About Hepatitis C

Hepatitis C (Hep C) is a contagious liver disease. It’s caused by the Hep C virus and over time may result in serious liver damage, including liver failure. In the US, it’s estimated that about 3.5 million adults have chronic Hep C. But because the disease progresses slowly and often shows no symptoms, many of those with Hep C don’t know they have it. And they may be unaware that Hep C is curable.

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.

ABOUT 3.5 MILLION ADULTS HAVE CHRONIC HEP C AND THEY MAY BE UNAWARE THAT HEP C IS CURABLE

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 (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

How Hep C Is Transmitted

The virus that causes Hep C is carried in the blood. For it to be spread, the blood of a person who has the virus has to get into the bloodstream of an uninfected person. Although there are many ways that this can happen, there are certain factors that can put people at a higher risk, including:

    • Being born between 1945 and 1965
    • Being born to a mother with Hep C
    • Having an organ transplant before 1992
    • Having a blood transfusion before 1992
    • Injecting illegal drugs—even if it was years ago, or just once
    • Having HIV or AIDS
    • Being exposed to blood from someone with Hep C
    • Having a history of long-term kidney dialysis
Hep C spreads through
contact with the blood of
a person who has the virus.

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 severe 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

Hep C Symptoms

A person can have Hep C for years—or decades—without feeling sick. By the time symptoms occur, they often signal that damage to the liver is advanced. Some symptoms that can occur are:

    • Fever
    • Not wanting to eat
    • Upset stomach
    • Throwing up
    • Feeling tired
    • Dark-colored urine
    • Gray-colored stool
    • Yellow skin and eyes (jaundice)
    • Joint pain
A person can
have Hep C
for many
years without
symptoms.

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

There Are Different Types of Hep C

Just as there are different blood types, there are different types of the Hep C virus. These are called genotypes and can be determined by a basic blood test. The most common type of Hep C in the US is genotype 1. For people who have Hep C, knowing which genotype is important. This information can help their healthcare provider choose the right treatment for them.

For people who have Hep C, knowing which genotype is important.

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

Getting Treatment for Hep C

There are healthcare providers who have had special training in Hep C treatment and are among the most informed about the various types of available treatment. Hep C Specialists come from different fields of practice and can include:

    • Gastroenterologists (specialists in diseases of the digestive system)
    • Hepatologists (specialists in diseases of the liver)
    • Infectious disease (ID) specialists
    • Primary care physicians (PCPs)
    • Internal medicine specialists (internists)
    • Nurse practitioners (NPs)
    • Physician assistants (PAs)
Find a local Hep C Specialist

Important Safety
Information

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

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

Hep C Is Curable

More people have been prescribed HARVONI to cure their Hep C than any other advanced treatment regimen.*

1/4 MILLION+
PEOPLE HAVE BEEN PRESCRIBED
HARVONI TO CURE THEIR HEP C

HARVONI transformed Hep C treatment as the first cure with a simple regimen that's one pill, once a day, for 12 weeks for the majority of patients with genotypes 1, 4, 5, or 6. Cure means the Hep C virus is not detected in the blood when measured 3 months after treatment is completed.

*Based on retail pharmacy prescription data (IMS New to Brand™) for US patients starting Hep C treatment with advanced treatment regimens (including direct-acting antiviral medicines) from 5/2011—9/2016.

This information is derived from IMS NPA, IMS NSP™, and IntegriChain® data; data reflect estimated patient starts for HARVONI from 10/2014—9/2016.

Learn more at HARVONI.com

Learn about a treatment for Hep C genotypes other than 1, 4, 5, or 6

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.

Please see Important Facts about HARVONI including Important Warning.

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

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 severe 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.

Please see Important Facts about HARVONI including Important Warning.

©2017 Gilead Sciences, Inc. All rights reserved. HVNC0749 08/17