Vosevi

Vosevi is a prescription drug used to treat chronic (long-lasting) hepatitis C virus in patients without cirrhosis (liver disease) or who have cirrhosis with no symptoms. Vosevi is a single product containing 3 medications: sofosbuvir, velpatasvir, and voxilaprevir. These medications work together to decrease the amount of hepatitis C virus in the body and stop the virus from spreading. 

Vosevi comes as a tablet and is taken once daily with food. 

Common side effects of Vosevi include headache, diarrhea, and nausea. 

Vosevi is a prescription drug used to treat chronic hepatitis C virus in patients without cirrhosis (liver disease) or who have cirrhosis with no symptoms.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Gilead Sciences, Inc.

Serious side effects have been reported with Vosevi. See the “Vosevi Precautions” section.

Common side effects of Vosevi include the following:

• headache
• tiredness
• diarrhea
• nausea

This is not a complete list of Vosevi side effects. Ask your doctor or pharmacist for more information. Tell your doctor if you have any side effects that bother you or that do not go away. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• acid reducing agents such as esomeprazole (Nexium), lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole (Protonix), rabeprazole (Aciphex), cimetidine (Tagamet), famotidine (Pepcid), nizatidine (Axid), ranitidine (Zantac)
• antiarrhythmics, heart rate, medications such as amiodarone (Cordarone, Nexterone), digoxin (Lanoxin), procainamide (Procanbid, Procan), lidocaine (Xylocaine, Lidoderm), phenytoin (Dilantin), flecainide (Tambocor), sotalol (Betapace)
• anticoagulant, blood thinning, medications such as warfarin (Coumadin, Jantoven), heparin, enoxaparin (Lovenox), fondaparinux (Arixtra), rivaroxaban (Xarelto), and apixaban (Eliquis)
• anticonvulsant, seizure, medications such as carbamazepine (Tegretol), phenytoin (Dilantin), phenobarbital (Luminal), and oxcarbazepine (Trileptal)
• antimycobacterials such as rifabutin, rifampin, and rifapentine
• antiretrovirals such as efavirenz/emtricitabine/tenofovir (Atripla), rilpivirine (Edurant), emtricitabine (Emtriva), elvitegravir, cobicistat, emtricitabine, and tenofovir (Stribild), tenofovir and emtricitabine (Truvada), tenofovir (Viread), adefovir (Hepsera)
• herbal supplements such as St. John's Wort
• statin medications such as lovastatin (Mevacor), simvastatin (Zocor), rosuvastatin (Crestor), pravastatin (Pravachol), pitavastatin (Livalo), atorvastatin (Lipitor)
• immunosuppressants such as cyclosporine (Neoral, Gengraf, Sandimmune)
• antacid medications that contains aluminum or magnesium

This is not a complete list of Vosevi drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Vosevi including the following:

Hepatitis B Reactivation. Risk of hepatitis B virus returning in patients who have hepatitis C and hepatitis B viruses. All potential patients should be tested for hepatitis B prior to Vosevi treatment. 

Low Heart Rate with Amiodarone. Taking Vosevi with amiodarone can decrease your heart rate significantly. If you experience any of the following symptoms talk to your doctor: fainting, dizziness, weakness, excessive tiredness, chest pains, or memory problems. 

Drug Interactions. Use of specific medications can affect how well Vosevi works and are not recommended. See "Vosevi Drug Interactions" for more information. 

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Vosevi, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Vosevi, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Vosevi or to any of its ingredients
• have or have had kidney disease
• have or have had any other liver diseases
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

There are no well-done studies that have been done in humans with Vosevi. In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Vosevi crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. You and your doctor will decide if the benefits outweigh the risk of using Vosevi.

Take Vosevi exactly as prescribed. 

Vosevi comes as a tablet and is taken once daily with food. 

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Vosevi at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dose of Vosevi for the treatment of hepatitis C is one tablet which includes the following amounts of each drug:

• 400 mg sofosbuvir
• 100 mg velpatasvir
• 100 mg voxilaprevir

If you take too much Vosevi, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Vosevi at room temperature.
• Keep Vosevi and all medications out of the reach of children. 

WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV

Test all patients for evidence of current or prior hepatitis B virus infection before initiating treatment with Vosevi. Hepatitis B reactivation has been reported in patients infected with both viruses who have or have had hepatitis C treatment, but not hepatitis B treatment. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Monitor coinfected patients for hepatitis flare or hepatitis B reactivation during Vosevi treatment and post-treatment follow-up. Initiate appropriate patient management for hepatitis B infection as clinically indicated.