Frequently Asked Questions

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Understanding hepatitis C

What is hepatitis C (Hep C) and what are its effects?

Hep C is a virus that spreads from person to person through blood and infects the liver. Chronic (or long-lasting) Hep C is a viral infection of the liver that progresses slowly. Over time it can cause liver damage or liver failure. Hep C infection now kills more Americans every year than HIV.

If you have Hep C, you should work with your healthcare provider to monitor your liver damage and discuss your treatment options before it progresses.

What is a genotype and why is this important?

Just as there are different blood types, there are also different types of Hep C, called genotypes. There are 6 main genotypes. SOVALDI has been shown to work in genotypes 1, 2, 3, and 4. SOVALDI combination therapy is the first all-oral treatment for genotypes 2 and 3. It is important to know your genotype because it can help your healthcare provider choose the right treatment for you. It can also affect the length of your treatment and your chance of being cured. Your healthcare provider can do a simple blood test to determine which type of Hep C you have.

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About SOVALDI

What is SOVALDI?

SOVALDI is a prescription medicine used with other antiviral medicines to treat chronic (lasting a long time) hepatitis C genotype 1, 2, 3, or 4 infection in adults.

It is not known if SOVALDI is safe and effective in children under 18 years of age.

What is sofosbuvir?

Sofosbuvir (brand name SOVALDI) is a breakthrough medicine that works directly against the Hep C virus to keep it from multiplying inside the body.

How long does combination therapy with SOVALDI last?

For most people, treatment will last for 12 weeks. For those with genotype 3, treatment will last for 24 weeks. Results are measured 3 months after treatment is completed.

How do I take SOVALDI?
  • Take 1 tablet of SOVALDI 1 time each day only, with or without food.
  • Take SOVALDI exactly as your healthcare provider tells you to take it. Do not change your dose unless your healthcare provider tells you to.
  • Do not stop taking SOVALDI without first talking with your healthcare provider. If you think there is a reason to stop taking SOVALDI, talk to your healthcare provider before doing so.
  • If you miss a dose of SOVALDI, take the missed dose as soon as you remember the same day. Do not take more than 1 tablet (400 mg) of SOVALDI in a day. Take your next dose of SOVALDI at your regular time the next day.
  • If you take too much SOVALDI, call your healthcare provider or go to the nearest hospital emergency room right away.
What should I tell my healthcare provider before taking SOVALDI?

Before taking SOVALDI, tell your healthcare provider if you:

  • have liver problems other than hepatitis C infection
  • have had a liver transplant
  • have severe kidney problems or you are on dialysis
  • have HIV
  • have any other medical condition
  • are pregnant or plan to become pregnant. When taking SOVALDI in combination with ribavirin, you should also read the ribavirin Medication Guide for important pregnancy information.
  • are breastfeeding or plan to breastfeed. It is not known if SOVALDI passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take SOVALDI.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Other medicines may affect how SOVALDI works.

You should not take SOVALDI if you also take other medicines that contain sofosbuvir (Harvoni®).

Especially tell your healthcare provider if you take any of the following medicines:

  • amiodarone (Cordarone®, Nexterone®, Pacerone®)
  • carbamazepine (Carbatrol®, Epitol®, Equetro®, Tegretol®)
  • oxcarbazepine (Trileptal®, Oxtellar XR®)
  • phenytoin (Dilantin®, Phenytek®)
  • phenobarbital (Luminal®)
  • rifabutin (Mycobutin®)
  • rifampin (Rifadin®, Rifamate®, Rifater®, Rimactane®)
  • rifapentine (Priftin®)
  • St. John’s wort (Hypericum perforatum) or a product that contains St. John’s wort
  • tipranavir (Aptivus®)

Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

After I have finished treatment, how long will it take for me to find out if I am cured?

Cure means the Hep C virus is not detected in the blood when measured with a blood test by your healthcare provider 3 months after treatment is completed.

Use the treatment timeline to find the first date you can schedule a blood test to determine your results.

What are the most common side effects of SOVALDI?

The most common side effects of SOVALDI when used in combination with ribavirin include:

  • tiredness
  • headache

The most common side effects of SOVALDI when used in combination with peginterferon alfa and ribavirin include:

  • tiredness
  • headache
  • nausea
  • difficulty sleeping
  • low red blood cell count

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of SOVALDI. For more information, ask your healthcare professional or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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How does SOVALDI work?

Can I take SOVALDI if I was not cured with a previous Hep C treatment?

