HARVONI
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HARVONI gives you what you need

HARVONI transformed hepatitis C (Hep C) treatment as the first cure that’s one pill, once a day for the majority of patients.

Cure means the Hep C virus is not detected in the blood when measured 3 months after treatment is completed.

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

No interferon.
No complicated regimens.

For specific patients, such as those who have had a liver transplant or are experiencing advanced cirrhosis,* it is recommended that ribavirin be added to their HARVONI regimen. If you take HARVONI with ribavirin, you should also read the ribavirin Medication Guide for important pregnancy-related information. Your Hep C Specialist will determine the regimen that’s right for you.

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*Advanced cirrhosis (decompensated) is when the liver is extensively scarred and can no longer do its job effectively.

Learn about treatment length with HARVONI below

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

Treatment with HARVONI
Play
Three months after I finished the treatment…I was cured. — Terry C., Fresno, CA

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

Length of treatment with HARVONI

Most patient types are recommended to receive 12 weeks of treatment, although 8 or 24 weeks may also be prescribed. Your Hep C Specialist will determine your treatment regimen and length based on your individual case. Read more

Your Hep C Specialist will likely consider:

  • Your genotype (If you don’t have Hep C genotype 1, 4, 5, or 6, learn about another treatment option that may be right for you.)
  • Whether or not you have been treated before (treatment history)
  • The level of virus in your body (viral load)
  • The presence and extent of liver damage
  • Whether or not you have had a liver transplant

Treatment length by patient type

GT 1
GT 4,
5, or 6
Hep C
& HIV-1
Advanced
Cirrhosis/
Liver
Transplant

Genotype 1 Adults Without Cirrhosis
Hep C Treatment History Weeks of
Treatment
Never Treated With Lower Levels of Virus in Body (Less Than 6 million IU per mL) 8
Never Treated 12
Previously Treated 12
Genotype 1 Adults With Compensated Cirrhosis
Hep C Treatment History Weeks of
Treatment
Never Treated
 
 
 
 		12
Previously Treated 24*
   

This information does not apply to patients with advanced cirrhosis (decompensated)† or those who have had a liver transplant. Please see “Advanced Cirrhosis/Liver Transplant” tab for HARVONI treatment recommendations for these patients.

*HARVONI plus ribavirin for 12 weeks can be considered in previously treated genotype 1 patients with compensated cirrhosis who are eligible for ribavirin. If you take HARVONI with ribavirin, you should also read the ribavirin Medication Guide for important pregnancy-related information.

†Advanced cirrhosis (decompensated) is when the liver is extensively scarred and can no longer do its job effectively.

Adults With Genotype 4, 5, or 6 With or Without Compensated Cirrhosis
Genotype Weeks of
Treatment
4 12
5 12
6 12

This information does not apply to patients with advanced cirrhosis (decompensated)* or those who have had a liver transplant. Please see “Advanced Cirrhosis/Liver Transplant” tab for HARVONI treatment recommendations for these patients.

*Advanced cirrhosis (decompensated) is when the liver is extensively scarred and can no longer do its job effectively.

Hep C & HIV-1

For patients with both Hep C and HIV-1, the recommended HARVONI treatment regimen and length is the same as that for someone without HIV-1. Please refer to the charts on tabs 1 and 2 for treatment information for your specific genotype.

It is important to talk with your healthcare provider about your HIV antiretroviral medicine(s) to understand potential interactions with HARVONI.

Advanced Cirrhosis or Liver Transplant

For patients with advanced cirrhosis (decompensated)* and Hep C genotype 1, HARVONI plus ribavirin provides an all-oral treatment option with just 12 weeks of therapy.

For patients who have had a liver transplant, don’t have advanced cirrhosis, and have Hep C genotype 1 or 4, HARVONI plus ribavirin provides an all-oral treatment option with just 12 weeks of therapy.

It’s important to talk to your Hep C Specialist about your individual situation to find out if this treatment regimen is right for you.

If you take HARVONI with ribavirin, you should also read the ribavirin Medication Guide for important pregnancy-related information.

*Advanced cirrhosis (decompensated) is when the liver is extensively scarred and can no longer do its job effectively.

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.

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?

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

How should you take HARVONI?

HARVONI tablet

Not actual size

  • Take HARVONI 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 HARVONI without first talking with your healthcare provider. If you think there is a reason to stop taking HARVONI, talk to your healthcare provider before doing so.

  • Take HARVONI 1 time each day and at the same time each day.

  • Take HARVONI with or without food.

  • It is important that you do not miss or skip doses of HARVONI during treatment.

  • If you take too much HARVONI, call your healthcare provider or go to the nearest hospital emergency room right away.

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.
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