Sovaldi is a brand-name prescription drug that's used to treat certain types of hepatitis C virus (HCV). This virus, which affects your liver, can sometimes lead to serious conditions, such as liver failure.

Sovaldi is used to treat the following types of chronic (long-lasting) HCV in adults:

  • type 1 or 4, when it's used in combination with pegylated interferon and ribavirin
  • type 2 or 3, when it's used in combination with ribavirin

In adults, Sovaldi can be used to treat:

  • HCV types 1, 2, 3, and 4 in people who've never been treated for HCV
  • HCV types 2 and 3 in people who've tried other treatments in the past that didn't work for them

Sovaldi is also approved for use in children ages 3 years and older with HCV type 2 or 3. It can be used to treat these types of HCV in children who either have never been treated for HCV or have tried other treatments in the past that didn't work for them.

For children, Sovaldi should be used in combination with ribavirin.

For both adults and children, Sovaldi can be prescribed for people without cirrhosis (liver scarring) or with compensated (mild) cirrhosis.

Sovaldi comes as tablets that are taken by mouth. It also comes as pellets, which can be sprinkled on food and taken by mouth. Sovaldi belongs to a class of medications called direct-acting antiviral drugs. It works to treat HCV by blocking the virus from multiplying (making more virus) inside your body.

Effectiveness

In clinical trials, Sovaldi has been found effective in successfully treating HCV. For information on the effectiveness of Sovaldi, see the "Sovaldi for chronic hepatitis C" section below.

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

Sovaldi contains the active drug sofosbuvir.

Sovaldi can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Sovaldi. These lists do not include all possible side effects.

For more information on the possible side effects of Sovaldi, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be 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 Sovaldi, you can do so through MedWatch.

More common side effects

The more common side effects of Sovaldi, when it's used in combination with both pegylated interferon and ribavirin, can include:

  • fatigue (lack of energy)
  • headache
  • nausea
  • trouble sleeping
  • anemia (low red blood cell level)

The more common side effects of Sovaldi, when it's used in combination with ribavirin, can include:

  • fatigue (lack of energy)
  • headache

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 Sovaldi aren't common, but they can occur. Call your doctor right away 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, which are discussed below in the section "Side effect details," include:

  • hepatitis B virus (HBV) reactivation (a flare-up of the virus if it's already inside your body)*
  • severe allergic reaction
* Sovaldi has a boxed warning from the FDA regarding the risk of hepatitis B reactivation. A boxed warning is the strongest warning the FDA requires. It alerts doctors and patients about drug effects that may be dangerous.

Side effect details

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

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Sovaldi. In clinical trials, there were no reports of allergic reactions in people taking the drug. Symptoms of a mild allergic reaction can include:

  • skin rash
  • itchiness
  • flushing (warmth and redness in your skin)

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your tongue, mouth, or throat
  • trouble breathing

Call your doctor right away if you have a severe allergic reaction to Sovaldi. Call 911 if your symptoms feel life threatening or if you think you're having a medical emergency.

Long-term side effects

People who took Sovaldi in clinical trials didn't report having long-term side effects from the medication. However, after finishing Sovaldi treatment, your liver will need to be monitored for a while. Your doctor will do this by checking certain blood tests.

Monitoring your liver function is important after being treated for hepatitis C virus (HCV). This is because even after you've completed treatment, you may still have symptoms of liver damage.

If you have questions about what you can expect after treatment with Sovaldi, talk with your doctor. They can discuss with you whether you might need to be monitored for liver problems after treatment.

Side effects after treatment

In clinical trials, there were no reports of side effects from Sovaldi in people who were no longer using the drug. However, HBV reactivation, a possible side effect of Sovaldi, may occur after you've completed treatment.

HBV reactivation is a flare-up of the hepatitis B virus. This condition only occurs if you were infected with the virus in the past. For more information on this condition, see the section below within "Side effect details" called "Hepatitis B reactivation."

It's important to continue seeing your doctor regularly after completing Sovaldi treatment. They can monitor you for HBV reactivation and address any concerns you might have after Sovaldi treatment.

Fatigue

Fatigue (lack of energy) is a possible side effect of Sovaldi. In clinical trials, after 12 weeks of treatment with Sovaldi and ribavirin, about 38% of people felt fatigued. In comparison, about 59% of people taking Sovaldi, ribavirin, and pegylated interferon felt fatigued. Of people taking only a placebo (no active drug), 24% reported fatigue.

If you're feeling more tired than usual while you're taking Sovaldi, talk with your doctor. They may recommend ways to decrease this side effect, such as having you take naps or change your sleep habits.

Headache

Some people had headaches while taking Sovaldi during clinical trials. The studies showed that about 24% of people taking Sovaldi and ribavirin for 12 weeks had headaches. In comparison, about 36% of people taking Sovaldi, ribavirin, and pegylated interferon had headaches. About 20% of people taking only a placebo (no active drug) had headaches during treatment.

If you have new or worsening headaches while you're taking Sovaldi, talk with your doctor. They can recommend ways to improve your discomfort.

Hepatitis B reactivation

Reactivation of hepatitis B virus (HBV) may occur during treatment for hepatitis C virus (HCV) if you have both HBV and HCV in your body. Sovaldi has a boxed warning from the Food and Drug Administration (FDA) regarding this risk. A boxed warning is the strongest warning the FDA requires. It alerts doctors and patients about drug effects that may be dangerous.

With HBV reactivation, the hepatitis B virus flares up and may cause symptoms. These symptoms include pain in your belly and yellowing of your skin or the whites of your eyes.

HBV reactivation has occurred in people taking drugs from the same class of drugs as Sovaldi (called direct-acting antiviral medications). But these people weren't taking drugs to treat HBV. However, HBV reactivation didn't happen during clinical trials in people taking Sovaldi.