Patients who have not been cured with previous interferon-based treatments can take SOVALDI combination regimens. Cure means the Hep C virus is not detected in the blood when measured 3 months after treatment is completed.

Talk with your healthcare provider to find out if treatment with SOVALDI may be right for you.

Can I take SOVALDI if I am unable to take interferon treatment?

SOVALDI in combination with ribavirin for 24 weeks can be considered for Hep C patients with GT1 infection who are interferon ineligible. SOVALDI combination therapy for Hep C patients with GT2 and GT3 infection does not include interferon.

Talk with your healthcare provider to find out if treatment with SOVALDI may be right for you.

Can I take SOVALDI if I have cirrhosis?

For some, SOVALDI combination therapy can cure chronic Hep C even if you have cirrhosis.

Talk with your healthcare provider to find out if treatment with SOVALDI may be right for you.

Can I take SOVALDI if I have liver cancer and am awaiting a liver transplant?

Certain patients with chronic Hep C who have liver cancer and are awaiting a liver transplant can take SOVALDI + ribavirin for up to 48 weeks or until the time of liver transplantation. This is to prevent reinfection with Hep C after transplant.

Talk with your healthcare provider to find out if treatment with SOVALDI may be right for you.

Will SOVALDI affect me differently because I am black?

In a clinical study, race had no effect on the efficacy of the SOVALDI treatment regimen.

Talk with your healthcare provider to find out if treatment with SOVALDI may be right for you.

Can I take SOVALDI if I have Hep C and am also infected with HIV?

The SOVALDI dosing and treatment regimens for people co-infected with Hep C and HIV are the same as SOVALDI dosing and treatment regimens for people with Hep C who don’t have HIV.

Talk with your healthcare provider to find out if treatment with SOVALDI may be right for you.

SOVALDI is a prescription medicine used with other antiviral medicines to treat chronic (lasting a long time) hepatitis C genotype 1, 2, 3, or 4 infection in adults. It is not known if SOVALDI is safe and effective in children under 18 years of age.

Important Safety Information

What should I tell my healthcare provider before taking SOVALDI?

  • If you have: liver problems other than hepatitis C infection; had a liver transplant; severe kidney problems or are on dialysis; HIV; any other medical condition; are pregnant or plan to become pregnant; or if you are breastfeeding or plan to breastfeed. It is not known if SOVALDI passes into your breast milk.
  • If you take amiodarone (Cordarone®, Nexterone®, Pacerone®), rifampin (Rifadin®, Rifamate®, Rifater®), St. John’s wort or a product that contains St. John’s wort. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Other medicines may affect how SOVALDI works.

You should not take SOVALDI if you also take other medicines that contain sofosbuvir (HARVONI®).

What are the most common side effects of SOVALDI?
For SOVALDI used in combination with ribavirin they include tiredness and headache and for SOVALDI used in combination with peginterferon alfa and ribavirin they include the additional side effects of nausea, difficulty sleeping, and low red blood cell count.

SOVALDI, the SOVALDI logo, HARVONI, ONWARD, the ONWARD logo, SUPPORT PATH, the SUPPORT PATH logo, GILEAD, and the GILEAD logo are trademarks of Gilead Sciences, Inc., or its related companies. All other trademarks referenced herein are the property of their respective owners.
©2016 Gilead Sciences, Inc. All rights reserved. SVDC0302 12/16

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SOVALDI is a prescription medicine used with other antiviral medicines to treat chronic (lasting a long time) hepatitis C genotype 1, 2, 3, or 4 infection in adults. It is not known if SOVALDI is safe and effective in children under 18 years of age.

Important Safety Information

What should I tell my healthcare provider before taking SOVALDI?

  • If you have: liver problems other than hepatitis C infection; had a liver transplant; severe kidney problems or are on dialysis; HIV; any other medical condition; are pregnant or plan to become pregnant; or if you are breastfeeding or plan to breastfeed. It is not known if SOVALDI passes into your breast milk.
  • If you take amiodarone (Cordarone®, Nexterone®, Pacerone®), rifampin (Rifadin®, Rifamate®, Rifater®), St. John’s wort or a product that contains St. John’s wort. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Other medicines may affect how SOVALDI works.

You should not take SOVALDI if you also take other medicines that contain sofosbuvir (HARVONI®).

What are the most common side effects of SOVALDI?
For SOVALDI used in combination with ribavirin they include tiredness and headache and for SOVALDI used in combination with peginterferon alfa and ribavirin they include the additional side effects of nausea, difficulty sleeping, and low red blood cell count.