Vosevi (sofosbuvir/velpatasvir/voxilaprevir) is a prescription drug used to treat chronic (long lasting) hepatitis C infection. Vosevi can cause side effects that range from mild to serious. Examples include headache, fatigue, and diarrhea.

Vosevi is used to treat various types of chronic hepatitis C in adults who do not have cirrhosis (scarring of the liver). It’s also used for this purpose in adults who have compensated cirrhosis (liver scarring that doesn’t cause symptoms). Doctors only prescribe Vosevi after you’ve tried other treatments for hepatitis C.

Vosevi comes as an oral tablet and contains the active ingredients sofosbuvir, velpatasvir, and voxilaprevir. These are three antiviral drugs used to treat hepatitis C.

Keep reading to learn about common, mild, and serious side effects Vosevi can cause. For a general overview of the drug, including details about its uses, see this article.

Some people may experience mild to serious side effects during Vosevi treatment. Examples of the drug’s commonly reported side effects include:

Mild side effects have been reported with Vosevi. These include:

In most cases, these side effects should be temporary. And some may be easily managed. But if you have symptoms that are ongoing or bothersome, talk with your doctor or pharmacist. And do not stop taking Vosevi unless your doctor recommends it.

Vosevi may cause mild side effects other than those listed above. See the drug’s prescribing information for details.

* To learn more about this side effect, see the “Side effects explained” section below.
† An allergic reaction is possible after taking Vosevi, but it’s not clear whether this side effect occurred in studies.

Serious side effects have been reported with Vosevi. These include:

  • boxed warning: risk of reactivation of HBV*
  • severe allergic reaction*†

If you develop serious side effects while taking Vosevi, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.

* To learn more about this side effect, see the “Side effects explained” section below.
† An allergic reaction is possible after taking Vosevi, but it’s not clear whether this side effect occurred in studies.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. If you’d like to notify the FDA about a side effect you’ve had with Vosevi, visit MedWatch.

Learn more about some of the side effects Vosevi may cause.

Risk of reactivation of HBV

Vosevi has a boxed warning for the risk of reactivation of the hepatitis B virus (HBV). A boxed warning is the most serious warning from the FDA. If you have had an HBV infection in the past, taking Vosevi can cause this virus to become active again. This can cause the hepatitis B infection to return, which can lead to severe or life threatening liver problems. Symptoms may include:

What might help

Before you start Vosevi, your doctor will order a blood test to check for HBV. If the test shows you have the virus, they may prescribe a medication to treat it. They’ll also monitor you closely for HBV infection symptoms and signs of reactivation during and after your Vosevi treatment.

Allergic reaction

Like most drugs, Vosevi can cause an allergic reaction in some people. But it’s not clear whether this side effect occurred in studies.

Symptoms can be mild to serious and can include:

  • skin rash
  • itchiness
  • flushing (temporary warmth, redness, or deepening of skin color)
  • swelling under your skin (usually in your eyelids, lips, hands, or feet)
  • swelling of your mouth, tongue, or throat, which can make it hard to breathe

What might help

If you have mild symptoms of an allergic reaction, such as a mild rash, call your doctor right away. They may suggest a treatment to manage your symptoms. Examples include:

  • an oral antihistamine, such as Benadryl (diphenhydramine)
  • a product you apply to your skin, such as hydrocortisone cream

If your doctor confirms you’ve had a mild allergic reaction to Vosevi, they’ll decide whether you should continue taking it.

If you have symptoms of a severe allergic reaction, such as swelling or difficulty breathing, call 911 or your local emergency number right away. These symptoms could be life threatening and require immediate medical care.

If your doctor confirms you’ve had a serious allergic reaction to Vosevi, they may have you switch to a different treatment.

Keeping track of side effects

During your Vosevi treatment, consider taking notes on any side effects you’re having. You can then share this information with your doctor. This is especially helpful when you first start a new drug or combination of treatments.

Your side effect notes can include things such as:

  • what dose of the drug you were taking when you had the side effect
  • how soon you had the side effect after starting that dose
  • what were your symptoms
  • how did your symptoms affect your daily activities
  • what other medications you were taking
  • any other information you feel is important

Taking notes and sharing them with your doctor will help them determine how Vosevi affects you. They can then use this information to adjust your treatment plan if needed.

Below is important information you should consider before taking Vosevi.

Boxed warning: Risk of reactivation of HBV

Vosevi has a boxed warning for the risk of reactivation of HBV. A boxed warning is the most serious warning from the FDA. If you have had an HBV infection in the past, taking Vosevi can cause this virus to become active again. This can cause the hepatitis B infection to return, which can lead to severe or life threatening liver problems.

To learn more, see the “Side effects explained” section above.

Risk of taking Vosevi with rifampin

The antibiotic rifampin can affect how Vosevi works. Due to this risk, doctors usually will not prescribe Vosevi for someone who’s also receiving rifampin treatment.

Risk of slowed heart rate with amiodarone

Taking Vosevi with the drug amiodarone can cause a slow heart rate. Due to this risk, doctors usually will not prescribe Vosevi for someone who’s also taking amiodarone.

Other warnings

Vosevi can sometimes cause harmful effects in people with certain conditions. This is known as a drug-condition interaction. Other factors may also affect whether Vosevi is a suitable treatment option for you.

Talk with your doctor about your health history before starting this drug. Be sure to tell them if any of the following factors apply to you:

  • moderate to severe liver disease
  • HBV infection
  • slow heart rate
  • active infection
  • past allergic reaction to Vosevi
  • pregnancy
  • breastfeeding

Alcohol and Vosevi

There are no known interactions between alcohol and Vosevi, but excessive alcohol consumption can lead to liver problems. These include liver inflammation (swelling), liver failure, and cirrhosis (liver scarring).

Because hepatitis C can also cause these conditions, drinking alcohol during Vosevi treatment increases your risk of liver problems.

Drinking alcohol can also increase your risk of certain Vosevi side effects such as headache, fatigue, and nausea.

It’s best to avoid alcohol while taking Vosevi. If you have questions about how much, if any, is safe to consume during Vosevi treatment, talk with your doctor or pharmacist.

Pregnancy and breastfeeding with Vosevi

There is limited information about the safety of Vosevi use during pregnancy or while breastfeeding.

Pregnancy

It’s not known whether it’s safe to take Vosevi during pregnancy. If you’re pregnant or planning to become pregnant, talk with your doctor before starting Vosevi.

Breastfeeding

It isn’t known whether Vosevi is safe to take while breastfeeding. If you’re breastfeeding or planning to do so, talk with your doctor before starting this medication.

Like most drugs, Vosevi can cause a number of side effects that range from mild to serious. But most are temporary and go away after a few days to weeks. If you have questions about the side effects Vosevi can cause, talk with your doctor. Examples of questions to help get you started include:

  • Does my health history increase my risk of Vosevi side effects?
  • Can Vosevi slow my heart rate when taken alone?
  • If I experience nausea or diarrhea with Vosevi, will it likely go away after I’ve taken the drug for a while?

To learn more about Vosevi, see these articles:

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Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.