HARVONI
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Leading the way in Hep C treatment

HARVONI is a prescription medicine used to treat adults with chronic hepatitis C (Hep C) genotype 1, 4, 5, or 6 infection with or without cirrhosis (compensated).

HARVONI transformed Hep C treatment as the first cure with a simple regimen that’s one pill, once a day for the majority of patients. There’s no interferon, no complex regimens.

Now, HARVONI has been prescribed to over a half million people to cure their Hep C.*

In clinical studies, HARVONI was proven to cure 96–99% of adult patients who had Hep C genotype 1 and no prior treatment with 12 weeks of therapy.† Certain patients were cured with just 8 weeks of therapy.‡ Your Hep C Specialist will determine your length of treatment.

If you don’t have Hep C genotype 1, 4, 5, or 6, learn about another treatment option that may be right for you.

Cure means the Hep C virus is not detected in the blood when measured three months after treatment is completed.

*This information is derived from IMS NPA, IMS NSP™, and IntegriChain® data; data reflect estimated patient starts for HARVONI from 10/2014–3/2018.

†In a study of 865 patients with genotype 1 Hep C and no prior Hep C treatment, with or without cirrhosis (compensated), 99% (210 out of 213) of those who received HARVONI once daily for 12 weeks were cured. In a separate study of 647 patients with GT 1 Hep C, with no prior Hep C treatment and without cirrhosis, 96% (208 out of 216) of those who received HARVONI once daily for 12 weeks were cured.

‡In a study of 647 patients with genotype 1 Hep C, with no prior Hep C treatment and without cirrhosis, 97% (119 out of 123) of those with lower levels of the virus (less than 6 million IU/mL) who received HARVONI once daily for 8 weeks were cured.

These studies did not include patients with advanced cirrhosis (decompensated) or those who have had a liver transplant. Advanced cirrhosis (decompensated) is when the liver is extensively scarred and can no longer do its job effectively.

Have you been treated for Hep C before? See clinical study data for Hep C genotype 1 patients with prior Hep C treatment.

See HARVONI clinical study results

HARVONI is a prescription medicine used to treat adults with chronic (lasting a long time) hepatitis C (Hep C) genotype (GT) 1, 4, 5 or 6 infection with or without cirrhosis (compensated). In those with GT 1 and advanced cirrhosis (decompensated) or with GT 1 or 4 with or without cirrhosis (compensated) who have had a liver transplant, HARVONI is used with ribavirin.

Important Safety
Information

What is the most important information I should know about HARVONI?

HARVONI can cause serious side effects, including:

  • Hepatitis B virus reactivation: Before starting HARVONI treatment, your healthcare provider will do blood tests to check for hepatitis B infection. If you have ever had hepatitis B, the hepatitis B virus could become active again during and after treatment with HARVONI. This may cause serious liver problems, including liver failure and death. If you are at risk, your healthcare provider will monitor you during and after taking HARVONI.

Continued below

 
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I didn’t know what hepatitis C was. — Terry C., Fresno, CA
 
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Even though I had no symptoms, it was bad enough knowing that it was in you. — Mitch S., Weimar, CA
 
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I didn’t want to feel like Hep C was hanging over my head all the time. — Carol J., New London, CT
 
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I didn’t know... what to expect. — Bill B., Colorado Springs, CO
 
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I was pretty secretive about the diagnosis early on. — Shayne W., Aliso Viejo, CA
 
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I had no symptoms, I would have never known it. — Rebecca F., Indianapolis, IN
 
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I felt like I was living as if I was an extra in my own movie. — Rob Z., Cleveland, OH

Important Safety
Information

What should I tell my healthcare provider before taking HARVONI?

  • Tell your healthcare provider about all of your medical conditions, including if you have ever had hepatitis B infection, liver problems other than hepatitis C infection, or a liver transplant; if you have kidney problems or are on dialysis; if you have HIV; or if you are pregnant or breastfeeding or plan to become pregnant or breastfeed. It is not known if HARVONI will harm your unborn baby or pass into your breast milk. If you take HARVONI with ribavirin, you should also read the ribavirin Medication Guide for important pregnancy-related information.

Continued below

HARVONI is powered by sofosbuvir

Sofosbuvir is the backbone of HARVONI and was a clear step forward in Hep C treatment.

