Brand Name: Epclusa
Other Names: sofosbuvir/velpatasvir, SOF/VLP
Drug Class: Opportunistic Infections and Coinfections
What Is Sofosbuvir/Velpatasvir?
Sofosbuvir/velpatasvir 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.
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 living 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. To learn how HIV and HCV are connected, read the AIDS_info_ HIV and Hepatitis C fact sheet.
The Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents (Adult OI Guidelines), 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), refer readers to the Hepatitis C Guidance: AASLD-IDSA Recommendations for Testing, Managing, and Treating Adults Infected with Hepatitis C Virus for recommendations on the treatment of HCV in people with HIV, including recommendations on the use of sofosbuvir/velpatasvir. The AASLD-IDSA Hepatitis C Guidance is 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).
The uses of sofosbuvir/velpatasvir recommended in the AASLD-IDSA Hepatitis C Guidance includes both on-label and off-label uses of the drug. Using a medicine as indicated on the medicine label is called on-label use; using the medicine in a different way is call 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.
How Is Sofosbuvir/Velpatasvir Used in People With HIV?
The AASLD-IDSA Hepatitis C Guidance includes recommendations on the following uses of sofosbuvir/velpatasvir to treat HCV infection in people with HIV:
- To treat chronic HCV infection
- To treat acute HCV infection
Please refer to the Adult OI Guidelines and the AASLD-IDSA Hepatitis C Guidance for more information on the treatment of HCV infection in people with HIV.
What Should I Tell My Health Care Provider Before Taking Sofosbuvir/Velpatasvir?
Before taking sofosbuvir/velpatasvir, tell your health care provider:
- If you are allergic to sofosbuvir/velpatasvir or any other medicines.
- About any medical conditions you have or have had, especially HIV infection and hepatitis B virus infection and any other liver problems in addition to HCV infection.
- If you have severe kidney problems or you are on dialysis.
- 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 sofosbuvir/velpatasvir can harm an unborn baby is unknown. Talk to your health care provider about possible risks with taking sofosbuvir/velpatasvir when pregnant. Sometimes sofosbuvir/velpatasvir is taken with the medicine ribavirin. Because ribavirin may cause birth defects or death of an unborn baby, sofosbuvir/velpatasvir with ribavirin should not be used by pregnant women or by men whose partners are pregnant. Women should also not become pregnant for 6 months after they (or their male partners) stop taking ribavirin (with or without sofosbuvir/velpatasvir).
- 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. Sofosbuvir/velpatasvir may affect the way other medicines or products work, and other medicines or products may affect how sofosbuvir/velpatasvir works. Ask your health care provider if there are interactions between sofosbuvir/velpatasvir and the other medicines you take.
Ask your health care provider about possible side effects from sofosbuvir/velpatasvir. Your health care provider will tell you what to do if you have side effects.
How Should I Take Sofosbuvir/Velpatasvir?
Take sofosbuvir/velpatasvir according to your health care provider's instructions. Your health care provider will tell you how much sofosbuvir/velpatasvir to take and when to take it. Before you start sofosbuvir/velpatasvir and each time you get a refill, read any printed information that comes with your medicine.
How Should Sofosbuvir/Velpatasvir Be Stored?
- Store sofosbuvir/velpatasvir at room temperature, below 86°F (30°C).
- Keep sofosbuvir/velpatasvir in its original container.
- Do not use sofosbuvir/velpatasvir if the original seal over the container opening is broken or missing.
- Throw away sofosbuvir/velpatasvir that is no longer needed or expired (out of date).
- Follow FDA guidelines on how to safely dispose of unused medicine.
- Keep sofosbuvir/velpatasvir and all medicines out of reach of children.
Where Can I Find More Information About Sofosbuvir/Velpatasvir?
More information about sofosbuvir/velpatasvir is available:
- Recommendations on the HIV-related use(s) of sofosbuvir/velpatasvir, from the Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents, prepared by CDC, NIH, and IDSA-HIVMA
- Recommendations on the HIV-related uses of sofosbuvir/velpatasvir, from the Hepatitis C Guidance: AASLD-IDSA Recommendations for Testing, Managing, and Treating Adults Infected with Hepatitis C Virus, prepared by AASLD, IDSA, and IAS-USA.
- Sofosbuvir/velpatasvir-related research studies, from the AIDS_info_ database of ClinicalTrials.gov study summaries
The above Patient Version drug summary is based on the following FDA label(s): Tablet (film-coated).
[Note from TheBody.com: This article was originally published by AIDSinfo on Aug. 24, 2017. We have cross-posted it with their permission.]