Vosevi (sofosbuvir/velpatasvir/voxilaprevir)

Vosevi generic

Vosevi is available only as a brand-name medication. It’s not currently available in generic form.

A generic drug is an exact copy of the active ingredient in a brand-name medication. An active ingredient is what makes a drug work. Generics usually cost less than brand-name drugs.

Vosevi side effects

Vosevi can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Vosevi. These lists don’t include all possible side effects.

For more information on the possible side effects of Vosevi, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be concerning or bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs they have approved. If you would like to report to the FDA a side effect you’ve had with Vosevi, you can do so through MedWatch.

More common side effects

The more common side effects of Vosevi can include:

• nausea
• fatigue
• feeling weak
• difficulty sleeping
• headache (see “Side effect details” below)
• diarrhea (see “Side effect details” below)

Most of these side effects may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Vosevi aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency phone number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects are discussed in more detail below. They include:

• allergic reaction
• reactivation of the hepatitis B virus in people with both hepatitis B and hepatitis C*
• severe liver damage or liver failure, in people with cirrhosis†

* Vosevi has a boxed warning for this side effect. This is the most serious warning from the Food and Drug Administration (FDA). For details, see the “Vosevi precautions” section below.
† This side effect has been reported since Vosevi became available for use. But because this wasn’t seen in clinical trials, it’s not clear whether Vosevi caused people’s liver damage or liver failure, or whether there may be other causes besides Vosevi.

Side effect details

You may wonder how often certain side effects occur with this drug. Here’s some detail on some of the side effects this drug may cause.

Headache

Headaches may occur with Vosevi use. This was the most common side effect reported in clinical trials.

If you get headaches while taking Vosevi, ask your pharmacist to recommend a pain reliever. If your headaches are severe or bothersome, be sure to talk with your doctor about other ways to manage them.

Diarrhea

Vosevi may cause diarrhea.

If you have diarrhea, make sure you drink plenty of fluids to avoid getting dehydrated.

Talk with your doctor if you have severe diarrhea (passing six or more watery stools in 24 hours), or diarrhea that lasts for more than a couple of days. They may recommend taking an antidiarrheal medication to manage it.

ALLERGIC REACTION

For some people, Vosevi can cause an allergic reaction. It’s not known how often this occurs. It wasn’t reported in clinical studies of Vosevi.

In general, symptoms of an allergic reaction can be mild or serious. You can learn more about possible symptoms in this article.

Ways to manage

For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should keep taking the medication.

For severe allergic reaction symptoms, such as swelling or difficulty breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to Vosevi, your doctor may recommend taking a different medication instead.

Vosevi dosage

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Vosevi comes as a tablet that contains 400 mg of sofosbuvir, 100 mg of velpatasvir, and 100 mg of voxilaprevir.

Dosage for chronic hepatitis C

The recommended dosage is one Vosevi tablet taken once a day for 12 weeks. You should take Vosevi with food.

What if I miss a dose?

It’s important that you don’t miss or skip doses of Vosevi and that you take the full course of treatment. Missing doses or not completing the course will make Vosevi less effective against the hepatitis C virus. This could mean that your hepatitis C won’t be cured.

To help make sure you don’t miss a dose, try setting a reminder on your phone.

If you forget to take a dose at your usual time, take it as soon as you remember that day. But if you don’t remember until the following day, just take your regular dose. Never take two doses to make up for a missed dose. This could raise your risk of getting side effects.

Will I need to use this drug long term?

No. Vosevi is meant to be used as one 12-week course of treatment.

Sticking to your Vosevi treatment plan

It’s very important that you take Vosevi every day for 12 weeks. This will give you the best chance of curing your hepatitis C. It also will lower your risk of getting long-term complications from the disease, such as liver cirrhosis (scarring), liver failure, or liver cancer.

You should keep taking Vosevi for the entire time that your doctor recommends, even if you feel better before you finish the full course of treatment.

