Drugs

The information on this page is no longer maintained by AIDSinfo. To search for up-to-date information, visit the drug database.
Simeprevir

Simeprevir

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

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 infection (HCV). Simeprevir should be used together with other antiviral medicines to treat chronic HCV infection.

HCV infection is 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 those people with HIV—than in people with healthy immune systems. To learn more about OIs, read the AIDSinfo What is an Opportunistic Infection? fact sheet.

To learn how HIV and HCV are connected, read the AIDSinfo HIV and Hepatitis C fact sheet. The fact sheet includes information about how HCV is spread, symptoms of HCV, and treatment options.

How is simeprevir used in people with HIV?

How is simeprevir used in people with HIV?

The Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents and the Hepatitis C Guidance: AASLD-IDSA Recommendations for Testing, Managing, and Treating Adults Infected with Hepatitis C Virus both include recommendations on the HIV-related use of simeprevir to treat HCV infection.

Using a medicine as indicated on the medicine label is called on-label use; using the medicine in a different way is called off-label use. Off-label use, for example, can include using a drug for a different disease or medical condition. Good medical practice and the best interests of a patient sometimes require that a medicine be used off-label.

The guidelines include recommendations on the following uses of simeprevir:
  • On-label use: treatment of chronic HCV
  • Off-label use: treatment of acute HCV

This may not include all of the HIV-related uses of simeprevir recommended in the guidelines. Some recommended uses, such as uses in certain rare circumstances, may have been omitted.

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

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, including current or prior hepatitis B virus infection.
  • 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. Talk to your health care provider about possible risks with taking simeprevir when pregnant. Sometimes simeprevir is taken with the HCV medicine ribavirin. Ribavirin may cause birth defects or death of an unborn baby. Pregnant women and men whose partners are pregnant should not use simeprevir 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.
  • 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 have 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?

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?

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?

Where can I find more information about simeprevir?

More information about simeprevir is available:

Print