An Overview of Harvoni (Ledipasvir/Sofosbuvir)
May 3, 2017
Drug Class: Opportunistic Infections and Coinfections
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 (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 AIDSinfo 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:
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?
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).
This article was provided by AIDSinfo. Visit the AIDSinfo website to find out more about their activities and publications.
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