EPCLUSA WAS MY KIND OF HEPATITIS C CURE · cured. Cure rates for EPCLUSA ranged from 89% (with...

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EPCLUSA WAS MY KIND OF HEPATITIS C CURE Talk to your Hep C Specialist today. Cure means the Hep C virus is not detected in the blood when measured three months after treatment is completed. EPCLUSA is a prescription medicine used to treat adults with chronic (lasting a long time) hepatitis C (Hep C) genotype 1, 2, 3, 4, 5, or 6 infection with or without cirrhosis (compensated). In those with advanced cirrhosis (decompensated), EPCLUSA is used with ribavirin. Please see Important Facts about EPCLUSA including Important Warning on hepatitis B reactivation on page 10.

Transcript of EPCLUSA WAS MY KIND OF HEPATITIS C CURE · cured. Cure rates for EPCLUSA ranged from 89% (with...

Page 1: EPCLUSA WAS MY KIND OF HEPATITIS C CURE · cured. Cure rates for EPCLUSA ranged from 89% (with prior Hep C treatment and with cirrhosis) to 98% (without prior Hep C treatment and

EPCLUSA WAS MY KIND OF HEPATITIS C CURETalk to your Hep C Specialist today.

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

EPCLUSA is a prescription medicine used to treat adults with chronic (lasting a long time) hepatitis C (Hep C) genotype 1, 2, 3, 4, 5, or 6 infection with or without cirrhosis (compensated). In those with advanced cirrhosis (decompensated), EPCLUSA is used with ribavirin.

Please see Important Facts about EPCLUSA including Important Warning on hepatitis B reactivation on page 10.

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EPCLUSA COULD BE YOUR KIND OF CURE

EPCLUSA has an overall cure rate of 98% across all 6 main genotypes in clinical studies.*98%

CURE RATE

EPCLUSA could be your kind of cure for your kind of Hep C. Most people take one pill, once a day for 12 weeks, with or without food.†

Talk to your Hep C Specialist about EPCLUSA today.

For more information, call 1-844-4-EPCLUSA (1-844-437-2587) or visit EPCLUSA.com.

* In three separate clinical studies with a combined total of 1558 patients with genotype 1–6 Hep C, with or without prior Hep C treatment, and with or without cirrhosis (compensated), who received either EPCLUSA, a different treatment regimen, or placebo, 98% (1015/1035) of all patients who received EPCLUSA once daily for 12 weeks were cured.

These studies did not include patients with advanced cirrhosis (decompensated).‡

† EPCLUSA with ribavirin is recommended for patients with advanced cirrhosis (decompensated).‡ If you take EPCLUSA 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.

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

“ I WANTED MY HEP C GONE.”

What is the most important information I should know about EPCLUSA?EPCLUSA can cause serious side effects, including:

• Hepatitis B virus reactivation: Before starting EPCLUSA 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 EPCLUSA. 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 EPCLUSA.

Please see Important Facts about EPCLUSA including Important Warning on page 10.

2 A B O U T E P C L U S A Actor portrayals throughout

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What should I tell my healthcare provider before taking EPCLUSA? • Tell your healthcare provider about all of your medical conditions, including if

you have ever had hepatitis B infection or liver problems other than hepatitis C infection; 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 EPCLUSA will harm your unborn baby or pass into your breast milk. If you take EPCLUSA with ribavirin, you should also read the ribavirin Medication Guide for important pregnancy-related information.

EPCLUSA is powered by sofosbuvir, the medicine that helped transform Hep C treatment. With EPCLUSA, sofosbuvir and another medicine, velpatasvir, are combined into one pill—creating the first Hep C treatment for all six main Hep C genotypes.

EPCLUSA is brought to you by the makers of HARVONI® (ledipasvir and sofosbuvir). HARVONI revolutionized Hep C treatment for adults with Hep C genotype 1 and has been prescribed to over half a million people.*

A SIGNIFICANT ADVANCEMENT IN HEP C THERAPY

What is HARVONI?

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.

Please see Important Facts about EPCLUSA and HARVONI including Important Warning on pages 10 and 11.

