Sofosbuvir, velpatasvir, and voxilaprevir

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

Vosevi is effective for certain genotypes of hepatitis C and only for specific individuals. Use only the medications that your doctor has prescribed. Do not share your medicine with others.

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

Vosevi may also be used for reasons not mentioned in this medication guide.

Your doctor will do blood tests to ensure you do not have conditions that would make it unsafe for you to use sofosbuvir, velpatasvir, and voxilaprevir.

Follow all instructions 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 regular blood tests to check your liver function.

If you've ever had hepatitis B, using Vosevi can cause this virus to become active or worsen. You may need regular 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 it harder to treat your hepatitis C 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 continue to see a doctor.

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

If you have ever had hepatitis B, sofosbuvir, velpatasvir, and voxilaprevir can cause the condition to return or worsen. You will need regular blood tests to monitor your liver function.

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

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.

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

In rare cases, Vosevi may cause serious liver damage. Contact your doctor immediately if you experience symptoms like:

• pain in the upper right side of your stomach;
• 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: Using amiodarone with Vosevi can lead to serious heart-related side effects. Seek medical help immediately if you take these medicines and have:

• very slow heartbeats, chest pain, shortness of breath;
• confusion, memory issues; or
• weakness, extreme tiredness, feeling light-headed (like you might faint).

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 happen. Contact your doctor for medical advice regarding side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Usual Adult Dose for Chronic Hepatitis C:

1 tablet orally once a day for 12 weeksComments:-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)

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

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

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

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

Using sofosbuvir, velpatasvir, and voxilaprevir will not stop your disease from spreading. 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.

Sometimes, it is not safe to use certain medications together. Some drugs can change the 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. Inform your doctor about all your current medicines and any medicine you start or stop using.