Because of the possibility of HBV reactivation, it's important that your doctor checks you for HBV before you start any treatment for HCV. If you have both HBV and HCV, your doctor may monitor you more often during Sovaldi treatment to watch for HBV reactivation. Your doctor may also treat your HBV infection before you start taking Sovaldi or during Sovaldi treatment.

Side effects in children

During clinical studies, the side effects of Sovaldi in children 3 years and older were similar to those in adults. However, the most common side effect in children taking Sovaldi with ribavirin was loss of appetite.

Other drugs are available that can treat chronic (long-lasting) hepatitis C virus (HCV). Some may be a better fit for you than others. If you're interested in finding an alternative to Sovaldi, talk with your doctor. They can tell you about other medications that may work well for you.

Some alternative medications for HCV contain sofosbuvir (the active drug in Sovaldi). Examples of medications that contain sofosbuvir in combination with other drugs include:

  • ledipasvir/sofosbuvir (Harvoni)
  • sofosbuvir/velpatasvir (Epclusa)
  • velpatasvir/sofosbuvir/voxilaprevir (Vosevi)

Other combination medications that don't contain sofosbuvir can also be used to treat HCV. Examples of these medications include:

  • elbasvir/grazoprevir (Zepatier)
  • glecaprevir/pibrentasvir (Mavyret)
  • dasabuvir/ombitasvir/paritaprevir/ritonavir (Viekira Pak)

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

Ingredients

Both Sovaldi and Harvoni contain the drug sofosbuvir. However, Harvoni also contains the drug ledipasvir.

Uses

Sovaldi is approved by the Food and Drug Administration (FDA) to treat certain types of chronic (long-lasting) hepatitis C virus (HCV).

Sovaldi is used to treat the following types of chronic (long-lasting) HCV in adults:

  • type 1 or 4, when it's used in combination with pegylated interferon and ribavirin
  • type 2 or 3, when it's used in combination with ribavirin

In adults, Sovaldi can be used to treat:

  • HCV types 1, 2, 3, and 4 in people who've never been treated for HCV
  • HCV types 2 and 3 in people who've tried other treatments in the past that didn't work for them

Sovaldi is also approved for use in children ages 3 years and older with HCV type 2 or 3. It can be used to treat these types of HCV in children who either have never been treated for HCV or have tried other treatments in the past that didn't work for them.

For children, Sovaldi should be used in combination with ribavirin.

For both adults and children, Sovaldi can be prescribed for people without cirrhosis (liver scarring) or with compensated (mild) cirrhosis.

Harvoni is also FDA-approved to treat chronic HCV. It can be used in adults and children ages 3 years and older with the following types of HCV:

  • type 1, 4, 5, or 6 in people without cirrhosis or with compensated cirrhosis
  • type 1 in people with decompensated (severe) cirrhosis, when it's used in combination with ribavirin
  • type 1 or 4 in people who've had a liver transplant, but who either don't have cirrhosis or have compensated (mild) cirrhosis; for these people, Harvoni is used in combination with ribavirin

Harvoni can be used to treat HCV types 1, 4, 5, or 6 in people who've never been treated for HCV, or people who've tried other treatments in the past that didn't work for them.

Drug forms and administration

Both Sovaldi and Harvoni come as tablets that are taken by mouth once daily. They each also come as pellets, which can be sprinkled on food and taken by mouth.

Each medication can be taken with or without food. It's very important that you take either of these medications every day. This helps the drug to work properly so that it can successfully treat your HCV.

Side effects and risks

Sovaldi and Harvoni both contain the drug sofosbuvir. 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 Sovaldi (when it's used along with ribavirin, pegylated interferon, or both), with Harvoni, or with both drugs (when taken individually).

  • Can occur with Sovaldi:
    • nausea
    • trouble sleeping
    • anemia (low red blood cell level)
  • Can occur with Harvoni:
    • feeling weak
  • Can occur with both Sovaldi and Harvoni:
    • fatigue (lack of energy)
    • headache

Serious side effects

These lists contain examples of serious side effects that can occur when taking either Sovaldi (when it's used along with ribavirin, pegylated interferon, or both)or Harvoni individually.

  • hepatitis B virus (HBV) reactivation (a flare-up of the virus if it's already inside your body)*
  • severe allergic reaction
* Sovaldi and Harvoni each have a boxed warning from the FDA regarding the risk of hepatitis B reactivation. A boxed warning is the strongest warning the FDA requires. It alerts doctors and patients about drug effects that may be dangerous.

Effectiveness

Sovaldi and Harvoni are both approved to treat certain types of chronic (long-lasting) HCV. However, the drugs may each be used to treat different types of HCV.

Sovaldi and Harvoni have been directly compared in a clinical study. In this study, treatment was considered successful if there was no HCV found in people's blood 12 weeks after they'd completed treatment.

In the study, 87.9% of people with type 2 HCV who took Sovaldi with ribavirin were successfully treated. In comparison, 96.3% of people with type 1 or type 6 HCV who took Harvoni were successfully treated.

Costs

Sovaldi and Harvoni are both brand-name drugs. There is currently a generic form of Harvoni available, but there isn't a generic form of Sovaldi. Brand-name medications usually cost more than generics.

According to estimates on GoodRx.com, the generic form of Harvoni is less expensive than either Sovaldi or brand-name Harvoni. But brand-name Harvoni costs more than brand-name Sovaldi. The actual price you'll pay for either drug depends on your treatment length, your insurance plan, your location, and the pharmacy you use.

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

Ingredients

Both Sovaldi and Epclusa contain the drug sofosbuvir. However, Epclusa also contains the drug velpatasvir.

Uses

Sovaldi is approved by the Food and Drug Administration (FDA) to treat certain types of chronic (long-lasting) hepatitis C virus (HCV).