When you start treatment, pick a time of day that’s most convenient for you to take Vosevi.

Getting in a routine for taking your medication will help you remember it. Setting a reminder on your phone can be helpful, too. Also, remember to take your medication with you if you’re going away somewhere.

Talk with your doctor if you think you’ll find it difficult to remember to take Vosevi every day.

Note: You can refer to this Vosevi dosage article for details.

Vosevi and alcohol

You should avoid drinking alcohol while you’re taking Vosevi. Drinking alcohol could cause further damage to your liver. It can also increase your risk of Vosevi side effects such as headaches, diarrhea, nausea, and fatigue.

Talk with your doctor if you’re concerned about avoiding alcohol during your Vosevi treatment.

Vosevi interactions

Vosevi can interact with several other medications. It can also interact with certain supplements.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase side effects or make them more severe.

Vosevi and other medications

Below is a list of medications that can interact with Vosevi. This list doesn’t contain all drugs that may interact with Vosevi.

Before taking Vosevi, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information helps you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Vosevi and antacids

Antacids are drugs that relieve indigestion or heartburn. Taking Vosevi at the same time of day as an antacid can lower the amount of velpatasvir that your body absorbs. (Velpatasvir is one of the drugs in Vosevi.) This could make Vosevi less effective.

Examples of antacids that can make Vosevi less effective include:

• sodium bicarbonate (an ingredient in some Alka-Seltzer products)
• aluminum hydroxide/magnesium hydroxide/simethicone liquid (Maalox, Mylanta)
• calcium carbonate/magnesium hydroxide (Rolaids)
• calcium carbonate (Tums)

To avoid this interaction, don’t take antacids in the 4 hours before or after you take your dose of Vosevi.

Vosevi and amiodarone

Amiodarone (Nexterone, Pacerone) is a drug used to treat serious types of irregular heartbeat.

Taking Vosevi with amiodarone can cause bradycardia (dangerously slow heartbeat). Some people taking these medications together in clinical trials needed a pacemaker to keep their heart beating regularly.

Vosevi is not recommended for people taking amiodarone unless there are no other options. If you have to take Vosevi and amiodarone together, your doctor will closely monitor your heart.

Vosevi and digoxin

Digoxin (Lanoxin) is a drug used to treat certain heart problems, including heart failure.

Taking Vosevi with digoxin can make the level of digoxin in your blood rise too high. This could cause serious side effects from the digoxin.

If you have to take Vosevi with digoxin, you’ll need to have blood tests to monitor your digoxin level. If it gets too high, your doctor will likely lower your digoxin dose.

Vosevi and warfarin

Warfarin (Jantoven) is an anticoagulant (blood thinner) that treats and helps prevent blood clots. It works by reducing the production of proteins called clotting factors. Clotting factors help make your blood clot. They’re made by your liver.

Your liver may start to work better as Vosevi treats your hepatitis C. This can change how many clotting factors your liver makes.

As a result, it might change the effect of warfarin in your blood. If you’re taking Vosevi with warfarin, you may need extra blood tests to monitor how long it takes your blood to clot. Your doctor may increase or decrease your warfarin dose as needed.

Vosevi and dabigatran

Taking Vosevi with a blood thinner called dabigatran (Pradaxa) can increase the level of dabigatran in your blood. This can raise your risk of side effects from dabigatran, such as bruising or bleeding.

If you need to take Vosevi with dabigatran, tell your doctor if you notice you’re bruising or bleeding more easily than usual.

For example, tell them if you get bruises you can’t explain, cuts that take a long time to stop bleeding, nosebleeds that last a long time, or blood in your urine. Your doctor may need to lower your dabigatran dose.

Vosevi and certain cholesterol medications

Taking Vosevi with cholesterol-lowering medications called statins can increase the level of the statin in your blood. This can raise your risk of getting side effects from the statin, in particular muscle problems.

