Drugs

Ledipasvir/Sofosbuvir

Ledipasvir/Sofosbuvir

Other Names: Harvoni Drug Class: Opportunistic Infections and Coinfections
What is ledipasvir/sofosbuvir?

What is ledipasvir/sofosbuvir?

Ledipasvir/sofosbuvir is a 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) in adults and in children 12 years of age and older or weighing at least 77 lb (35 kg) and who meet specific requirements, as determined by a health care provider. The medicine combines two drugs (ledipsavir and sofosbuvir) in a single tablet.

HCV 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 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 ledipasvir/sofosbuvir used in people with HIV?

How is ledipasvir/sofosbuvir 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 use of ledipasvir/sofosbuvir in people with HIV.

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 and the guidance include recommendations on the following uses of ledipasvir/sofosbuvir:

On-label use:

  • Treat chronic HCV
Off-label use:
  • Treat acute HCV
The above list may not include all of the HIV-related uses of ledipasvir/sofosbuvir recommended in the guidelines and the guidance. Some recommended uses, such as uses in certain rare circumstances, may have been omitted.

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

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

Before taking ledipasvir/sofosbuvir, tell your health care provider:

  • If you are allergic to ledipasvir/sofosbuvir or any other medicines.
  • About anything that could affect your ability to take medicines, such as difficulty swallowing or remembering to take tablets.
  • About any medical conditions you have or have had, for example, liver or kidney problems. 
  • If you are pregnant or plan to become pregnant. Whether ledipasvir/sofosbuvir can harm an unborn baby is unknown. Pregnancy should be avoided during combination treatment with ledipasvir/sofosbuvir and ribavirin and for 6 months after completion of the treatment. Talk to your health care provider about possible risks with taking ledipasvir/sofosbuvir when pregnant.
  • 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. Ledipasvir/sofosbuvir may affect the way other medicines or products work, and other medicines or products may affect how ledipasvir/sofosbuvir works. Ask your health care provider if there are interactions between ledipasvir/sofosbuvir and the other medicines you take.
Ask your health care provider about possible side effects from ledipasvir/sofosbuvir. Your health care provider will tell you what to do if you have side effects.

How should I take ledipasvir/sofosbuvir?

How should I take ledipasvir/sofosbuvir?

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

How should ledipasvir/sofosbuvir be stored?

How should ledipasvir/sofosbuvir be stored?

  • Store ledipasvir/sofosbuvir at room temperature, 68°F to 77°F (20°C to 25°C), below 86°F (30°C).
  • Keep ledipasvir/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 ledipasvir/sofosbuvir if the original seal over the container opening is broken or missing.
  • Throw away ledipasvir/sofosbuvir that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
  • Keep ledipasvir/sofosbuvir and all medicines out of reach of children.

Where can I find more information about ledipasvir/sofosbuvir?

Where can I find more information about ledipasvir/sofosbuvir?

More information about ledipasvir/sofosbuvir is available:

The above Patient Version drug summary is based on the following FDA label(s): Tablet (film coated).

Last Reviewed: April 10, 2019