Sovaldi is used to treat the following types of chronic (long-lasting) HCV in adults:

  • type 1 or 4, when it's used in combination with pegylated interferon and ribavirin
  • type 2 or 3, when it's used in combination with ribavirin

In adults, Sovaldi can be used to treat:

  • HCV types 1, 2, 3, and 4 in people who've never been treated for HCV
  • HCV types 2 and 3 in people who've tried other treatments in the past that didn't work for them

Sovaldi is also approved for use in children ages 3 years and older with HCV type 2 or 3. It can be used to treat these types of HCV in children who either have never been treated for HCV or have tried other treatments in the past that didn't work for them.

For children, Sovaldi should be used in combination with ribavirin.

For both adults and children, Sovaldi can be prescribed for people without cirrhosis (liver scarring) or with compensated (mild) cirrhosis.

Epclusa is also FDA-approved to treat chronic HCV in adults. It can be used in people who've never been treated for HCV or in people whose past HCV treatments didn't work for them. It's approved to treat all six types of HCV in people who either don't have cirrhosis or have compensated (mild) cirrhosis.

If Epclusa is given to people with decompensated (severe) cirrhosis, it should be used in combination with ribavirin.

Epclusa is not approved for use in children.

Drug forms and administration

Both Sovaldi and Epclusa come as tablets that are taken by mouth once daily. Sovaldi also comes as pellets, which can be sprinkled on food and taken by mouth.

Each medication can be taken with or without food. It's very important that you take either medication every day. This helps the drug to work properly so that it can successfully treat your HCV.

Side effects and risks

Sovaldi and Epclusa both contain the active drug sofosbuvir. 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 Sovaldi (when it's used along with ribavirin, pegylated interferon, or both), with Epclusa (when it's used alone or with ribavirin), or with both drugs (when taken individually).

  • Can occur with Sovaldi:
    • no unique serious side effects
  • Can occur with Epclusa:
    • diarrhea
  • Can occur with both Sovaldi and Epclusa:
    • headache
    • fatigue (lack of energy)
    • anemia (low red blood cell level)
    • nausea
    • trouble falling asleep

Serious side effects

These lists contain examples of serious side effects that can occur when taking either Sovaldi (when it's used along with ribavirin and pegylated interferon) or Epclusa individually.

  • hepatitis B virus (HBV) reactivation (a flare-up of the virus if it's already inside your body)*
  • severe allergic reaction
* Sovaldi and Epclusa each have a boxed warning from the FDA regarding the risk of hepatitis B reactivation. A boxed warning is the strongest warning the FDA requires. It alerts doctors and patients about drug effects that may be dangerous.

Effectiveness

Sovaldi and Epclusa are both approved to treat certain types of chronic (long-lasting) HCV infection. However, Epclusa treats all 6 types of HCV, while Sovaldi treats only 4 types.

The use of Sovaldi and Epclusa in treating HCV has been directly compared in a clinical study. In this study, treatment was considered successful if there was no HCV found in people's blood 12 weeks after they'd completed treatment.

About 88% of people with type 2 HCV who took Sovaldi with ribavirin were successfully treated. In comparison, about 99% of people taking Epclusa were successfully treated. People taking Epclusa had HCV types 1, 2, 3, 4, 5, or 6. But for some people taking Epclusa, their HCV type wasn't known.

Costs

Sovaldi and Epclusa are both brand-name drugs. There is a generic form of Epclusa available. However, there isn't a generic form of Sovaldi. Brand-name medications usually cost more than generics.

According to estimates on GoodRx.com, the generic form of Epclusa is less expensive than brand-name Epclusa and brand-name Sovaldi. And brand-name Epclusa costs less than Sovaldi costs. The actual price you'll pay for either drug depends on your treatment length, your insurance plan, your location, and the pharmacy you use.

The Food and Drug Administration (FDA) approves prescription drugs such as Sovaldi to treat certain conditions.

Sovaldi is FDA-approved to treat certain types of chronic (long-lasting) hepatitis C virus (HCV) in adults and children.

What is hepatitis C virus?

HCV is a virus that infects your liver. Over time, HCV can lead to very serious conditions such as cirrhosis (liver scarring) and liver cancer.

HCV is transmitted through blood that contains the virus. It's possible to get HCV from sharing used needles with someone who has HCV or by being born to a mother who has HCV. More rarely, you can get HCV by having sex with someone who has HCV or by sharing with them items that have blood on the surface.

Symptoms of HCV can include:

  • belly pain
  • nausea or vomiting
  • yellowing of your skin or the whites of your eyes
  • fever
  • fatigue (lack of energy)

What does Sovaldi treat?

Sovaldi is approved to treat certain types of HCV in people who either don't have cirrhosis (liver scarring) or who have compensated (mild) cirrhosis. (With mild cirrhosis, you don't any symptoms of the condition.)

Sovaldi is used to treat the following types of chronic (long-lasting) HCV in adults:

  • type 1 or 4, when it's used in combination with pegylated interferon and ribavirin
  • type 2 or 3, when it's used in combination with ribavirin

In adults, Sovaldi can be used to treat:

  • HCV types 1, 2, 3, and 4 in people who've never been treated for HCV
  • HCV types 2 and 3 in people who've tried other treatments in the past that didn't work for them

Sovaldi is also approved for use in children ages 3 years and older with HCV type 2 or 3. It can be used to treat these types of HCV in children who either have never been treated for HCV or have tried other treatments in the past that didn't work for them.

For children, Sovaldi should be used in combination with ribavirin.

For both adults and children, Sovaldi can be prescribed for people without cirrhosis (liver scarring) or with compensated (mild) cirrhosis.

Effectiveness of Sovaldi for hepatitis C

Clinical trials have shown that Sovaldi was effective in successfully treating HCV. Successful treatment of HCV meant that the virus was no longer found people's blood 12 weeks after they'd completed treatment.