Examples of statin medications include:

• atorvastatin (Lipitor)
• fluvastatin (Lescol XL)
• lovastatin (Altoprev)
• pitavastatin (Livalo, Zypitamag)
• pravastatin (Pravachol)
• rosuvastatin (Ezallor, Crestor)
• simvastatin (Flolipid, Zocor)

If you’re taking a statin, talk with your doctor before you start treatment with Vosevi. Your doctor may need to lower the dose of your statin while you take Vosevi.

However, if you’re taking pitavastatin or rosuvastatin, your doctor may switch you to a different statin. These two statins are not recommended for use with Vosevi.

Vosevi and certain seizure medications

Taking certain seizure medications with Vosevi can lower the amount of Vosevi in your body. This can make Vosevi less effective.

Examples of seizure medications that can make Vosevi less effective include:

• carbamazepine (Carbatrol, Equetro, Tegretol, Epitol)
• oxcarbazepine (Trileptal, Oxtellar XR)
• phenobarbital
• phenytoin (Dilantin, Phenytek)

These are not recommended for use with Vosevi.

If you’re taking one of these medications, talk with your doctor before you start treatment with Vosevi. Your doctor may need to change your treatment.

Vosevi and certain antibiotics

Taking certain antibiotics with Vosevi can lower the amount of Vosevi in your body and make it less effective. To avoid this interaction, the following antibiotics should not be taken with Vosevi:

• rifabutin (Mycobutin)
• rifampin (Rifadin, Rimactane, Rifamate, Rifater)
• rifapentine (Priftin)

Vosevi and certain HIV drugs

Vosevi can interact with certain types of HIV drugs. Talk with your doctor if you take an HIV drug and want to take Vosevi.

Atazanavir (Reyataz, Evotaz) or lopinavir (Kaletra)

HIV drugs containing atazanavir or lopinavir can increase the amount of voxilaprevir (one of the drugs in Vosevi) in your body. This could raise your risk of certain side effects. Taking Vosevi with atazanavir or lopinavir is not recommended.

Tipranavir (Aptivus) or ritonavir (Norvir, Kaletra)

HIV drugs containing tipranavir or ritonavir can lower the amount of sofosbuvir and velpatasvir (two of the drugs in Vosevi) in your body. This could make Vosevi less effective. Vosevi is not recommended for use with tipranavir or ritonavir.

Efavirenz (Sustiva, Atripla, Symfi)

HIV drugs containing efavirenz can lower the amount of velpatasvir and voxilaprevir (two of the drugs in Vosevi) in your body. This could make Vosevi less effective. Taking Vosevi with drugs containing efavirenz is not recommended.

Tenofovir disoproxil fumarate (Viread, Truvada, others)

Taking Vosevi with HIV drugs containing tenofovir disoproxil fumarate can increase the amount of tenofovir in your body. This could raise your risk of side effects. If you have to take these drugs together, your doctor may need to monitor you closely.

Vosevi and cyclosporine

Cyclosporine (Gengraf, Neoral, Sandimmune) is an immunosuppressant drug that reduces your immune system activity.

Taking Vosevi with cyclosporine could increase the amount of voxilaprevir (one of the drugs in Vosevi) in your body. This could raise your risk of side effects. Taking Vosevi with cyclosporine is not recommended.

Vosevi and herbs and supplements

Taking Vosevi with the herbal supplement St. John’s wort (Hypericum perforatum) can lower the amount of Vosevi in your body. This could make it less effective. Avoid taking St. John’s wort while you’re taking Vosevi.

Check with your doctor or pharmacist before using any herbs or supplements while taking Vosevi.

Vosevi for chronic hepatitis C

Vosevi is FDA-approved to treat chronic (long-lasting) hepatitis C in adults, when certain other treatments haven’t worked.

Hepatitis C is a liver disease caused by infection with the hepatitis C virus (HCV). There are six main strains of this virus, which are called genotypes.

