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Sovaldi

Generic Name: sofosbuvir (soe FOS bue vir)
Brand Names: Sovaldi

Medically reviewed on February 6, 2018

What is Sovaldi?

Sovaldi (sofosbuvir) is an antiviral medication that prevents hepatitis C virus (HCV) from multiplying in your body.

Sovaldi is used in combination with other medications to treat chronic hepatitis C in adults and children who are at least 12 years old or who weigh at least 77 pounds (35 kilograms).

Sovaldi treats specific genotypes of hepatitis C, and only in certain people. Use only the medications prescribed for you. Do not share your medicine with other people.

Sovaldi must be given in combination with other antiviral medications and should not be used alone. Sofosbuvir is usually given with ribavirin, with or without peginterferon alfa.

Sovaldi is sometimes used in people who also have HIV, or people who have liver cancer and are going to have a liver transplant. This medicine is not a treatment for HIV or AIDS.

Important Information

If you have ever had hepatitis B, Sovaldi can cause this condition to come back or get worse. You will need frequent blood tests to check your liver function.

Sovaldi is used in combination with other medication. Read the medication guide or patient instructions provided with each medication in your combination therapy. Do not change your doses or medication schedule without your doctor's advice.

Ribavirin can cause birth defects or death in an unborn baby. Do not use Sovaldi with ribavirin if you are pregnant, or if you are a man and your female sexual partner is pregnant. Use at least 2 effective forms of non-hormonal birth control while using these medicines together and for at least 6 months after treatment ends.

Before taking this medicine

You should not use Sovaldi if you are allergic to sofosbuvir. If you take Sovaldi with other antiviral medicines: There may be other reasons you should not take this combination treatment. Tell your doctor about all your medical conditions.

To make sure Sovaldi is safe for you, tell your doctor if you have ever had:

Sovaldi is used in combination with ribavirin. Ribavirin can cause birth defects or death in an unborn baby.

  • If you are a woman, do not use ribavirin if you are pregnant. You may need to have a negative pregnancy test before taking ribavirin and every month during your treatment.

  • If you are a man, do not use ribavirin if your sexual partner is pregnant. An unborn baby could be harmed if you have sex with a pregnant woman while you are taking ribavirin.

While taking Sovaldi with ribavirin, use at least 2 effective forms of birth control to prevent pregnancy, whether you are a man or a woman. Ribavirin use by either parent may cause birth defects.

Keep using 2 forms of birth control for at least 6 months after your last dose of ribavirin. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using ribavirin.

It is not known whether sofosbuvir passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

How should I take Sovaldi?

Sovaldi must be given in combination with other antiviral medications and it should not be used alone.

Sovaldi is usually taken with other antiviral medicines once per day for 12 to 24 weeks. Follow all directions on your prescription label. Do not take your medicine in larger or smaller amounts or for longer than recommended.

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using sofosbuvir.

You may take Sovaldi with or without food.

You will need frequent blood tests to check your liver function.

If you have ever had hepatitis B, Sovaldi can cause this condition to come back or get worse. You will need liver function tests during treatment and for several months after you stop using this medicine.

Read the medication guide or patient instructions provided with each medication in your combination therapy. Do not change your doses or medication schedule without your doctor's advice. Every person with chronic hepatitis C should remain under the care of a doctor.

You should not stop using Sovaldi suddenly. Stopping suddenly could make your hepatitis C harder to treat with antiviral medicine.

Store this medicine in the original container at room temperature away from moisture and heat.

Sovaldi dosing information

Usual Adult Dose for Chronic Hepatitis C:

400 mg orally once a day

Recommended Regimen and Duration of Therapy:
-Genotype 1 or 4: Sofosbuvir, peginterferon alfa, and ribavirin for 12 weeks
-Genotype 2: Sofosbuvir and ribavirin for 12 weeks
-Genotype 3: Sofosbuvir and ribavirin for 24 weeks
-Hepatocellular carcinoma awaiting liver transplantation: Sofosbuvir and ribavirin for up to 48 weeks or until liver transplantation (whichever occurs first)

Comments:
-Genotype 1, 4: This regimen is recommended for therapy-naive patients without cirrhosis or with compensated cirrhosis (Child-Pugh A).
-Genotype 2, 3: Both regimens are recommended for therapy-naive and therapy-experienced patients without cirrhosis or with compensated cirrhosis (Child-Pugh A).
-Therapy-experienced patients have failed an interferon-based regimen (with or without ribavirin).
-The dose recommendations for genotype 1, 2, 3, or 4 should be followed for HCV/HIV-1-coinfected patients.
-The manufacturer product information should be consulted for ribavirin dose recommendations; with genotype 1 or 4, the manufacturer product information for peginterferon alfa should also be consulted for dose recommendations.
-Sofosbuvir and ribavirin for 24 weeks can be considered for patients with genotype 1 infection who cannot use an interferon-based regimen; treatment decision should be guided by benefit/risk assessment for the individual patient.
-The regimen for patients with hepatocellular carcinoma awaiting liver transplantation is recommended to prevent posttransplant HCV reinfection.

Use: As a part of a combination antiviral treatment regimen, for the treatment of chronic HCV infection
-In combination with pegylated interferon and ribavirin: For genotype 1 or 4 infection without cirrhosis or with compensated cirrhosis
-In combination with ribavirin: For genotype 2 or 3 infection without cirrhosis or with compensated cirrhosis

Usual Pediatric Dose for Chronic Hepatitis C:

12 years and older or weighing at least 35 kg: 400 mg orally once a day

Recommended Regimen and Duration of Therapy:
-Genotype 2: Sofosbuvir and ribavirin for 12 weeks
-Genotype 3: Sofosbuvir and ribavirin for 24 weeks

Comments:
-Both regimens are recommended for therapy-naive and therapy-experienced patients without cirrhosis or with compensated cirrhosis (Child-Pugh A).
-Therapy-experienced patients have failed an interferon-based regimen (with or without ribavirin).
-The manufacturer product information should be consulted for ribavirin dose recommendations.
-The same dose recommendations should be followed for HCV/HIV-1-coinfected patients.

Use: In combination with ribavirin, for the treatment of chronic HCV genotype 2 or 3 infection in patients without cirrhosis or with compensated cirrhosis

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Use Sovaldi regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Sovaldi?

Taking this medication will not prevent you from passing hepatitis C to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HCV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Sovaldi side effects

Get emergency medical help if you have signs of an allergic reaction to Sovaldi: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have new or worsening symptoms such as:

  • loss of appetite, upper stomach pain;

  • dark urine, clay-colored stools; or

  • jaundice (yellowing of the skin or eyes).

If you take Sovaldi and you also take a heart rhythm medicine called amiodarone: This combination of medicines can cause dangerous side effects on your heart. Get medical help right away if you take these medicines and you have:

  • very slow heartbeats, chest pain, shortness of breath;

  • confusion, memory problems; or

  • weakness, extreme tiredness, light-headed feeling (like you might pass out).

Common Sovaldi side effects may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Sovaldi?

When you start or stop taking Sovaldi, your doctor may need to adjust the doses of any other medicines you take on a regular basis.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may interact with sofosbuvir, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Sovaldi only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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