Drug information
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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?
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 Harvoni to treat acute and chronic HCV infection in people with HIV.
The recommended uses may not always be consistent with FDA-approved uses of Harvoni. See 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?
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:
- Kidney problems, including if you are on dialysis
- Liver problems, including hepatitis B virus infection (HBV) and liver transplant
- 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 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. 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?
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.
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 if the original seal over the container opening 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?
- Recommendations on the HIV-related use of Harvoni, from the Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV.
- Recommendations on the HIV-related uses of Harvoni, 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 Harvoni.
- The American Hospital Formulary Service (AHFS) Patient Medication Information for ledipasvir and sofosbuvir available from MedlinePlus.
- Harvoni-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.)
Last Reviewed: May 4, 2023