Clinical Study Results | HARVONI® (ledipasvir 90 mg/sofosbuvir 400 mg) tablets

A simple treatment regimen for Hep C

HARVONI treatment is just one pill, once a day for the majority of patients—no interferon, no complicated regimens.

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.

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

In all cases, treatment depends on the specifics of your particular situation. However, 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

Cure rates by patient type Based on clinical studies

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

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	Cure Rate
Never Treated With Lower Levels of Virus in Body (Less Than 6 million IU per mL)	8	97%*
Never Treated	12	96–99%^†
Previously Treated	12	95%^‡

Genotype 1 Adults With Compensated Cirrhosis
Hep C Treatment History	Weeks of Treatment	Cure Rate
Never Treated	12	94%^§
Previously Treated	24^\|\|	97–100%^¶#

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.

*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.

^†In a study of 865 patients with genotype 1 Hep C, with no prior Hep C treatment, 99% (176 out of 177) of patients without cirrhosis 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 440 patients with genotype 1 Hep C who had failed prior Hep C therapy, 95% (83 out of 87) of patients without cirrhosis who received HARVONI once daily for 12 weeks were cured.

^§In a study of 865 patients with genotype 1 Hep C, with no prior Hep C treatment, 94% (32 out of 34) of patients with compensated cirrhosis who received HARVONI once daily for 12 weeks were cured.

^||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.

^¶In a study of 155 patients with genotype 1 Hep C who had failed prior Hep C therapy twice and had compensated cirrhosis, 96% (74 out of 77) of patients who received HARVONI once daily plus ribavirin for 12 weeks and 97% (75 out of 77) of patients who received HARVONI once daily without ribavirin for 24 weeks were cured.

^#In a study of 440 patients with genotype 1 Hep C who had failed prior Hep C therapy, 100% (22 out of 22) of those patients who had compensated cirrhosis and received HARVONI once daily for 24 weeks were cured.

**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	Cure Rate
4	12	93%*
5	12	93%*
6	12	96%^†

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.

Study results for genotypes 4, 5, and 6 are based on limited numbers of patients with prior Hep C treatment and patients with compensated cirrhosis.

*In a study of 85 patients with Hep C genotype 4 or 5 Hep C, with or without prior Hep C treatment, and without cirrhosis or with compensated cirrhosis, 93% (41 out of 44) of patients with genotype 4 and 93% (38 out of 41) of patients with genotype 5 who received HARVONI once daily for 12 weeks were cured.

^†In a study of 25 patients with Hep C genotype 6, with or without prior Hep C treatment and without cirrhosis or with compensated cirrhosis, 96% (24 out of 25) were cured after 12 weeks of therapy with HARVONI once daily.

^‡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.

Learn about side effects with HARVONI

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.

Continued below

What is cirrhosis?

Unfortunately, over time, chronic Hep C can cause a type of liver damage called cirrhosis, which may eventually lead to advanced cirrhosis.

Cirrhosis is a type of advanced liver disease in which healthy liver tissue is replaced with scar tissue
Advanced cirrhosis (also known as decompensated cirrhosis) is when the liver is extensively scarred and can no longer do its job effectively

To determine if you have cirrhosis, your Hep C Specialist may order a blood test, perform imaging, and/or perform a biopsy to take a closer look at your liver.

Get answers to more of your questions

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.

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.

A simple treatment regimen for Hep C

Cure rates by patient type Based on clinical studies

Hep C & HIV-1

Advanced Cirrhosis or Liver Transplant

Important Safety Information

Important Safety Information

Important Safety Information

Important Safety
Information

Important Safety
Information

Important Safety
Information