Drug information

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Sofosbuvir
Other Names
SOF, Sovaldi
Drug Class
Antiviral (Hepatitis C Virus NS5B Polymerase Inhibitor)
 

What is sofosbuvir?What is sofosbuvir?

What is sofosbuvir?

Sofosbuvir 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 3 years of age and older who meet specific 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 how HCV is spread, symptoms of HCV, and treatment options.

How is sofosbuvir used in people with HIV?How is sofosbuvir used in people with HIV?

How is sofosbuvir used in people with HIV?

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

The recommended uses may not always be consistent with FDA-approved uses of sofosbuvir. See the Adult and Pediatric Opportunistic Infection Guidelines and the AASLD-IDSA HCV Guidelines for complete information on recommended uses of sofosbuvir in adults and children with HIV. Sofosbuvir may have other recommended uses not listed above. 

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

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

Before taking sofosbuvir, tell your health care provider:

  • If you are allergic to sofosbuvir or any other medicines.
  • About any medical conditions you have or have had, especially:
  • 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. Sofosbuvir, in combination with ribavirin or with peginterferon alfa and ribavirin, should not be used during pregnancy. Two forms of effective birth control should be used to avoid pregnancy. You should not become pregnant for 6 months after either you or your partner stop taking these medicines. Talk to your health care provider about possible risks with taking sofosbuvir during pregnancy.
  • If you are breastfeeding or plan to breastfeed. For mothers with HIV in the United States, the Guideline recommends speaking with your health care provider to discuss options for feeding your baby. Mothers with suppressed viral load have a less than 1% chance of transmitting HIV to their baby via their own milk. Although most medicines are safe to use while breastfeeding, some medicines should be avoided. Always let your health care provider know about all the medicines and supplements you are using before you start breastfeeding.
  • About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Sofosbuvir may affect the way other medicines or products work, and other medicines or products may affect how sofosbuvir works. Ask your health care provider if there are interactions between sofosbuvir and the other medicines you take.

How should I take sofosbuvir?How should I take sofosbuvir?

How should I take sofosbuvir?

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

What side effects can sofosbuvir cause?What side effects can sofosbuvir cause?

What side effects can sofosbuvir cause?

Sofosbuvir may cause side effects that can be mild or serious. To learn about possible side effects of sofosbuvir, see the FDA drug label or talk to your health care provider or pharmacist. Tell your health care professional if you have any side effect that bothers you or that does not go away. Your health care professional may be able to tell you about ways to prevent or reduce some side effects.

You may report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or online.

How should sofosbuvir be stored?How should sofosbuvir be stored?

How should sofosbuvir be stored?

  • Store sofosbuvir tablets or pellets below 86°F (30°C).
  • Keep sofosbuvir in the container that it came in and keep the container tightly closed. If the container has a small packet of drying agent (called a desiccant), do not remove it. The desiccant protects the medicine from moisture.
  • Do not use sofosbuvir if the original seal over the container opening is broken or missing.
  • Throw away sofosbuvir that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
  • Keep sofosbuvir and all medicines out of reach of children.

Where can I find more information about sofosbuvir?Where can I find more information about sofosbuvir?

Where can I find more information about sofosbuvir?

 

 

Last Reviewed: April 30, 2025