* This information is derived from IMS NPA, IMS NSP™, and IntegriChain® data; data reflect estimated patient starts for HARVONI from 12/2013–3/2018.

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.

3 A B O U T E P C L U S A

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What should I tell my healthcare provider before taking EPCLUSA? (continued)• Tell your healthcare provider and pharmacist about all the medicines you take,

including prescription and over-the-counter medicines, vitamins, and herbal supplements. EPCLUSA and certain other medicines may affect each other, or may cause side effects.

Please see Important Facts about EPCLUSA including Important Warning on page 10.

ONLY ONE PILL, ONCE A DAY,FOR 12 WEEKS.

For most people

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What are the possible side effects of EPCLUSA?Serious side effects may also include:• Slow heart rate (bradycardia): EPCLUSA, when taken with amiodarone (Cordarone®,

Nexterone®, Pacerone®), a medicine used to treat certain heart problems, may cause slow heart rate. In some cases slow heart rate has led to death or the need for a pacemaker when amiodarone is taken with medicines containing sofosbuvir. Get medical help right away if you take amiodarone with EPCLUSA 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 EPCLUSA include headache and tiredness. Tell your healthcare provider if you have any side effect that bothers you or does not go away.

Please see Important Facts about EPCLUSA including Important Warning on page 10.

HIGHLY EFFECTIVE ACROSS ALL 6 MAIN HEP C GENOTYPESIn clinical studies, 12 weeks of EPCLUSA has been shown to have high cure rates in most people:

• With or without compensated cirrhosis

• With or without prior Hep C treatment experience

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

* In a study of 740 patients with genotype 1, 2, 4, 5, or 6 Hep C, with or without prior Hep C treatment, and with or without cirrhosis (compensated), who received either EPCLUSA or placebo for 12 weeks, 98% (323 out of 328) of patients with genotype 1, 100% (116 out of 116) of patients with genotype 4, 97% (34 out of 35) of patients with genotype 5, and 100% (41 out of 41) of patients with genotype 6, who received EPCLUSA once daily for 12 weeks were cured.

† In a study of 266 patients with genotype 2 Hep C, with or without prior Hep C treatment, and with or without cirrhosis (compensated), who received either EPCLUSA or sofosbuvir + ribavirin for 12 weeks, 99% (133 out of 134) of patients who received EPCLUSA once daily for 12 weeks were cured.

‡ In a study of 552 patients with genotype 3 Hep C, with or without prior Hep C treatment, and with or without cirrhosis (compensated), who received either EPCLUSA for 12 weeks or sofosbuvir + ribavirin for 24 weeks, 95% (264 out of 277) of patients who received EPCLUSA once daily for 12 weeks were cured. Cure rates for EPCLUSA ranged from 89% (with prior Hep C treatment and with cirrhosis) to 98% (without prior Hep C treatment and without cirrhosis).

This information does not apply to patients with advanced cirrhosis (decompensated), which is when the liver is extensively scarred and can no longer do its job effectively. Please see page 11 for more information on this patient type.

CURE RATEDOSINGGENOTYPE

1 98%*

2 99%†

3 95%‡

4 100%*

5 97%*

6 100%*

One pill per day

WEEKS OF TREATMENT

12

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“ MY HEP C CAUSED LIVER DAMAGE.”

What is the most important information I should know about EPCLUSA?EPCLUSA can cause serious side effects, including:

• Hepatitis B virus reactivation: Before starting EPCLUSA 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 EPCLUSA. 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 EPCLUSA.

Please see Important Facts about EPCLUSA including Important Warning on page 10.

People who have both Hep C and HIV-1 and people who have Hep C and advanced cirrhosis (decompensated)* can be treated with an EPCLUSA regimen for their Hep C.

It is important to talk with your healthcare provider about your HIV antiretroviral medicine(s) to understand potential interactions with EPCLUSA, or if you have any other questions about your treatment regimen.

If you take EPCLUSA 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.

