Sofosbuvir, velpatasvir, and voxilaprevir (Vosevi) is a combination antiviral medicine that is used to treat chronic hepatitis C in adults.

Vosevi treats specific genotypes of hepatitis C, and only in certain people. Use only the medications prescribed for you. Do not share your medicine with other people.

Vosevi is sometimes used in people who also have HIV. Vosevi is not a treatment for HIV or AIDS.

Vosevi may also be used for purposes not listed in this medication guide.

If you have ever had hepatitis B, sofosbuvir, velpatasvir, and voxilaprevir can cause the condition to come back or get worse. You will need frequent blood tests to check your liver function.

Sofosbuvir, velpatasvir, and voxilaprevir is sometimes used in combination with other medication. Read the medication guide or patient instructions provided with each medication in your combination therapy.

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using sofosbuvir, velpatasvir, and voxilaprevir.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Vosevi is usually taken once per day for 12 weeks.

Take this medicine with food, at the same time each day.

You will need frequent blood tests to check your liver function.

If you've ever had hepatitis B, using Vosevi can cause this virus to become active or get worse. You may need frequent liver function tests while using this medicine and for several months after you stop.

You should not stop using Vosevi suddenly. Stopping suddenly could make your hepatitis C harder to treat with antiviral medicine.

Use all medications as directed and read all medication guides you receive. Do not change your dose or dosing schedule without your doctor's advice. Every person with chronic hepatitis C should remain under the care of a doctor.

Store this medicine in the original container at room temperature away from moisture and heat.

Usual Adult Dose for Chronic Hepatitis C:

1 tablet orally once a day for 12 weeks

Comments:
-This drug showed no additional benefit over sofosbuvir-velpatasvir in patients with genotype 1b, 2, 4, 5, or 6 infection previously treated with sofosbuvir without a nonstructural protein 5A (NS5A) inhibitor.

Uses: For the treatment of patients with chronic HCV infection without cirrhosis or with compensated cirrhosis (Child-Pugh A) who have:
-Genotype 1, 2, 3, 4, 5, or 6 infection and were previously treated with an NS5A inhibitor-containing HCV regimen; in clinical trials, prior NS5A inhibitor experience included daclatasvir, elbasvir, ledipasvir, ombitasvir, or velpatasvir
-Genotype 1a or 3 infection and were previously treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor; in clinical trials, prior treatment experience included sofosbuvir with or without any of the following: peginterferon alfa/ribavirin, ribavirin, HCV NS3/4A protease inhibitor (boceprevir, simeprevir, or telaprevir)

You should not use this medicine if you are allergic to sofosbuvir, velpatasvir, or voxilaprevir.

Tell your doctor if you have ever had:

• hepatitis B;

• liver problems other than hepatitis C;

• kidney disease (or if you are on dialysis); or

• if you use a blood thinner (warfarin, Coumadin, Jantoven) and you have routine "INR" or prothrombin time tests.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

If you also take an antacid, do not take it for at least 4 hours after you have taken your dose of Vosevi (with food).

Using sofosbuvir, velpatasvir, and voxilaprevir will not prevent your disease from spreading. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HCV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

In rare cases, Vosevi may cause serious liver injury. Call your doctor right away if you have symptoms such:

• right-sided upper stomach pain;

• nausea, vomiting, loss of appetite;

• confusion, tiredness, feeling light-headed;

• easy bruising or bleeding, vomiting blood;

• diarrhea, black or bloody stools;

• dark urine; or

• yellowing of your skin or eyes.

If you also take a heart rhythm medicine called amiodarone: Taking amiodarone with Vosevi can cause dangerous side effects on your heart. Get medical help right away if you take these medicines and you have:

• very slow heartbeats, chest pain, shortness of breath;

• confusion, memory problems; or

• weakness, extreme tiredness, light-headed feeling (like you might pass out).

Common side effects of sofosbuvir, velpatasvir, and voxilaprevir may include:

• headache;

• feeling tired; or

• nausea, diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can affect sofosbuvir, velpatasvir, and voxilaprevir. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.