Vosevi is approved to treat chronic hepatitis C caused by:

• genotypes 1, 2, 3, 4, 5, and 6 in people who have tried antiviral drugs called nonstructural protein 5A (NS5A) inhibitors such as elbasvir, ledipasvir, ombitasvir, or velpatasvir
• genotype 1a or 3 in people who have tried the antiviral drug called sofosbuvir, taken without an NS5A inhibitor

Hepatitis C causes liver inflammation and damage to the liver. It can lead to liver cirrhosis (scarring) and liver failure.

Vosevi is approved for use in:

• people who don’t have cirrhosis
• people with compensated cirrhosis (where the liver is damaged but can still carry out its basic functions)

Effectiveness

In two clinical studies, Vosevi cured chronic hepatitis C in the majority of people who took it for 12 weeks.

In these studies, the participants had blood tests to check for hepatitis C before, during, and after treatment with Vosevi. People were considered cured of hepatitis C if no virus was detected in their blood 12 weeks after they completed treatment.

Alternatives to Vosevi

Other drugs are available that can treat hepatitis C. Some may be a better fit for you than others. If you’re interested in finding an alternative to Vosevi, talk with your doctor. They can tell you about other medications that may work well for you.

Alternatives for chronic hepatitis C

Examples of other drugs that may be used to treat chronic (long-lasting) hepatitis C include:

Other direct-acting antivirals, such as:

• elbasvir/grazoprevir (Zepatier)
• glecaprevir/pibrentasvir (Mavyret)
• ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira Pak)
• sofosbuvir (Sovaldi)
• sofosbuvir/ledipasvir (Harvoni)
• sofosbuvir/velpatasvir (Epclusa)

Older, less commonly used medications, such as:

• peginterferon alfa-2a (Pegasys)
• peginterferon alfa-2b (Pegintron)
• ribavirin (Rebetol, Ribasphere)

Vosevi vs. Epclusa

You may wonder how Vosevi compares to other medications that are prescribed for similar uses. Here we look at how Vosevi and Epclusa are alike and different.

Ingredients

Vosevi contains three active drugs: sofosbuvir, velpatasvir, and voxilaprevir. Epclusa contains two active drugs: sofosbuvir and velpatasvir.

Uses

Vosevi and Epclusa are both approved to treat chronic (long-lasting) hepatitis C in adults. Epclusa is also approved for use in children ages 3 years and older. Both can be used to treat all six main genotypes (strains) of the hepatitis C virus (HCV).

Vosevi is approved for use in people who have tried certain hepatitis C drugs in the past without success. Vosevi is specifically approved to treat:

• people with HCV genotype 1, 2, 3, 4, 5, or 6 who have tried antiviral drugs called nonstructural protein 5A (NS5A) inhibitors
• people with HCV genotype 1a or 3 who have tried an antiviral drug called sofosbuvir, taken without an NS5A inhibitor

Vosevi and Epclusa are both approved for use in:

• people without liver cirrhosis (scarring)
• people with compensated cirrhosis (where the liver is damaged but still able to perform its basic functions)

Epclusa is also approved for use in people with decompensated cirrhosis (where the damage to the liver stops it from working properly). In this situation, Epclusa is used with another antiviral drug called ribavirin.

Drug forms and administration

Both Vosevi and Epclusa come as tablets that you take by mouth once daily for 12 weeks.

Side effects and risks

Vosevi and Epclusa both contain sofobuvir and velpatasvir. Therefore, these medications can cause very similar side effects. Below are examples of these side effects.

More common side effects

These lists contain examples of more common side effects that can occur with Vosevi or with both drugs (when taken individually).

• Can occur with Vosevi:
  • diarrhea
• Can occur with both Vosevi and Epclusa:
  • headache
  • fatigue
  • nausea
  • feeling weak
  • difficulty sleeping

Serious side effects

This list contains examples of serious side effects that can occur with both Vosevi and Epclusa (when taken individually).