EPCLUSA CAN TREAT A BROAD RANGE OF PEOPLE

EPCLUSA TREATMENT REGIMENPATIENT TYPE

Hep C genotypes 1-6 with HIV-1 12 weeks

12 weeks with the addition of ribavirin

Hep C genotypes 1-6 with advanced cirrhosis*

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COVERED BY MOST INSURANCE PLANSWhile considering treatment with EPCLUSA, you may be wondering about your insurance coverage or paying for treatment.

Live Support Path program navigators can help you understand your insurance coverage and explain potential cost saving options.

Call a Support Path navigator today at 1-855-7-MYPATH (1-855-769-7284)

EPCLUSA CO-PAY COUPONThe EPCLUSA co-pay coupon may help reduce the out-of-pocket cost of treatment for eligible people.

Call a Support Path navigator or go to EPCLUSA.com/support-path to find out if you are eligible and for full terms and conditions.

You are not eligible if you are enrolled in a government healthcare prescription drug program such as Medicaid or Medicare Part D (including when you are in the coverage gap known as the “donut hole”).

Even if you are not eligible for the co-pay coupon, call a Support Path navigator to learn about other financial resources that may be available to you.

$5Pay As Little As Per Co-pay

Eligible people may pay as little as

$5PER CO-PAY*

*Restrictions apply.

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“ I JUST FOUND OUT ABOUT MY HEP C.”

What should I tell my healthcare provider before taking EPCLUSA? • Tell your healthcare provider about all of your medical conditions, including if

you have ever had hepatitis B infection or liver problems other than hepatitis C infection; 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 EPCLUSA will harm your unborn baby or pass into your breast milk. If you take EPCLUSA with ribavirin, you should also read the ribavirin Medication Guide for important pregnancy-related information.

Please see Important Facts about EPCLUSA including Important Warning on page 10.

GET AN EXPERT ON YOUR SIDESpeak to a Hep C Specialist today about treating your Hep C with EPCLUSA. Here are some questions to help you get the conversation started:

Express yourself and don’t be afraid to ask questions. Explain how Hep C makes you feel and provide as much specific information as possible.

Remember, you are your best advocate.

• Is EPCLUSA right for me?

• What is the most important information I should know about EPCLUSA?

• Have your other patients been able to cure their Hep C with EPCLUSA?

• How long will it take to find out if I am cured?

• What are the possible side effects of EPCLUSA?

Visit EPCLUSA.com to locate a Hep C Specialist near you.

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.

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Please see Important Facts about EPCLUSA including Important Warning on hepatitis B reactivation on page 10.

For more information on EPCLUSA call: 1-844-4-EPCLUSA

YOU MAY BE ELIGIBLE TO PAY AS LITTLE AS $5 PER CO-PAY. RESTRICTIONS APPLY.

VISIT EPCLUSA.COM

Page 10: EPCLUSA WAS MY KIND OF HEPATITIS C CURE · cured. Cure rates for EPCLUSA ranged from 89% (with prior Hep C treatment and with cirrhosis) to 98% (without prior Hep C treatment and

EPCLUSA, the EPCLUSA 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.©2019 Gilead Sciences, Inc. All rights reserved. EPCC0454 12/19

EPCLUSA is a prescription medicine used to treat adults with chronic (lasting a long time) hepatitis C (Hep C) genotype 1, 2, 3, 4, 5, or 6 infection with or without cirrhosis (compensated). In those with advanced cirrhosis (decompensated), EPCLUSA is used with ribavirin.

ABOUT EPCLUSA

EPCLUSA can cause serious side effects, including: Hepatitis B virus reactivation: Before starting treatment with EPCLUSA, 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 or after treatment with EPCLUSA. This may cause serious liver problems including liver failure and death. Your healthcare provider will monitor you if you are at risk for hepatitis B reactivation during and after you stop taking EPCLUSA.

MOST IMPORTANT INFORMATION ABOUT EPCLUSA

Tell your healthcare provider about all of your medical conditions, including if you:• have ever had hepatitis B virus infection • have liver problems other than hepatitis C infection• have kidney problems or you are on dialysis• have HIV-1 infection• are pregnant or breastfeeding, or plan

to become pregnant or breastfeed If you take EPCLUSA with ribavirin, you should also read the ribavirin Medication Guide for important pregnancy-related information.