The studies described below weren't placebo-controlled. This means that there weren't any people in the studies who didn't take active medications for their HCV. All of the people in the studies received Sovaldi in combination with other medications.

Effectiveness for HCV types 1 and 4

In clinical trials of people with type 1 HCV who had never been treated for HCV before, 90% were successfully treated after taking Sovaldi for 12 weeks. About 96% of people with type 4 HCV who hadn't been treated in the past had successful treatment after 12 weeks of using Sovaldi. All of these people took Sovaldi in combination with ribavirin and pegylated interferon.

Effectiveness for HCV type 2

Sovaldi was also studied in people with type 2 HCV. Some of the people had never been treated before for HCV, while other people had tried treatments in the past that weren't successful for them. All of the people took Sovaldi in combination with ribavirin for 12 weeks. In this study, 93% of the people were successfully treated for HCV.

Effectiveness for HCV type 3

Sovaldi was also studied in people with type 3 HCV. Some of the people had never been treated before for HCV, while other people had tried treatments in the past that weren't successful for them. These people took Sovaldi in combination with ribavirin for 24 weeks. In this study, 84% of the people were successfully treated for HCV.

Sovaldi and children

Sovaldi is FDA-approved for use in children ages 3 years and older with chronic (long-lasting) HCV. However, it's only approved for use in children who have HCV type 2 or 3.

For children, Sovaldi should be used in combination with ribavirin. Sovaldi can be prescribed for children without cirrhosis (liver scarring) or those with compensated (mild) cirrhosis.

Effectiveness for HCV in children

Clinical trials included children ages 3 years and older who had HCV types 2 or 3. Children with HCV type 2 were treated for 12 weeks, while children with HCV type 3 were treated for 24 weeks. All of the children took ribavirin with Sovaldi. These studies did not include comparison groups of children who didn't receive HCV treatment.

In these clinical trials, most of the children were successfully treated 12 weeks after completing Sovaldi treatment. Successful treatment means that 12 weeks after they'd completed treatment, the children had no HCV found in their blood on lab tests.

For children with HCV type 2, Sovaldi and ribavirin treatment was successful for:

  • 100% of children ages 12 years to 18 years
  • 100% of children ages 6 years to 12 years
  • 80% of children ages 3 years to 6 years

For children with HCV type 3, Sovaldi and ribavirin treatment was successful for:

  • 97% of children ages 12 years to 18 years
  • 100% of children ages 6 years to 12 years
  • 100% of children ages 3 years to 6 years

Sovaldi is used in combination with other drugs to treat hepatitis C virus (HCV). Depending on which type of HCV you have, you'll either take Sovaldi in combination with ribavirin and pegylated interferon, or you'll take Sovaldi with just ribavirin.

Sovaldi with ribavirin

Ribavirin (Rebetol) is an antiviral drug that's used in combination with Sovaldi to treat chronic HCV.

Ribavirin has boxed warnings, which are the most serious warnings given by the Food and Drug Administration (FDA). These warnings alert doctors and patients to very serious side effects that a drug can cause. Ribavirin has the following boxed warnings:

  • Anemia (low red blood cell level). Ribavirin can cause anemia. This condition may worsen heart disease if you already have heart problems. In some cases, this can lead to heart attack or death. If you have a history of serious or unstable heart disease, you should not take ribavirin.
  • Birth defects or death of a developing fetus. Ribavirin should never be used by pregnant women or their male sexual partners. This drug can cause birth defects or even pregnancy loss if a developing fetus is exposed to it. During treatment with ribavirin, birth control should be used by females who are able to become pregnant and by males with female partners who may become pregnant. Pregnancy should be avoided during treatment and for at least 6 months after taking the last dose of ribavirin.
  • Must be used in combination with other treatments. Ribavirin shouldn't be taken on its own to treat HCV. It hasn't been found to be effective to treat HCV unless it's used in combination with other drugs for this condition.

Ribavirin may also cause other serious side effects, including:

  • pancreatitis
  • blood disorders
  • severe allergic reaction
  • lung problems, such as pneumonia
  • decreased growth in children

If you need to take ribavirin, talk with your doctor about the risks and benefits of using this drug.

Sovaldi with pegylated interferon

Pegylated interferon (Pegasys) is an antiviral drug that may be used in combination with both Sovaldi and ribavirin in people with HCV type 1 or 4.

Pegylated interferon also has a boxed warning, which is the most serious warning given by the FDA. Boxed warnings alert doctors and patients to very serious side effects that a drug can cause. Pegylated interferon has a boxed warning for the following side effects:

If you need to take pegylated interferon, talk with your doctor about the risks and benefits of using this drug.

Sovaldi with other drugs

Sovaldi contains the drug sofosbuvir. This drug is used with other antiviral drugs in certain combination medications for treating HCV. Examples of combination medications that contain sofosbuvir include:

  • ledipasvir/sofosbuvir (Harvoni)
  • sofosbuvir/velpatasvir (Epclusa)
  • velpatasvir/sofosbuvir/voxilaprevir (Vosevi)

If you'd like to know more about combination medications to treat your HCV, talk with your doctor. They can discuss all of your treatment options with you.

Sovaldi doesn't interact with alcohol. However, you shouldn't drink alcohol if you have HCV. This is because drinking alcohol can worsen the condition of your liver and possibly make you feel sicker.

In fact, some insurance companies may not pay for Sovaldi, unless you're not currently using any illegal drugs or drinking alcohol.

If you drink alcohol, talk with your doctor about how to stop drinking before you start taking Sovaldi.

Sovaldi 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.

Sovaldi and other medications

Below are lists of medications that can interact with Sovaldi. These lists do not contain all the drugs that may interact with Sovaldi.

