Drug information

Audio
Download files:
Ledipasvir_Sofosbuvir.mp3
Pronounce:
Ledipasvir/Sofosbuvir
Brand Name
Harvoni
Other Names
LDV / SOF
Drug Class
Antiviral (Hepatitis C Virus NS5A Inhibitor/NS5B Polymerase Inhibitor)
 

What is Harvoni?What is Harvoni?

What is Harvoni?

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

How is Harvoni 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 Harvoni to treat acute and chronic HCV in people with HIV.    

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

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

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

Before taking Harvoni, tell your health care provider:

  • If you are allergic to any of the medicines in Harvoni (ledipasvir or sofosbuvir) or any other medicines.
  • About any medical conditions you have or have had, particularly:
  • 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. Pregnancy should be avoided during combination treatment with Harvoni and ribavirin and for 6 months after completion of the treatment. Talk to your health care provider about the risks and benefits of taking Harvoni during pregnancy. The Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV may include other recommendations on the use of Harvoni during pregnancy. Please refer to these guidelines for additional information.
  • 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. Harvoni may affect the way other medicines or products work, and other medicines or products may affect how Harvoni works. Ask your health care provider if there are interactions between Harvoni and the other medicines you take.

How should I take Harvoni?How should I take Harvoni?

How should I take Harvoni?

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

What side effects can Harvoni cause?What side effects can Harvoni cause?

What side effects can Harvoni cause?

Harvoni may cause side effects that can be mild or serious. To learn about possible side effects of Harvoni, 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 Harvoni be stored?How should Harvoni be stored?

How should Harvoni be stored?

  • Store Harvoni tablets and pellets below 86°F (30°C).
  • Keep Harvoni 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 Harvoni tablets if the original seal over the container opening is broken or missing.
  • Do not use Harvoni pellets if the carton tamper-evident seal or the pellets packet seal is broken or missing.
  • Throw away Harvoni that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
  • Keep Harvoni and all medicines out of reach of children.

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

Where can I find more information about Harvoni?

 

Last Reviewed: May 9, 2025