Tell your healthcare provider about all the medicines you take:• Keep a list that includes all prescription and

over-the-counter medicines, vitamins, and herbal supplements, and show it to your healthcare provider.

• EPCLUSA and certain medicines may affect each other, or cause side effects.

BEFORE TAKING EPCLUSA

• This is only a brief summary of important information about EPCLUSA. Talk to your healthcare provider or pharmacist to learn more.

• Go to EPCLUSA.com or call 1-844-4-EPCLUSA.

• To learn about potential savings, call 1-855-7-MYPATH or go to EPCLUSA.com/support-path.

GET MORE INFORMATION

IMPORTANT FACTSThis is only a brief summary of important information about EPCLUSA and does not replace talking to your healthcare provider about your condition and your treatment.(ep-KLOO-suh)

EPCLUSA can cause serious side effects, including: • Those in the “Most Important Information

about EPCLUSA” section.• Slow heart rate (bradycardia): EPCLUSA, 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 pacemaker when amiodarone is taken with medicines containing sofosbuvir. Get medical help right away if you take amiodarone with EPCLUSA and get any of the following symptoms:

• fainting or near-fainting • extreme tiredness• dizziness or • shortness of breath lightheadedness • chest pains• not feeling well • confusion• weakness • memory problems

The most common side effects of EPCLUSA include headache and tiredness. 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 EPCLUSA. For more information, ask your healthcare provider or pharmacist. You may report side effects to FDA at 1-800-FDA-1088.

POSSIBLE SIDE EFFECTS OF EPCLUSA

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EPCLUSA, the EPCLUSA logo, 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.

©2020 Gilead Sciences, Inc. All rights reserved. PTFC0486 03/20

HARVONI is a prescription medicine used to treat adults and children 3 years of age and older with chronic (lasting a long time) hepatitis C genotype (GT) 1, 4, 5, or 6 infection with or without cirrhosis (compensated). In people with GT 1 infection and advanced cirrhosis (decompensated) or with GT 1 or 4 infection with or without cirrhosis (compensated) who have had a liver transplant, HARVONI is used with ribavirin.

ABOUT HARVONI

HARVONI can cause serious side effects, including: Hepatitis B virus reactivation: Before starting treatment with HARVONI, 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 or after treatment with HARVONI. This may cause serious liver problems, including liver failure and death. Your healthcare provider will monitor you if you are at risk for hepatitis B reactivation during and after you stop taking HARVONI.

MOST IMPORTANT INFORMATION ABOUT HARVONI

Tell your healthcare provider about all of your medical conditions, including if you:• have ever had hepatitis B virus infection• have liver problems other than hepatitis C

infection• had a liver transplant• have kidney problems or are on dialysis• have HIV infection• are pregnant or breastfeeding, or plan to

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

Tell your healthcare provider about all the medicines you take:• Keep a list that includes all prescription and

over-the-counter medicines, vitamins, and herbal supplements, and show it to your healthcare provider.

• HARVONI and certain medicines may affect each other, or cause side effects.

BEFORE TAKING HARVONI

• This is only a brief summary of important information about HARVONI. Talk to your healthcare provider or pharmacist to learn more.

• Go to HARVONI.com or call 1-844-READY41. • To learn about potential savings, call

1-855-7-MYPATH or go to HARVONI.com/support.

GET MORE INFORMATION

IMPORTANT FACTSThis is only a brief summary of important information about HARVONI and does not replace talking to your healthcare provider about your condition and your treatment.(har-VOE-nee)

HARVONI can cause serious side effects, including:• Those in the “Most Important Information about

HARVONI” section.• 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 • extreme tiredness• dizziness or • shortness of breath lightheadedness • chest pains• not feeling well • confusion• weakness • memory problems

The most common side effects of HARVONI include tiredness, headache, and weakness.These are not all the possible side effects of HARVONI. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

POSSIBLE SIDE EFFECTS OF HARVONI

Family of Cures

Family of Cures

Family of Cures

HARVONI, the HARVONI 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. ©2019 Gilead Sciences, Inc. All rights reserved. HVNC0982 12/19

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