Before taking Sovaldi, 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 can help you avoid potential interactions.

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

Sovaldi and amiodarone

You should not take a certain heart medication called amiodarone (Pacerone, Nexterone) while you're taking Sovaldi. Taking these medications together may cause your heart rate to become too slow. Sometimes this drop in heart rate can be very dangerous and cause you to faint. It's not known why this side effect happens when you take amiodarone and Sovaldi together.

In some rare cases, your doctor may recommend that you take amiodarone and Sovaldi together. This would usually only be done if there's no better option to treat either your heart condition or your hepatitis C infection.

If you're taking both amiodarone and Sovaldi, your heart will be monitored in a hospital or doctor's office for the first 48 hours after you've started taking the medications together. After that, you'll need to check your heart rate at least once each day for at least the first 2 weeks of treatment.

If you're taking these medications together and you start to have symptoms such as dizziness, weakness, trouble breathing, or feeling faint, call your doctor right away. They can recommend whether you need medical care.

Sovaldi and certain antibiotics

You should not take certain antibiotics while you're taking Sovaldi. Examples of antibiotics that should be avoided include:

  • rifampin (Rifadin)
  • rifabutin (Mycobutin)
  • rifapentine (Priftin)

These antibiotics may cause the level of Sovaldi in your body to decrease. This means that Sovaldi may not work as well to treat your hepatitis C infection. In some cases, Sovaldi might not be able to work at all.

If you need to take any antibiotics while you're using Sovaldi, talk with your doctor. They can recommend whether it's safe for you to take the medications together.

Sovaldi and warfarin

Taking warfarin (Coumadin, Jantoven) in combination with Sovaldi may cause your warfarin level to get either too high or too low. In some cases, this can be dangerous. If your warfarin level gets too high, you can bleed very easily. However, if your warfarin level gets too low, the drug may not work to properly thin your blood. In this case, you may develop blood clots.

If you're taking Sovaldi and warfarin together, it's important that you get the thickness of your blood checked frequently. Your doctor will recommend how often you'll need to have your blood tested. Your doctor may need to adjust your dosage of warfarin if you're taking it with Sovaldi. This will help your doctor to be sure that your warfarin levels are safe.

Sovaldi and certain seizure medications

It's recommended that you don't take certain seizure medications with Sovaldi. Some seizure medications can cause the level of Sovaldi in your body to decrease. This means that Sovaldi may not be able to work as well to treat your hepatitis C infection.

Examples of seizure medications that should be avoided while you're taking Sovaldi include:

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

If you need to take a seizure medication while you're using Sovaldi, talk with your doctor. They can recommend whether it's safe for you to take the medications together.

Sovaldi and tipranavir

The antiviral drug tipranavir (Aptivus), which is used to treat HIV, should not be taken with Sovaldi. (Note: tipranavir is always used in combination with another antiviral called ritonavir.)

Taking tipranavir with Sovaldi may lower the level of Sovaldi in your body. This means Sovaldi may not work as well to treat your hepatitis C infection.

If you need to take any antiviral medications while you're using Sovaldi, talk with your doctor. They can recommend whether it's safe for you to take the medications together.

Sovaldi and herbs and supplements

Sovaldi may interact with certain herb and supplements. One example is the herbal supplement St. John's wort, which is described below.

Sovaldi and St. John's wort

You shouldn't take St. John's wort while you're taking Sovaldi. This is because St. John's wort may interact with Sovaldi and decrease the level of Sovaldi in your body. If this happens, Sovaldi may not be able to work as well to treat your hepatitis C infection.

You should always check with your doctor or pharmacist before using any herbs or supplements while you're taking Sovaldi.

How long your doctor prescribes you to take Sovaldi will depend on several factors. These include:

  • the type and severity of your hepatitis C virus (HCV)
  • your age
  • your weight
  • if you've had other treatments for HCV in the past

Your doctor will ultimately prescribe the smallest dosage that provides the desired effect.

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

Sovaldi comes as 200-mg and 400-mg tablets. It's also available as pellets, which can be sprinkled on food and taken by mouth. The pellets, which come in single-dose packets, are available in two strengths: 150 mg and 200 mg.

Dosage for chronic hepatitis C

The typical dosage of Sovaldi in adults is one 400-mg tablet taken by mouth once daily. It can be taken with or without food.

Your doctor will prescribe Sovaldi to be taken in combination with either ribavirin alone or ribavirin and pegylated interferon. The combination of medications that you're given depends on the type of HCV that you have. The length of time that you'll take Sovaldi also depends on which type of HCV you have, as well as if you've ever been treated for HCV before.

The recommended length of Sovaldi treatment and combination of medications used are as follows:

  • If you have type 1 or type 4 HCV and you've never been treated for HCV before, you'll take Sovaldi in combination with ribavirin and pegylated interferon alfa for 12 weeks.
  • If you have type 2 HCV, and you've either never been treated for HCV before or past treatments weren't successful, you'll take Sovaldi and ribavirin for 12 weeks.
  • If you have type 3 HCV, and you've either never been treated for HCV before or past treatments weren't successful, you'll take Sovaldi and ribavirin for 24 weeks.

In some cases, your doctor may recommend a different treatment length than what is described here. This may happen if you aren't able to take pegylated interferon, or if you have liver cancer or HIV.

Pediatric dosage

The typical dosage of Sovaldi in children ages 3 years and older is based on the child's weight. For children, Sovaldi is prescribed in combination with ribavirin.

The typical dosage of Sovaldi in children is as follows:

  • For children who weigh 35 kilograms (about 77 pounds) or more, the typical dosage is one 400-mg tablet taken by mouth once each day.
  • For children who weigh 17 kilograms (about 37 pounds) to less than 35 kilograms (about 77 pounds), the typical dosage is 200 mg each day.
  • For children who weigh less than 17 kilograms (about 37 pounds), the typical dosage is 150 mg each day.

