An Overview of Harvoni (Ledipasvir/Sofosbuvir)

Drug Class: Opportunistic Infections and Coinfections

What Is Ledipasvir/Sofosbuvir?

Harvoni bottle and pill

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 (HCV) Infection in adults and in children 12 years of age and older or weighing at least 77 pounds (35 kg). The medicine combines two drugs (ledipsavir and sofosbuvir) in a single pill.

HCV is an opportunistic infection of HIV. An opportunistic infection is an infection that occurs more frequently or is more severe in people with weakened immune systems -- such as those infected with HIV -- than in people with healthy immune systems. To learn more about opportunistic infections, read the AIDS_info_ What is an Opportunistic Infection? fact sheet.

The Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents, prepared by the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), and the HIV Medicine Association of the Infectious Diseases Society of America (IDSA-HIVMA), and the Hepatitis C Guidance: AASLD-IDSA Recommendations for Testing, Managing, and Treating Adults Infected with Hepatitis C Virus, prepared by the American Association for the Study of Liver Diseases (AASLD), the Infectious Diseases Society of America (IDSA), and the International Antiviral Society-USA (IAS-USA), both include recommendations on the use of ledipasvir/sofosbuvir to treat chronic HCV infection in people also infected with HIV.

In addition to recommendations for the medicine's use in treating chronic HCV infection, the guidelines and the guidance include recommendations on the off-label use of ledipasvir/sofosbuvir to treat acute HCV infection in HIV-infected individuals. Off-label use refers to use of an FDA-approved medicine in a manner different from that described on the medicine label. Good medical practice and the best interests of a patient sometimes require that a medicine be used off-label.

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 any medical conditions you have or have had, for example, diabetes or liver problems.
  • If you take a medicine called tipranavir.
  • 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. Whether ledipasvir/sofosbuvir can harm an unborn baby is unknown. Ledipasvir/sofosbuvir should be used during pregnancy only if the potential benefit justifies the potential risk to the unborn baby. 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 are infected with 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?

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?

  • 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 its original container.
  • Do not use ledipasvir/sofosbuvir if the original seal over the bottle 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?

More information about ledipasvir/sofosbuvir is available:

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