Vosevi contains sofosbuvir, velpatasvir, and voxilaprevir into one pill. Each component belongs to an antiviral class and works differently to prevent HCV from growing or making new viruses in your body.
Vosevi is available in tablet form.
What Is Vosevi Used For?
The Food and Drug Administration (FDA) approved Vosevi to treat chronic (lasting for more than six months) hepatitis C in people without decompensated cirrhosis. It helps prevent the hepatitis C virus (HCV) from growing or multiplying in your body.
Brand Name(s): Vosevi
Drug Availability: Prescription
Therapeutic Classification: Antiviral
Available Generically: No
Controlled Substance: N/A
Administration Route: Oral
Active Ingredient: Sofosbuvir, velpatasvir, and voxilaprevir
Dosage Form(s): Tablet
Decompensated cirrhosis means your liver has too much scarring, which can lead to complications.
HCV can cause both acute and chronic hepatitis. The acute condition is usually controlled in six months, but it could move to the chronic stage, which can last longer than six months or even years without proper treatment. Vosevi is intended for people previously treated but not cured of the viral infection.
Even if you have already finished your antiviral treatment for acute hepatitis C, your healthcare provider may still give you Vosevi because it is used for a chronic condition.
How to Take Vosevi
Before starting Vosevi, your healthcare provider will give you a blood test to check for previous or current infection of hepatitis B. This is because hepatitis B can return and cause serious liver problems during or after treatment with Vosevi. Therefore, your healthcare provider will regularly check your blood tests during the treatment.
Follow your prescriber’s directions on how to take Vosevi. Do not take the drug in larger or smaller amounts unless your healthcare provider tells you to.
One tablet of Vosevi contains 400 milligrams (mg) of sofosbuvir, 100 milligrams of velpatasvir, and 100 milligrams of voxilaprevir. Typical dosing is 1 tablet taken by mouth once a day.
It is important to take this medicine on a regular schedule. Do not stop taking it unless your healthcare provider tells you to. How long you have to take it is based on your specific condition. Typically, you’ll be prescribed to take it once a day for about three months.
You should take your dose with food. If you need to take a medicine or supplement containing aluminum or magnesium, take it either four hours before or after Vosevi.
Storage
Store Vosevi below 86 F and keep it away from exposure to moisture or heat. Do not store it in the bathroom. Keep the tablets out of the reach of children and pets to prevent accidental consumption.
What Are the Side Effects of Vosevi?
This is not a complete list of side effects, and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or a healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 800-FDA-1088.
Common Side Effects
Common side effects of Vosevi may include:
Headache Tiredness or loss of energy Diarrhea Nausea Insomnia or trouble sleeping
Severe Side Effects
Contact your healthcare provider immediately if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects can include the following:
Hepatitis B flare-up Serious liver problems Marked decrease in heart rate or bradycardia
Long-Term Side Effects
The following long-term complications may occur with Vosevi:
Liver problems leading to liver failure or death in some people with a history of cirrhosis: During treatment, watch for signs of liver damage, such as yellowing of the skin or whites of your eyes (jaundice), itchy skin, dark urine, upper stomach pain, and nausea or vomiting. Worsening heart problems in people taking certain heart medications, such as Pacerone (amiodarone), and slow heart rate (bradycardia): Watch for symptoms including but not limited to fainting or near-fainting, dizziness or lightheadedness, chest pains, and shortness of breath.
Dosage: How Much Vosevi Should I Take?
Modifications
In some cases, your healthcare provider may need to adjust the use of your treatment or dosage.
If you experience a serious side effect, you or your healthcare provider may send a report to the FDA’s MedWatch Adverse Event Reporting Program or by phone (800-332-1088).
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
For oral dosage form (tablets): For hepatitis C virus infection that has been previously treated with other medicines: Adults—One tablet (400 milligrams [mg] sofosbuvir, 100 mg velpatasvir, 100 mg voxilaprevir) once a day for 12 weeks. Children—Use and dose must be determined by your doctor.
For example, if you are pregnant, treatment might be delayed until after delivery. Use of the drug during pregnancy may only be considered if the benefits outweigh the potential risks. There is limited data on whether Vosevi is present in human breast milk during breastfeeding. Consult your healthcare provider if you are pregnant, plan to become pregnant soon, or are breastfeeding.
There is also limited information on Vosevi’s safety and effectiveness in children.
It is generally safe to take this medication at a regular dose if you have kidney problems or are 65 years or older. However, this medication is not recommended for those with moderate to severe liver problems.
Missed Dose
To treat your infection, it is important not to miss or skip doses of Vosevi and take the medication on a regular schedule.