Children who have trouble swallowing tablets can take Sovaldi pellets. The pellets, which come in single-dose packets, can be sprinkled onto food and taken by mouth.

The length of time that Sovaldi will need to be taken depends on which type of HCV a child has. The recommended treatment length is as follows:

  • For children with type 2 HCV, Sovaldi and ribavirin should be taken for 12 weeks.
  • For children with type 3 HCV, Sovaldi and ribavirin should be taken for 24 weeks.

What if I miss a dose?

If you miss a dose of Sovaldi, and it's the same day as you should have taken it, take the missed dose as soon as you remember. However, if you missed Sovaldi for a whole day, just take your next scheduled dose. Never take more than one dose of Sovaldi in the same day.

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

Will I need to use this drug long term?

No, not usually. Sovaldi is used to treat infections caused by hepatitis C virus (HCV). Usually, the drug is only taken for 12 weeks to 24 weeks. But for some people, such as those waiting for a liver transplant, Sovaldi may be continued for up to 48 weeks.

Talk with your doctor about how long you should use Sovaldi. They can recommend the best treatment plan based on your unique needs.

Sticking to your Sovaldi treatment plan

Taking your Sovaldi tablets exactly as your doctor prescribes is very important. This is because correctly following your treatment plan increases the chances that your hepatitis C infection will be successfully treated. Following your treatment plan also helps reduce your risk of long-term effects of HCV, such as cirrhosis (liver scarring) and liver cancer.

Missing doses of Sovaldi can make the drug less effective to treat HCV. In some cases, if you miss enough doses, your HCV may not be successfully treated.

Be sure to follow your doctor's instructions and take one Sovaldi tablet once each day. Using a reminder tool can be helpful in making sure you take Sovaldi every day.

If you have any questions about your treatment plan, talk with your doctor. They can help answer your questions and recommend ways to help you keep on track with your treatment.

Sovaldi is used to treat chronic (long-lasting) hepatitis C virus (HCV). This drug works by stopping the virus from multiplying (making more virus) and infecting more cells in your body.

Sovaldi belongs to a class of drugs called direct-acting antiviral medications. This means that it works directly on the hepatitis virus to stop it from multiplying. Once the virus can no longer multiply, it dies and your body can clear the infection.

How long does it take to work?

Sovaldi will start working right away in your body after you take it. You may even begin to feel fewer hepatitis symptoms after only days or weeks after starting the medication.

However, it's important to take Sovaldi for the entire length of time that the doctor recommends, even if you start feeling better sooner. Depending on which type of hepatitis C you have, it usually takes 12 or 24 weeks for Sovaldi to successfully treat the virus.

You should take Sovaldi according to your doctor's or healthcare provider's instructions.

When to take

Sovaldi should be taken by mouth once every day. It can be taken at any time of day, but it should be taken at about the same time each day. For example, if you take your first dose at 9 a.m., you should try to continue taking the drug at 9 a.m. for each of your following doses. This will help keep the level of Sovaldi in your body consistent each day.

Taking the medication on a regular schedule will also help you to remember to take it each day.

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

Taking Sovaldi with food

Sovaldi can be taken with or without food. Sometimes nausea can be a side effect of Sovaldi. If you have nausea during treatment, you may want to try taking Sovaldi with food. This may help reduce your nausea and help you feel better.

Can Sovaldi be crushed, split, or chewed?

The makers of Sovaldi haven't stated whether Sovaldi is effective if the tablets are crushed, split, or chewed. If you have questions about crushing, splitting, or chewing this medication, talk with your doctor or pharmacist.

Sovaldi is also available as pellets that can be sprinkled on food. If you're concerned about swallowing the Sovaldi tablets, the pellets may be an option for you.

As with all medications, the cost of Sovaldi can vary. To find current prices for Sovaldi in your area, check out GoodRx.com.

The cost you find on GoodRx.com is what you may pay without insurance. The actual price you'll pay depends on your insurance plan, your location, and the pharmacy you use.

Your insurance plan may require you to get prior authorization before approving coverage for Sovaldi. This means that your doctor will need to send a request to your insurance company asking them to cover the drug. The insurance company will review the request and let you and your doctor know if your plan will cover Sovaldi.

If you're not sure if you'll need to get prior authorization for Sovaldi, contact your insurance company.

Financial and insurance assistance

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

Gilead Sciences, Inc., the manufacturer of Sovaldi, offers a copay coupon that may help lower the cost of the drug. For more information and to find out if you're eligible for support, call 855-769-7284 or visit the program website.

There haven't been any studies in pregnant women to know whether Sovaldi is safe to take during pregnancy. Animal studies have shown no effects on developing fetuses when pregnant females were given Sovaldi. But keep in mind that animal studies don't always predict what will happen in people.

It's also important to remember that Sovaldi is used as part of a treatment plan that includes ribavirin. In humans, ribavirin can cause birth defects or even fetal death if it's used during pregnancy.

Treatment guidelines recommend that pregnant women who are diagnosed with HCV wait to treat the infection until they're no longer pregnant. This helps to reduce the risks of treatment for their unborn child.

Sovaldi and ribavirin in pregnancy

Pregnancy should be avoided by both females and males during ribavirin treatment and for at least 6 months after finishing treatment. For more information on birth control recommendations, see the section "Sovaldi and birth control" below.

Also, before starting treatment with ribavirin, women will need to have a negative pregnancy test. Women should continue to be tested for pregnancy each month during treatment, and each month for 6 months after their last dose of ribavirin.

If you or your partner becomes pregnant during ribavirin treatment, call your doctor right away. Pregnant females are encouraged to enroll in the ribavirin pregnancy registry. This registry monitors side effects and collects information from people who are taking ribavirin during pregnancy. This information helps doctors and other pregnant women know about the safety of using this drug during pregnancy. You can sign up for the registry by calling 800-593-2214.