HARVONI further revolutionized Hep C treatment by combining sofosbuvir and ledipasvir into one pill. It works by targeting certain proteins in the Hep C virus to keep it from reproducing in the body.

Evolution of Hep C Therapy (Select Treatments)

*For the majority of patients

If you don’t have Hep C genotype 1, 4, 5, or 6, learn about another treatment option that may be right for you.

Don’t know your genotype? Read more

Knowing your Hep C genotype is important

Just as there are different blood types, there are also different types of Hep C, called genotypes. The most common type in the U.S. is genotype 1.

Approximately 75% of people in the U.S. with Hep C have genotype 1

Often people don’t know the genotype of Hep C that they have. But knowing your type of Hep C is important because it helps your Hep C Specialist choose the right treatment for you. It can also affect the length of your treatment. To learn more about genotypes, reach out to your Hep C Specialist.

75%

Important Safety
Information

What should I tell my healthcare provider before taking HARVONI? (continued)

    • Tell your healthcare provider and pharmacist about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. HARVONI and certain other medicines may affect each other, or may cause side effects.

What are the possible side effects of HARVONI?

Serious side effects may also include:

    • Slow heart rate (bradycardia): HARVONI, when taken with amiodarone (Cordarone®, Nexterone®, Pacerone®), a medicine used to treat certain heart problems, may cause slow heart rate, which in some cases has led to death or the need for a pacemaker. Get medical help right away if you take amiodarone with HARVONI and get any of the following symptoms: fainting or near-fainting, dizziness or lightheadedness, not feeling well, weakness, extreme tiredness, shortness of breath, chest pains, confusion, or memory problems.

Continued below

What does it feel like
to let go of Hep C?

See how real people with real cures celebrate letting go of the uncertainties of Hep C.

Be inspired

Important Safety
Information

What are the possible side effects of HARVONI? (continued)

The most common side effects of HARVONI include tiredness, headache and weakness.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see Important Facts about HARVONI including Important Warning.

SEE MORE

HARVONI is a prescription medicine used to treat adults with chronic (lasting a long time) hepatitis C (Hep C) genotype (GT) 1, 4, 5 or 6 infection with or without cirrhosis (compensated). In those with GT 1 and advanced cirrhosis (decompensated) or with GT 1 or 4 with or without cirrhosis (compensated) who have had a liver transplant, HARVONI is used with ribavirin.

Important Safety
Information

What is the most important information I should know about HARVONI?

HARVONI can cause serious side effects, including:

  • Hepatitis B virus reactivation: Before starting HARVONI treatment, your healthcare provider will do blood tests to check for hepatitis B infection. If you have ever had hepatitis B, the hepatitis B virus could become active again during and after treatment with HARVONI. This may cause serious liver problems, including liver failure and death. If you are at risk, your healthcare provider will monitor you during and after taking HARVONI.

What should I tell my healthcare provider before taking HARVONI?

  • Tell your healthcare provider about all of your medical conditions, including if you have ever had hepatitis B infection, liver problems other than hepatitis C infection, or a liver transplant; if you have kidney problems or are on dialysis; if you have HIV; or if you are pregnant or breastfeeding or plan to become pregnant or breastfeed. It is not known if HARVONI will harm your unborn baby or pass into your breast milk. If you take HARVONI with ribavirin, you should also read the ribavirin Medication Guide for important pregnancy-related information.
    • Tell your healthcare provider and pharmacist about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. HARVONI and certain other medicines may affect each other, or may cause side effects.

What are the possible side effects of HARVONI?

Serious side effects may also include:

    • Slow heart rate (bradycardia): HARVONI, when taken with amiodarone (Cordarone®, Nexterone®, Pacerone®), a medicine used to treat certain heart problems, may cause slow heart rate, which in some cases has led to death or the need for a pacemaker. Get medical help right away if you take amiodarone with HARVONI and get any of the following symptoms: fainting or near-fainting, dizziness or lightheadedness, not feeling well, weakness, extreme tiredness, shortness of breath, chest pains, confusion, or memory problems.

The most common side effects of HARVONI include tiredness, headache and weakness.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see Important Facts about HARVONI including Important Warning.

Tap for Use and Important Safety Information about HARVONI including Important Warning on hepatitis B reactivation.

HARVONI, the HARVONI 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.
The content on this site is intended for US residents only.

©2020 Gilead Sciences, Inc. All rights reserved. HVNC0996 11/20

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