IF YOU HAVE CHRONIC HEPATITIS C (HEP C), DAKLINZA MAY BE ABLE TO HELP

ABOUT DAKLINZA (daclatasvir)

Why Daklinza plus sofosbuvir* may be
right for you1

If you have chronic (lasting a long time) Hep C, your healthcare provider will decide what treatment is right for you, often based on:

Daklinza (60 mg) plus sofosbuvir (with or without ribavirin)* combination therapy is an all-oral treatment.

These treatments may cureCure Close ButtonCure means that no Hep C virus was detected in the blood when tested 12 weeks after treatment ends.3  your chronic Hep C genotype 1 or 3, even if you have been unsuccessful in treating your Hep C before.

These treatments may cureCure Close ButtonCure means that no Hep C virus was detected in the blood when tested 12 weeks after treatment ends.3  your chronic Hep C genotype 1 or 3, even if you have been unsuccessful in treating your Hep C before.

  • However, Daklinza may not work as well in some patients with cirrhosis (in clinical trials, the cure rate was lower)
 
*Based on the health of your liver, your healthcare provider may add ribavirin to your treatment.

SELECTED IMPORTANT SAFETY
INFORMATION

What is the most important information I should know about Daklinza?

  • Daklinza can cause serious side effects, including Hepatitis B virus reactivation. Your healthcare provider will do blood tests to check for hepatitis B virus infection before starting Daklinza. If you have ever had hepatitis B virus infection, the virus could become active again (called reactivation) during or after treatment with Daklinza. 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 virus reactivation during treatment and after stopping Daklinza.

Before taking Daklinza, tell your healthcare provider about all your medical conditions, including if you:

  • Have ever had hepatitis B virus infection; have liver problems other than hepatitis C infection; have had a liver transplant; have heart problems; or if you are pregnant or breastfeeding or plan to become pregnant or breastfeed. It is not known if Daklinza will harm your unborn baby or pass into your breast milk. When taking Daklinza in combination with sofosbuvir and ribavirin, tell your healthcare provider right away if you or your female sexual partner become pregnant. Males and females on this regimen should also read the ribavirin Medication Guide for important pregnancy, contraception, and infertility information.

How does this treatment work?1

 

Results from 3 clinical studies with Daklinza treatment regimens1,2

In a clinical study, 90% of patients with chronic Hep C (genotype 3 only) who had never been treated before achieved a cureCure Close ButtonCure means that no Hep C virus was detected in the blood when tested 12 weeks after treatment ends.3  after 12 weeks of treatment with all-oral, once-daily Daklinza plus sofosbuvir2

Furthermore, 86% of patients who had failed previous treatment also achieved a cureCure Close ButtonCure means that no Hep C virus was detected in the blood when tested 12 weeks after treatment ends.3 .

In a study of 152 chronic Hep C genotype 3 patients with and without cirrhosis1

HepC Patient Study HepC Patient Study
  

Please see below for side effects and additional safety information.

  

In another clinical study, people with both chronic Hep C genotype 3 and HIV achieved a 100% Hep C cureCure Close ButtonCure means that no Hep C virus was detected in the blood when tested 12 weeks after treatment ends.3  rate after taking Daklinza plus sofosbuvir for 12 weeks. 97% of patients with both chronic Hep C genotype 1 and HIV also achieved a Hep C cureCure Close ButtonCure means that no Hep C virus was detected in the blood when tested 12 weeks after treatment ends.3 .1†

Daklinza does not treat or cure HIV.

In a study of 137 patients with both chronic Hep C and HIV, with and without cirrhosis (genotype 1 and 3)

HepC Patient Study HepC Patient Study
  

Please see below for side effects and additional safety information.

  

 

In still another clinical study, 82% of chronic Hep C genotype 1 patients with advanced cirrhosis, and 95% with genotype 1 who had a liver transplant, achieved a Hep C cureCure Close ButtonCure means that no Hep C virus was detected in the blood when tested 12 weeks after treatment ends.3 .1

In this study, 83% of people who had genotype 3 and advanced cirrhosis, and 91% of those with genotype 3 who had a liver transplant, achieved a Hep C cureCure Close ButtonCure means that no Hep C virus was detected in the blood when tested 12 weeks after treatment ends.3 .