It's not known if Sovaldi is safe to take during pregnancy. However, ribavirin, which is taken in combination with Sovaldi, is not safe to take 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 being treated for hepatitis C.

If you're taking Sovaldi in combination with ribavirin for hepatitis C, pregnancy should be avoided during treatment.

Birth control for women using Sovaldi with ribavirin

If you're a female who's able to become pregnant, you'll need to take a pregnancy test before starting ribavirin. By doing this, your doctor will make sure that you aren't pregnant when you start using the drug. You'll continue to take a pregnancy test every month while you're taking ribavirin. You'll also continue to have pregnancy tests each month for the 6 months following your treatment.

While you're using ribavirin, you should use an effective form of birth control to prevent pregnancy during treatment. And you should continue to use birth control for at least 6 months after you finish ribavirin treatment.

If you have questions about which method of birth control is best for you, talk with your doctor.

Birth control for men using Sovaldi with ribavirin

If you're a male with a female partner who's able to become pregnant, you'll need to use an effective form of birth control during ribavirin treatment. And you should continue to use birth control for at least 6 months after you finish ribavirin treatment.

If you have questions about which method of birth control is best for you, talk with your doctor.

It's not known if Sovaldi is safe to use while breastfeeding. Animal studies have shown no effects on the growth or development of offspring who were breastfed by lactating females given the drug. However, animal studies don't always predict what will happen in humans.

If you have questions about breastfeeding while taking Sovaldi, talk with your doctor. They can recommend safe and healthy ways to feed your child.

Here are answers to some frequently asked questions about Sovaldi.

Can I use Sovaldi if I've used other hepatitis C treatments in the past?

Yes, you may be able to. Sovaldi is approved for use in people with hepatitis C virus (HCV) type 2 or 3 who've used other treatments in the past. However, Sovaldi isn't approved for people with HCV type 1 or 4 who've been treated in the past. (But some people have used Sovaldi off-label for this purpose. Off-label use is when a drug is approved to treat one condition, but it's used for a different one.)

This difference in uses may be because different types of HCV can be more or less resistant to Sovaldi. If certain types are resistant to Sovaldi, the medication may not work as well to treat them successfully.

However, certain other medications that contain sofosbuvir (the active drug in Sovaldi) may be used in anyone who has HCV, even if the HCV has been treated in the past. One example of this type of medication is the combination drug called Epclusa (velpatasvir/sofosbuvir).

If you have questions about which HCV medications are right for you, talk with your doctor.

If I have HIV, can I take Sovaldi?

Yes, if you have HIV, you may still be able to take Sovaldi if your doctor recommends it. Sovaldi has been tested in people with both HIV and HCV. In these studies, the drug was shown to be safe and effective for treating HCV.

However, Sovaldi should not be taken along with the HIV medication called tipranavir (Aptivus). (Note: tipranavir is always used in combination with a drug called ritonavir.) Taking Sovaldi with tipranavir can reduce the level of Sovaldi in your body. This might make Sovaldi less effective to treat your HCV infection.

If you're taking any HIV medications, talk with your doctor before starting Sovaldi. They can make sure it's safe for you to use Sovaldi.

Can I take Sovaldi if I've had a liver transplant?

It's not known if Sovaldi is safe and effective to treat HCV in people who've had a liver transplant. Sometimes if your HCV is diagnosed early enough and you're started on Sovaldi, treatment with the drug can prevent you from needing a liver transplant.

However, if you've had a liver transplant or you currently need one, your doctor may recommend medications other than Sovaldi to treat your HCV.

Can I transmit hepatitis C to another person while I'm receiving treatment with Sovaldi?

Yes, it's possible to transmit HCV to someone else while you're being treated for the virus. This is because HCV is still present in your blood during treatment. If your blood or other bodily fluids come into contact with someone else, that person may become infected with the virus.

After completing treatment with Sovaldi, your doctor will check your blood for HCV. If you've cleared the virus and it's no longer found in your blood, it's much less likely that you'll pass HCV to other people.

If you'd like to know more about how you can prevent passing HCV to other people, talk with your doctor.

Is Daklinza or Olysio ever used with Sovaldi?

Like Sovaldi, Daklinza (daclatasvir) and Olysio (simeprevir) also treat hepatitis C virus (HCV).

For some people, these medications can be used in combination with Sovaldi to treat HCV. This is because Daklinza and Olysio work in different ways than Sovaldi does to target the virus inside your body.

Your treatment plan will depend on many factors including what type of HCV you have, if you've used other HCV treatments in the past, and the condition of your liver. If you have questions about which HCV medications are best for you, talk with your doctor.

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 healthcare providers and patients about drug effects that may be dangerous.

Reactivation of hepatitis B virus (HBV) is possible in people who have both HBV and hepatitis C virus (HCV). HBV reactivation is a flare-up of the virus, if it's already inside your body. This can occur while you're taking Sovaldi or even after you've finished Sovaldi treatment. Sometimes hepatitis B infections can lead to severe liver failure or even death.

Before you start taking Sovaldi, your doctor will order blood tests to see if you have HBV. If you have both HBV and HCV, your doctor may order extra blood tests to monitor your liver function while you're taking Sovaldi. Your doctor may also treat your HBV before you start taking Sovaldi or while you're taking Sovaldi.

