Drug Database: Sofosbuvir / Velpatasvir / Voxilaprevir

What is Vosevi?

Vosevi 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 who meet certain 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 Vosevi 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 Vosevi to treat HCV infection in people with HIV.

The recommended uses may not always be consistent with FDA-approved uses of Vosevi. See the AASLD-IDSA HCV Guidelines for complete information on recommended uses of Vosevi in adults with HIV. Vosevi may have other recommended uses not listed above.

What should I tell my health care provider before taking Vosevi?

Before taking Vosevi, tell your health care provider:

• If you are allergic to any of the medicines in Vosevi (sofosbuvir, velpatasvir, and voxilaprevir) or any other medicines.
• About any medical conditions you have or have had, especially:
  • Liver problems, including hepatitis B virus infection (HBV) 
  • Kidney problems, including if 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. Talk to your health care provider about the risks and benefits of taking Vosevi 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 Vosevi 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 (including St. John's wort) you are taking or plan to take. Vosevi may affect the way other medicines or products work, and other medicines or products may affect how Vosevi works. Ask your health care provider if there are interactions between Vosevi and the other medicines you take.

Ask your health care provider about possible side effects from Vosevi. Your health care provider will tell you what to do if you have side effects.

How should I take Vosevi?

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

How should Vosevi be stored?

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• Throw away Vosevi that is no longer needed or expired (out of date).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

Where can I find more information about Vosevi?

• Recommendations on the HIV-related uses of Vosevi, from the Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV.
• Recommendations on the HIV-related uses of Vosevi, 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. The Patient Package Insert includes information for people taking Vosevi.
• The American Hospital Formulary Service (AHFS) Patient Medication Information for Vosevi available from MedlinePlus.
• Vosevi-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.)