In a study of 86 chronic Hep C patients with advanced cirrhosis or who had a liver transplant (genotype 1) taking Daklinza plus sofosbuvir and ribavirin for 12 weeks

HepC Patient Study HepC Patient Study
For information about advanced cirrhosis, please see the About Hepatitis C page of this website, or talk to your healthcare provider.

Please see below for side effects and additional safety information.

In the clinical studies, there were no serious side effects due to treatment with Daklinza plus sofosbuvir (with or without ribavirin)1

Most common side effects (seen in at least 10% of patients in each clinical study across all genotypes)

References: 1. Daklinza [package insert]. Princeton, NJ: Bristol-Myers Squibb Company. 2. Nelson DR, Cooper JN, Lalezari JP, et al. All-oral, 12-week treatment with daclatasvir plus sofosbuvir in patients with hepatitis C virus genotype 3 infection: ALLY-3 phase 3 study. Hepatology. 2015;61:1127-1135. doi: 10.1002/hep.27726. 3. AASLD/IDSA/IAS-USA. When and in whom to initiate HCV therapy. Recommendations for testing managing and treating hepatitis C. http://www.hcvguidelines.org/full-report/when-and-whom-initiate-hcv-therapy. Accessed November 19, 2015. 4. Centers for Disease Control and Prevention. Hepatitis C FAQs for Health Professionals. http://www.cdc.gov/hepatitis/hcv/hcvfaq.htm. Accessed November 19, 2015. 5. Tapper EB, Afdhal NH. Is 3 the new 1: perspectives on virology, natural history and treatment for hepatitis C genotype 3. J Virol Hepat. 2013;20:669-677. 6. Bochud PY, Cai T, Overbeck K, et al. Genotype 3 is associated with accelerated fibrosis progression In chronic hepatitis C. J Hepatol. 2009;51:655-666.
 

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about Daklinza?

  • Daklinza can cause serious side effects, including Hepatitis B virus reactivation. Your healthcare provider will do blood tests to check for hepatitis B virus infection before starting Daklinza. If you have ever had hepatitis B virus infection, the virus could become active again (called reactivation) during or after treatment with Daklinza. 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 virus reactivation during treatment and after stopping Daklinza.

Before taking Daklinza, tell your healthcare provider about all your medical conditions, including if you:

  • Have ever had hepatitis B virus infection; have liver problems other than hepatitis C infection; have had a liver transplant; have heart problems; or if you are pregnant or breastfeeding or plan to become pregnant or breastfeed. It is not known if Daklinza will harm your unborn baby or pass into your breast milk. When taking Daklinza in combination with sofosbuvir and ribavirin, tell your healthcare provider right away if you or your female sexual partner become pregnant. Males and females on this regimen should also read the ribavirin Medication Guide for important pregnancy, contraception, and infertility information.
  • Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Daklinza may affect the way other medicines work, and other medicines may affect how Daklinza works. Do not start taking a new medicine without telling your healthcare provider.
  • Daklinza in combination with sofosbuvir and amiodarone may cause serious side effects, including slow heart rate (bradycardia). Get medical help right away if you take amiodarone with sofosbuvir and Daklinza and get any of the following: fainting or near-fainting, weakness, chest pain, dizziness or lightheadedness, tiredness, confusion, not feeling well, shortness of breath, memory problems.

What are the most common side effects of Daklinza and sofosbuvir?
Headache, tiredness.

What are the most common side effects of Daklinza when used with sofosbuvir and ribavirin?
Headache, low red blood cell count, tiredness, nausea.

These are not all the possible side effects of Daklinza; call your doctor concerning side effects.

Please see Full Prescribing Information, including "What is the most important information I should know about Daklinza?" in the Patient Information section.

 

More Important Safety Information

SELECTED IMPORTANT SAFETY INFORMATION

Before taking Daklinza, tell your healthcare provider about all your medical conditions, including if you:

  • Have ever had hepatitis B virus infection; have liver problems other than hepatitis C infection; have had a liver transplant; have heart problems; or if you are pregnant or breastfeeding or plan to become pregnant or breastfeed. It is not known if Daklinza will harm your unborn baby or pass into your breast milk. When taking Daklinza in combination with sofosbuvir and ribavirin, tell your healthcare provider right away if you or your female sexual partner become pregnant. Males and females on this regimen should also read the ribavirin Medication Guide for important pregnancy, contraception, and infertility information.