Other precautions

Before taking Sovaldi, talk with your doctor about your health history. Sovaldi may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

  • Decreased heart rate and blood pressure. Taking Sovaldi along with amiodarone (Pacerone) may cause a large decrease in your heart rate that can be very serious. This may lead to dizziness, weakness, or fainting. If you're also taking a beta-blocker medication, such as metoprolol (Lopressor, Toprol XL), your blood pressure may also be decreased. If you have heart disease or advanced liver disease, your blood pressure may decrease drastically. It's not recommended that you take amiodarone with Sovaldi. If you have heart disease or advanced liver disease, are taking a beta-blocker, or must take Sovaldi and amiodarone together, your doctor will monitor your heart closely. This allows your doctor to watch for changes in your heart rate and blood pressure.
  • Liver transplant. It's not known if Sovaldi is safe and effective to treat hepatitis C in people who've had a liver transplant. If you have a history of liver transplant, talk to your doctor before starting this medication.
  • Pregnancy. It's not known if Sovaldi is safe to take during pregnancy. However, ribavirin, one of the medications that's used in combination with Sovaldi, is not safe to use during pregnancy. If used during pregnancy, this medication can cause birth defects or even death to a developing fetus. Talk with your doctor about your birth control needs before starting Sovaldi and ribavirin. For more information, please see the "Sovaldi and pregnancy" and "Sovaldi and birth control" sections above.
  • Breastfeeding. It's not known if Sovaldi is safe to take while breastfeeding. If you're breastfeeding, talk with your doctor before taking Sovaldi. For more information, please see the "Sovaldi and breastfeeding" section above.

Note: For more information about the potential negative effects of Sovaldi, see the "Sovaldi side effects" section above.

Using more than the recommended dosage of Sovaldi can lead to serious side effects. You should never take more than one tablet of Sovaldi within the same day.

Overdose symptoms

It's not known what symptoms may occur if you take too much Sovaldi. In clinical trials, some people took 1,200 mg of Sovaldi, which is three times the approved daily dose (400 mg daily). These people reported similar side effects as those reported both by people taking the approved dose of Sovaldi and by people taking a placebo (no active drug).

What to do in case of overdose

If you think you've taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use their online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.

When you get Sovaldi from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically 1 year from the date they dispensed the medication.

The expiration date helps guarantee that the medication is effective during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk to your pharmacist about whether you might still be able to use it.

Do not use Sovaldi if the seal on the bottle is broken or missing when you pick it up from your pharmacy.

Storage

How long a medication remains good can depend on many factors, including how and where you store the medication.

Sovaldi tablets or pellets should be stored at room temperature, but below 86°F (30°C). This medication should be kept in its original container, tightly sealed, and away from light. Avoid storing this medication in areas where it could get damp or wet, such as in bathrooms.

Disposal

If you no longer need to take Sovaldi and have leftover medication, it's important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.

The FDA website provides several useful tips on medication disposal. You can also ask your pharmacist for information on how to dispose of your medication.

The following information is provided for clinicians and other healthcare professionals.

Indications

Sovaldi is indicated for use in adults without cirrhosis or with compensated cirrhosis, and with the following types of hepatitis C virus (HCV):

  • type 1 or 4, to be used in combination with ribavirin and pegylated interferon
  • type 2 or 3, to be used in combination with ribavirin

Sovaldi is also indicated for use in children ages 3 years and older, without cirrhosis or with compensated cirrhosis, and with HCV type 2 or 3. For children, Sovaldi should be used in combination with ribavirin.

Sovaldi can be used to treat HCV types 1, 2, 3, and 4 in adults who have not yet received HCV treatment. The drug can also be used to treat HCV types 2 and 3 in adults and children who have received prior HCV treatment.

Mechanism of action

Sovaldi is a direct-acting antiviral agent. It works by inhibiting an RNA-dependent RNA polymerase (called HCV NS5B) that is specific to the hepatitis C virus. Inhibiting this enzyme blocks replication of HCV, which eventually leads to elimination of the virus.

Sofosbuvir, the active ingredient in Sovaldi, is a prodrug that is metabolized to its active form, uridine analog triphosphate (GS-461203). This active form is used in the viral RNA production and causes chain termination. However, human DNA polymerase, human RNA polymerase, and mitochondrial RNA polymerase are not affected by Sovaldi.

Pharmacokinetics and metabolism

In clinical trials, peak plasma concentration occurred about 30 minutes to 2 hours after Sovaldi was taken. It is approximately 61% to 65% plasma protein bound.

Sovaldi is metabolized by the liver to form the active triphosphate GS-461203. This occurs by hydrolysis of a carboxyl ester and then cleavage by histidine triad nucleotide-binding protein 1 (HINT1). GS-461203 can then be dephosphorylated into GS-331007, which does not work against HCV in vitro.

Sovaldi is eliminated extensively by the kidneys, with 80% of the drug excreted in the urine. The remainder is excreted via feces or expired air.

The half-life of Sovaldi (parent drug) is 0.4 hours, whereas the half-life of GS-331007 is 27 hours.

Contraindications

There are no contraindications specific to Sovaldi. However, Sovaldi is indicated for use along with either ribavirin alone or ribavirin and pegylated interferons, which each have contraindications. These contraindications are listed below.

The following are contraindications to use of ribavirin:

  • current pregnancy, in women using the drug
  • having a female sexual partner who is pregnant, for men using the drug
  • history of allergic reaction to ribavirin
  • autoimmune hepatitis
  • hemoglobinopathies
  • use in combination with didanosine
  • creatinine clearance less than 50 mL/min

The following are contraindications to use of pegylated interferons:

  • autoimmune hepatitis
  • liver decompensation in people with cirrhosis
  • neonates or infants
  • history of allergic reaction to pegylated interferons

Storage

Sovaldi should be stored at room temperature, below 86°F (30°C). It should be kept in its original container. Sovaldi should not be used if the seal on the bottle is missing or has already been broken. Sovaldi should be kept out of children's reach. Avoid storing it in bathrooms or other places where the medication could get wet or be exposed to temperatures greater than 86°F (30°C).

Disclaimer: Medical News Today 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 other 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.