A BREAKTHROUGH TREATMENT FOR HEP C

Until now, there’s been no other treatment for patients with Hep C genotype 2 or genotype 3 (GT2 or GT3) like EPCLUSA—the first and only treatment for patients with Hep C GT2 and GT3 that is one pill, once a day for the majority of patients.*

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.

In clinical studies, EPCLUSA had high overall cure rates of 99% for GT2 patients and 95% for GT3 patients. EPCLUSA was also found to be highly effective in patients with GT1, GT4, GT5 and GT6, with overall cure rates ranging from 97–100%.§ Cure means the Hep C virus is not detected in the blood when measured three months after treatment is completed.

With EPCLUSA, there’s no interferon and no complex regimens.

*EPCLUSA with ribavirin is recommended for patients with advanced cirrhosis.|| If you take EPCLUSA with ribavirin, you should also read the ribavirin Medication Guide for important pregnancy-related information.

In a study of 266 patients with genotype 2 Hep C, with or without prior Hep C treatment, and with or without cirrhosis, 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, 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).

§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, 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.

These studies did not include patients with advanced cirrhosis.||

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

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.

Important Safety Information

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.

What should I tell my healthcare provider before taking EPCLUSA?

  • If you have: ever had hepatitis B infection, liver problems other than hepatitis C infection; severe kidney problems or are on dialysis; any other medical condition; 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. If you take EPCLUSA with ribavirin, you should also read the ribavirin Medication Guide for important pregnancy-related information.

Continued below

ANOTHER STEP FORWARD IN HEP C TREATMENT

EPCLUSA is a breakthrough therapy that’s been proven to effectively treat all six main Hep C genotypes (GTs). (See below for more information on genotypes.) This is a particularly significant advancement for patients with GT2 or GT3 who did not previously have a simple one-pill, once-a-day treatment option, with just 12 weeks of therapy.

EPCLUSA is brought to you by the makers of HARVONI® (ledipasvir and sofosbuvir)—the medicine that revolutionized Hep C treatment for adults with Hep C genotype 1 and has been prescribed to more than a quarter of a million patients.* Please see Important Safety Information about HARVONI including Important Warning on hepatitis B reactivation.

*This information is derived from IMS NPA, IMS NSP™, and IntegriChain® data; data reflect estimated patient starts for HARVONI from October 2014–September 2016.

HARVONI and EPCLUSA are powered by sofosbuvir, the medicine that is transforming Hep C treatment

Certain patients will need to have ribavirin added to their regimen.

Not currently working with a Hep C Specialist?
FIND ONE HERE

Important Safety Information

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. Tell your healthcare provider if you take any medicines containing tenofovir disoproxil fumarate (ATRIPLA®, COMPLERA®, STRIBILD®, TRUVADA®, VIREAD®).

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 and another antiviral medicine. 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.

Continued below

KNOWING YOUR HEP C GENOTYPE IS IMPORTANT

Just as there are different blood types, there are also different types of Hep C, called genotypes. There are 6 main genotypes, numbered 1 through 6.

In clinical studies, EPCLUSA was effective in treating patients with all 6 genotypes—a significant breakthrough in itself, but especially so for patients with genotypes 2 and 3. In the past, treatment regimens for Hep C genotypes 2 and 3 often included multiple separate medicines and complicated dosing. If you have Hep C genotype 1, 4, 5, or 6, learn about another treatment option that may be right for you.

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. To learn more about genotypes, reach out to your Hep C Specialist.

GET STARTED WITH EPCLUSA

Important Safety Information

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

The most common side effects of EPCLUSA include headache and tiredness. When EPCLUSA is used with ribavirin for patients with advanced cirrhosis, side effects also include anemia, nausea, insomnia, and diarrhea.

Please see Important Facts about EPCLUSA including Important Warning.

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.

Important Safety Information

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.

What should I tell my healthcare provider before taking EPCLUSA?

  • If you have: ever had hepatitis B infection, liver problems other than hepatitis C infection; severe kidney problems or are on dialysis; any other medical condition; 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. If you take EPCLUSA 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. EPCLUSA and certain other medicines may affect each other, or may cause side effects. Tell your healthcare provider if you take any medicines containing tenofovir disoproxil fumarate (ATRIPLA®, COMPLERA®, STRIBILD®, TRUVADA®, VIREAD®).

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 and another antiviral medicine. 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. When EPCLUSA is used with ribavirin for patients with advanced cirrhosis, side effects also include anemia, nausea, insomnia, and diarrhea.

Please see Important Facts about EPCLUSA including Important Warning.

Thinking about treatment with EPCLUSA? Sign up for Onward and get free step-by-step guidance to help you get started.

MOVE ONE STEP CLOSER
X
HARVONI® (ledipasvir 90 mg/sofosbuvir 400 mg)

HEP C TREATMENT WAS TRANSFORMED WITH HARVONI

Before EPCLUSA, HARVONI revolutionized Hep C treatment by combining two drugs (ledipasvir and sofosbuvir) into one pill. HARVONI was the first cure that’s one pill, once a day for the majority of patients.

In clinical studies, HARVONI was proven to cure 96–99% of adult patients who had Hep C genotype 1 and no prior treatment with just 12 weeks of therapy.* Certain patients were cured with just 8 weeks of therapy. Cure means the Hep C virus is not detected in the blood when measured three months after treatment is completed.

Like HARVONI, EPCLUSA is a clear step forward in Hep C treatment. See EPCLUSA clinical study results here.

*In a study of 865 patients with genotype 1 Hep C and no prior Hep C treatment, with or without cirrhosis, 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 genotype 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 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.

What is HARVONI?

HARVONI is a prescription medicine used with or without ribavirin to treat chronic (lasting a long time) hepatitis C genotype 1, 4, 5 or 6 infection. It is not known if HARVONI is safe and effective in children under 18 years of age.

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?

  • If you have: ever had hepatitis B infection, liver problems other than hepatitis C infection, or have had a liver transplant; severe kidney problems or are on dialysis; HIV, or any other medical condition; 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. Tell your healthcare provider if you take any medicines containing tenofovir disoproxil fumarate (ATRIPLA®, COMPLERA®, STRIBILD®, TRUVADA®, VIREAD®).

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 on hepatitis B reactivation.

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