• Can occur with both Vosevi and Epclusa:
  • allergic reaction
  • reactivation of hepatitis B virus in people with both hepatitis B and hepatitis C*

* Vosevi and Epclusa both have a boxed warning for this side effect. This is the most serious warning from the Food and Drug Administration (FDA). For details about Vosevi’s warning, see the “Vosevi precautions” section below.

Effectiveness

The use of Vosevi and Epclusa in treating chronic hepatitis C has been directly compared in a clinical study. This study only looked at people who had previously tried treatment with other direct-acting antivirals (the main type of hepatitis C drugs used) but who hadn’t taken an NS5A inhibitor before.

Researchers found that in people with this treatment history, Vosevi was more effective than Epclusa at curing hepatitis C genotypes 1a and 3. The study didn’t compare how effective these drugs are in people with genotype 4, 5, or 6.

Talk with your doctor about whether Vosevi or Epclusa is likely to be more effective for you.

Costs

Vosevi and Epclusa are both brand-name drugs. There’s currently no generic form of Vosevi. Epclusa comes as a generic called sofosbuvir/velpatasvir. Brand-name medications usually cost more than generics.

The generic form of Epclusa might be less expensive than either brand-name drug. The actual price you’ll pay for either drug will depend on your insurance plan, your location, and the pharmacy you use.

Vosevi vs. Mavyret

Like Epclusa (above), Mavyret has uses similar to those of Vosevi.

Here’s a comparison of how Vosevi and Mavyret are alike and different.

Ingredients

Vosevi contains three active drugs: sofosbuvir, velpatasvir, and voxilaprevir. Mavyret contains two active drugs: glecaprevir and pibrentasvir.

Uses

Vosevi and Mavyret are both approved to treat chronic (long-lasting) hepatitis C in adults. Mavyret is also approved for use in children ages 3 years and older. Both can be used to treat the six main genotypes (strains) of the hepatitis C virus (HCV).

Vosevi is approved to treat:

• people with HCV genotype 1, 2, 3, 4, 5, or 6 who have tried antiviral drugs called nonstructural protein 5A (NS5A) inhibitors
• people with HCV genotype 1a or 3 who have tried an antiviral drug called sofosbuvir, taken without an NS5A inhibitor

Mavyret is approved to treat:

• people with HCV genotype 1, 2, 3, 4, 5, or 6
• people with HCV genotype 1 who have tried antiviral drugs called NS5A inhibitors or NS3/4A protease inhibitors, but not both

Vosevi and Mavyret are both approved for use in:

• people without liver cirrhosis (scarring)
• people with compensated cirrhosis (where the liver is damaged but still able to perform its basis functions)

Drug forms and administration

Vosevi and Mavyret both come as tablets that you take by mouth once daily.

Vosevi is taken for 12 weeks. Mavyret is taken for either 8, 12, or 16 weeks. Your treatment length will depend on what treatment you’ve already had and whether you have cirrhosis.

Side effects and risks

Vosevi and Mavyret have some similar side effects and others that differ. Below are examples of these side effects.

More common side effects

These lists contain examples of more common side effects that can occur with Vosevi, with Mavyret, or with both drugs (when taken individually).

• Can occur with Vosevi:
  • feeling weak
  • difficulty sleeping
• Can occur with Mavyret:
  • itching
  • feeling weak (in people on dialysis)
• Can occur with both Vosevi and Mavyret:
  • headache
  • fatigue
  • nausea
  • diarrhea

Serious side effects

This list contains examples of serious side effects that can occur with Vosevi or Mavyret (when taken individually).

• Can occur with both Vosevi and Mavyret:
  • allergic reaction
  • reactivation of hepatitis B virus in people with both hepatitis B and hepatitis C*

*Vosevi and Mavyret both have a boxed warning for this side effect. This is the most serious warning from the Food and Drug Administration (FDA). For details about Vosevi’s warning, see the “Vosevi precautions” section below.

Effectiveness

Vosevi and Mavyret haven’t been directly compared in clinical studies. However, studies have found both Vosevi and Mavyret to be highly effective for treating chronic hepatitis C caused by the six main genotypes. They’re both recommended in current treatment guidelines for hepatitis C.

