infectious Diseases Society of America (IDSA), and the International Antiviral Society-USA (IAS-USA), both include recommendations on the HIV-related uses of elbasvir/grazoprevir to treat chronic HCV infection.
In addition to recommendations for the medicine's use in treating chronic HCV infection, the guidelines and the guidance include recommendations on the “off-label” use of elbasvir/grazoprevir to treat acute HCV infection in HIV-infected individuals. “Off-label” use refers to use of an FDA-approved medicine in a manner different from that described on the medicine label. Good medical practice and the best interests of a patient sometimes require that a medicine be used “off-label.”
What should I tell my health care provider before taking elbasvir/grazoprevir?
Before taking elbasvir/grazoprevir, tell your health care provider:
- If you are allergic to elbasvir, grazoprevir, or any other medicines.
- About any medical conditions you have or have had, especially HIV infection and liver problems other than HCV infection.
- If you have ever taken any medicine for HCV infection.
- If you have had or are waiting for a liver transplant.
- If you take any of the following medicines: cobicistat, efavirenz, etravirine, nevirapine, or any HIV protease inhibitors.
- About anything that could affect your ability to take medicines, such as difficulty swallowing or remembering to take tablets.
- If you are pregnant or plan to become pregnant. Whether elbasvir/grazoprevir can harm an unborn baby is unknown. Talk to your health care provider about possible risks with taking elbasvir/grazoprevir when pregnant. Sometimes elbasvir/grazoprevir is taken with the HIV medicine ribavirin. Ribavirin may cause birth defects or death of an unborn baby. Pregnant women and men whose partners are pregnant should not use elbasvir/grazoprevir with ribavirin. Women should also not become pregnant for 6 months after they stop taking ribavirin or for 6 months after their male partners stop taking ribavirin.
- If you are breastfeeding or plan to breastfeed. Do not breastfeed if you are infected with HIV.
- About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Elbasvir/grazoprevir may affect the way other medicines or products work, and other medicines or products may affect how elbasvir/grazoprevir works. Ask your health care provider if there are interactions between elbasvir/grazoprevir and the other medicines you take.
Ask your health care provider about possible side effects from elbasvir/grazoprevir. Your health care provider will tell you what to do if you have side effects.
How should I take elbasvir/grazoprevir?
Take elbasvir/grazoprevir according to your health care provider’s instructions. Your health care provider will tell you how much elbasvir/grazoprevir to take and when to take it. Before you start elbasvir/grazoprevir and each time you get a refill, read any printed information that comes with your medicine.
How should elbasvir/grazoprevir be stored?
- Store elbasvir/grazoprevir at room temperature, 68°F to 77°F (20°C to 25°C).
- Do not use elbasvir/grazoprevir if the original package seal is broken.
- Throw away elbasvir/grazoprevir that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
- Keep elbasvir/grazoprevir and all medicines out of reach of children.
Where can I find more information about elbasvir/grazoprevir?
More information about elbasvir/grazoprevir is available:
- Recommendations on the HIV-related uses of elbasvir/grazoprevir, from the Guidelines for the Prevention and Treatment of Opportunistic infections in HIV-Infected Adults and Adolescents, prepared by CDC, NIH, and IDSA-HIVMA.
- Recommendations on the HIV-related uses of elbasvir/grazoprevir, from the Hepatitis C Guidance: AASLD-IDSA Recommendations for Testing, Managing, and Treating Adults Infected with Hepatitis C Virus, prepared by AASLD, IDSA, and IAS-USA.
- Elbasvir/grazoprevir-related research studies, from the AIDSinfo database of ClinicalTrials.gov study summaries.
The above Patient Version drug summary is based on the following FDA label(s): Tablet (film coated)
Last Reviewed: May 18, 2016