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AIDSinfo Drug Database

AIDSinfo Drug Database

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Simeprevir  Audio icon

Brand Name: Olysio
Other Names: SMV, simeprevir sodium
Drug Class: Opportunistic Infections and Coinfections

Chemical Image:
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Molecular Weight: 749.9493

What is simeprevir?

Simeprevir is an antiviral 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. Simeprevir should be used together with other antiviral medicines to treat chronic HCV infection

HCV infection 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. 

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 use of simeprevir to treat chronic HCV infection in people also infected with HIV.

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 simeprevir to treat acute HCV infection. “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 simeprevir?

Before taking simeprevir, tell your health care provider:

  • If you are allergic to simeprevir or any other medicines.
  • About any medical conditions you have or have had, for example, diabetes or liver problems.
  • 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 pills.
  • If you are pregnant or plan to become pregnant. Whether simeprevir can harm an unborn baby is unknown. Simeprevir should be used during pregnancy only if the potential benefit justifies the potential risk. Talk to your health care provider about possible risks with taking simeprevir when pregnant.
  • About birth control methods that may be used during treatment with simeprevir. Women of childbearing potential must use an effective form of birth control during treatment with simeprevir.
  • 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. Simeprevir may affect the way other medicines or products work, and other medicines or products may affect how simeprevir works. Ask your health care provider if there are interactions between simeprevir and the other medicines you take.
Ask your health care provider about possible side effects from simeprevir. Your health care provider will tell you what to do if you have side effects.

How should I take simeprevir?

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

How should simeprevir be stored?

  • Store simeprevir in the original bottle to protect the simeprevir capsules from light.
  • Store simeprevir at room temperature, 68°F to 77°F (20°C to 25°C), below 30°C (86°F).
  • Do not use simeprevir if the original seal over the bottle opening is broken or missing.
  • Throw away simeprevir that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
  • Keep simeprevir and all medicines out of reach of children.

Where can I find more information about simeprevir?

More information about simeprevir is available:

The above Patient Version drug summary is based on the following FDA label(s): Capsule.

Last Reviewed: May 19, 2016

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