Your doctor may recommend either drug, depending on your medical history and treatment history.

Costs

Vosevi and Mavyret are both brand-name drugs. There are currently no generic forms of either drug. Brand-name medications usually cost more than generics. The actual price you’ll pay for either drug will depend on your treatment length, your insurance plan, your location, and the pharmacy you use.

Vosevi cost

As with all medications, the cost of Vosevi can vary.

The actual price you’ll pay will depend on your insurance plan, your location, and the pharmacy you use.

It’s important to note that Vosevi is only available at specialty pharmacies. These are pharmacies authorized to carry specialty medications (drugs that are complex, have high prices, are difficult to take, or have special dosage or storage requirements).

Your insurance plan may require you to get prior authorization before it approves coverage for Vosevi.

This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the request and let you and your doctor know if your plan will cover Vosevi.

If you’re not sure if you’ll need to get prior authorization for Vosevi, contact your insurance plan.

Financial and insurance assistance

If you need financial support to pay for Vosevi, or if you need help understanding your insurance coverage, help is available.

A Support Path program is available for Vosevi. For more information and to find out if you’re eligible for support, call 855-7-MYPATH (855-769-7284) or visit the program website.

Note: You can refer to this Vosevi cost article for details.

How to take Vosevi

You should take Vosevi according to your doctor’s or healthcare professional’s instructions.

When to take

You should take Vosevi once a day with food. You can take it at any time of day, but try to always take it at the same time. Getting in a routine can help you remember to take your dose each day.

To help make sure you don’t miss a dose, try setting a reminder on your phone. A medication timer may be useful, too.

Taking Vosevi with food

Take Vosevi with food (either a meal or a snack). This helps your body absorb the medication.

Can Vosevi be crushed, split, or chewed?

You should not crush, split, or chew Vosevi tablets because they have a very bitter taste. Also, the effect of crushing, chewing, or breaking Vosevi hasn’t been studied.

It could affect the way your body absorbs the medication. It’s not known if this would change how safe or effective the drug is.

If you have difficulty swallowing Vosevi tablets whole, talk with your doctor about your options for other treatments.

How Vosevi works

Vosevi is approved to treat chronic (long-lasting) hepatitis C in adults whose disease hasn’t been cured by taking certain other antiviral drugs.

About hepatitis C

Hepatitis C infection is caused by the hepatitis C virus (HCV). You can contract this virus through contact with the blood or bodily fluids containing the blood of a person who has HCV.

Once inside your body, the virus multiplies by making copies of itself inside your liver cells. This causes inflammation (swelling and damage) to your liver.

Sometimes, your immune system can fight off the hepatitis C virus itself. However, in about 75% to 85% of people, this doesn’t happen, and the infection becomes chronic.

Without treatment, chronic hepatitis C infection can lead to liver cirrhosis (scarring), liver failure, and liver cancer.

What Vosevi does

Vosevi is a type of drug called a direct-acting antiviral. It contains three active drugs: sofosbuvir, velpatasvir, and voxilaprevir. Each of these drugs works in a slightly different way to stop the hepatitis C virus from making copies of itself.

The hepatitis C virus uses certain proteins within the virus to make copies of itself. Each of the drugs in Vosevi stops a different protein from working. This means the virus can’t multiply.

Viruses that can’t make copies of themselves eventually die or are removed by your immune system. This clears up the infection and prevents further damage to your liver.

How long does it take to work?

Vosevi will start working right away, but you’ll need to take the full 12-week course of treatment to cure the infection.

In a clinical study, hepatitis C was cured in 96% of people who took Vosevi for 12 weeks.

Your doctor will test your blood for the virus during treatment and 12 weeks after you finish treatment. If the virus is not detected in your blood 12 weeks after your treatment ends, you’re considered cured of hepatitis C.

