Drug Database: Sofosbuvir

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 infection 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 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 infection in people with HIV.  

The recommended uses may not always be consistent with FDA-approved uses of sofosbuvir. See the guidelines for complete information on recommended uses of sofosbuvir in adults and children with HIV. Some recommended uses, such as uses in certain rare circumstances, may have been omitted 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.
• If you have ever had hepatitis B virus infection.
• If you have had a liver transplant.
• About any medical conditions you have or have had, for example, kidney or liver problems.
• 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 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 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.

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

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.

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

How should sofosbuvir be stored?

• Store sofosbuvir at room temperature, 68°F to 77°F (20°C to 25°C), and always 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?

• Recommendations on the HIV-related use of sofosbuvir, from the Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV.
• Recommendations on the HIV-related uses of sofosbuvir, 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), pellet. The Patient Package Insert and Instructions For Use include information for people taking sofosbuvir.
• The American Hospital Formulary Service (AHFS) Patient Medication Information for sofosbuvir available from MedlinePlus.
• Sofosbuvir-related research studies, from ClinicalTrials.gov. (The ClinicalTrials.gov search can be modified so that you can get results that better match your interests. To learn more about the ClinicalTrials.gov search features, please see How to Search.)