If you miss a dose of Vosevi, take it as soon as you remember. Take the next dose at your regular time. If you are close to the time you would take your next dose, skip the missed dose.
Overdose: What Happens If I Take Too Much Vosevi?
Do not take more than the prescribed dose of Vosevi. There is no specific antidote available for an overdose of this medication. If you’ve taken more than the recommended dose, contact a healthcare provider or the Poison Control Center. You may need to be monitored for toxicity.
Precautions
What Are Reasons I Shouldn’t Take Vosevi?
Do not take Vosevi if you:
If someone collapses or isn’t breathing after taking Vosevi, call 911 immediately.
Do not take this medicine together with products containing rifampin (eg, Rifadin®, Rifamate®, Rifater®, Rimactane®). Using these medicines together may cause serious side effects.
If you have ever had a hepatitis B infection, the virus could become active again during treatment with sofosbuvir, velpatasvir, and voxilaprevir combination. You should be tested for hepatitis B infection before starting treatment with this medicine. Talk with your doctor if you have concerns.
This medicine may cause worsening of liver problems. Tell your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin while using this medicine.
Amiodarone can cause serious side effects (including cardiac arrest, slow heartbeat, or conditions that need a pacemaker) if used together with this medicine or other medicines containing sofosbuvir, or if you have used it recently. This is more likely to occur in patients with heart disease or advanced liver disease. Tell your doctor if you are taking amiodarone before using this medicine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John’s wort) or vitamin supplements.
Have moderate to severe liver problems. Are taking any medications that contain rifampin
What Other Medications Interact With Vosevi?
Vosevi may interact with other drugs. Before starting treatment, tell your healthcare provider about all your medications, including prescription or over-the-counter (OTC) medications, vitamins, and herbal products.
After taking Vosevi, it is broken down and absorbed into your body by a group of proteins (enzymes). This process is also known as drug metabolism. Other drugs may affect how these proteins act in your body, changing how you metabolize Vosevi.Certain drugs may decrease the breakdown of Vosevi in your body. As a result, the effects of Vosevi may be increased. These drugs include:
Azole antifungals, such as ketoconazole, Sporanox (itraconazole), and Diflucan (fluconazole) Macrolide antibiotics, such as Ery-Tab (erythromycin) and Biaxin XL (clarithromycin) HIV medications, such as Norvir (ritonavir), Kaletra (ritonavir and lopinavir), and Viracept (nelfinavir) Cyclosporine
Some drugs and substances can also increase the breakdown activity of Vosevi, which may reduce its effects in the body. These include:
Rifampin Dilantin (phenytoin) Tegretol (carbamazepine) Phenobarbital St. John’s wort
Vosevi may slow down the breakdown activity of other medications. As a result, the undesired effects of other medications may be increased. These drugs include:
Amiodarone Lanoxin (digoxin)
What Medications Are Similar?
Other medications may be used to treat HCV, including but not limited to:
Harvoni (ledipasvir and sofosbuvir) Epclusa (sofosbuvir and velpatasvir) Mavyret (glecaprevir and pibrentasvir)
The above list does not contain all antiviral medicines used for hepatitis C virus infection. Talk to your healthcare provider about all potential treatment options.
How Can I Stay Healthy While Taking Vosevi?
Take Vosevi as directed by your healthcare provider. Do not stop or change your treatment regimen unless your healthcare provider tells you to. It is important to take it regularly every day with food.
Vosevi contains three antiviral medications (sofosbuvir, velpatasvir, and voxilaprevir), while Epclusa only contains two antiviral medicines (sofosbuvir and velpatasvir).
Epclusa can be used in people with cirrhosis, including decompensated cirrhosis. However, Vosevi can only be used in people without decompensated cirrhosis.
Further, Epclusa can be used in adults and children 3 years and older, but Vosevi can only be used in adults.
Currently, there is a generic version of Epclusa available, but Vosevi is only available as a brand-name medication.
However, it’s still possible to be infected with the virus again after you have been cured. Although most people are cured of their infection after taking Vosevi, a small number of people might not respond well to Vosevi and require a different treatment.
Make sure you tell your healthcare team about all your medications, including prescription or OTC medications, vitamins, and herbal products, before starting the treatment. Vosevi can interact with other medications, potentially making it less effective or cause unwanted side effects.
Your healthcare provider will order blood tests to check your liver function before and during the treatment. You will also regularly be tested for hepatitis B.
Call your healthcare team immediately if you notice any signs of liver damage, such as jaundice, itchy skin, dark urine color, upper stomach pain, or nausea and vomiting.
The author would like to recognize and thank Yufeng Zhai for contributing to this article.