Vosevi and pregnancy

It’s not known if Vosevi is safe to take during pregnancy. It hasn’t been studied in pregnant people.

Studies in animals didn’t show harm to the fetus when the pregnant animals were given any of the active drugs in Vosevi. However, studies in animals don’t always predict what’ll happen in humans.

If you’re pregnant or considering becoming pregnant, talk with your doctor about your treatment options.

Vosevi and birth control

As mentioned above, it’s unknown if Vosevi is safe for use during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Vosevi.

Vosevi and breastfeeding

It’s not known if Vosevi is safe to take while breastfeeding. It’s unknown if the active drugs in Vosevi pass into human breast milk.

In animal studies, the drugs were found in animal milk. However, studies in animals don’t always predict what’ll happen in humans.

If you’re breastfeeding, talk with your doctor about the risks and benefits of taking Vosevi.

Common questions about Vosevi

Here are answers to some frequently asked questions about Vosevi.

Why can’t I get Vosevi at my local pharmacy?

Vosevi is only available at specialty pharmacies, which are authorized to carry specialty medications. These are drugs that are complex, have high prices, are difficult to take, or have special dosage or storage requirements.

Ask your doctor if you aren’t sure where you can get Vosevi. They can recommend a specialty pharmacy in your area that carries it.

Will my doctor give me any tests before I take Vosevi?

Yes, your doctor will do blood tests to check for the hepatitis B virus before you start treatment.

If these tests show you have the hepatitis B virus, you may need to take medication to treat it. This is because taking Vosevi can make the hepatitis B virus become active in your body again, which can lead to liver failure and death. Vosevi has a boxed warning for this side effect. (For details, see the “Vosevi precautions” section below.)

Your doctor will also do blood tests to check your liver function. If the tests show your liver is not working very well, you may not be able to take Vosevi.

Is it OK to use antacids during my Vosevi treatment?

Yes, you can take antacids during your treatment. However, do not take them in the 4 hours before or after you take your Vosevi dose.

Be sure to talk with your doctor about taking antacids with Vosevi, and follow their instructions.

Can Vosevi cure hepatitis C?

Yes, taking Vosevi for 12 weeks can cure hepatitis C in most people who have tried other treatments that haven’t worked.

In one study, Vosevi cured hepatitis C in 96% of people who had tried a type of drug called a nonstructural protein 5A (NS5A) inhibitor. In a second study, Vosevi cured hepatitis C in 97% of people who had previously tried sofosbuvir without an NS5A inhibitor.

If you have questions about what to expect with Vosevi treatment, talk with your doctor.

Vosevi precautions

This drug comes with several precautions.

FDA warning: Reactivation of hepatitis B virus

This drug has a boxed warning. This is the most serious warning from the Food and Drug Administration (FDA). A boxed warning alerts doctors and patients about drug effects that may be dangerous.

If you’ve ever had hepatitis B, there’s a risk that taking Vosevi could reactivate the hepatitis B virus in your body. Reactivation is when the virus becomes active again. It can lead to liver failure and death.

Your doctor will do blood tests to check for the hepatitis B virus before you start treatment with Vosevi. If these tests show you have the hepatitis B virus, you may need to take medication to treat it.

Other precautions

Before taking Vosevi, talk with your doctor about your health history. Vosevi may not be right for you if you have certain medical conditions or other factors affecting your health. Be sure to talk with your doctor if any of the following apply to you:

• treatment with rifampin (Rifadin, Rimactane, Rifamate, Rifater)
• treatment with amiodarone (Nexterone, Pacerone) for heart problems
• current or past liver problems
• pregnancy
• breastfeeding
• previous allergic reaction to this or a similar drug

Note: For more information about the potential negative effects of Vosevi, see the “Vosevi side effects” section above.

Vosevi overdose

Do not use more Vosevi than your doctor recommends.

If you think you’ve taken too much of this drug, call your doctor. You can also call America’s Poison Centers at 800-222-1222 or use its online tool.

If your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.