Summary Information for Patients (for completion by Industry)
Product
Applicant Company
Date of Submission
Daclatasvir (Daklinza®)
Bristol Myers Squibb Pharmaceuticals Ltd.
7th July 2014
This document has been completed by the applicant company in relation to the above
product.
The Scottish Medicines Consortium will be undertaking a review of this product [on date] and
a submission of evidence has been received from the applicant company for this purpose.
In addition to the submission of evidence, the attached document has been supplied as a
supplement for the purposes of patient and public interest groups.
This document does not represent the views of the Scottish Medicines Consortium and the
SMC secretariat act only as a communication channel to forward this document to the
relevant interested parties.
Should you have any queries regarding the completion of this form,
please contact the SMC secretariat:
Telephone: 0141 225 6874/5552
Patient Interest Group Summary
Submission of Evidence Template
Name of Company
Company Representative name and contact
details
Product to which this submission relates
Bristol-Myers Squibb Pharmaceuticals Ltd
Daclatasvir (Daklinza®)
Company Details
Bristol-Myers Squibb Pharmaceuticals Ltd
Uxbridge Business Park,
Sanderson Road,
Uxbridge,
Middlesex
UB8 1DH
Name of Product
Daclatasvir (Daklinza®)
Indication (Disease to be treated)
Daclatasvir is used to treat adults with chronic hepatitis C, an infectious disease caused by
the hepatitis C virus, which affects the liver. Daclatasvir should be taken with other
treatments licensed for treating chronic hepatitis C.1
How does the product work
When a person is infected with the hepatitis C virus, the liver is targeted and becomes
inflamed; this is known as hepatitis. The longer the virus remains in the body, the worse the
damage to the liver becomes.
Daclatasvir targets the hepatitis C virus, making it unable to multiply and infect new cells.
Over time, the remaining virus is removed naturally from the blood.
The recommended dose is one 60mg daclatasvir tablet once a day, taken for as long as
recommended by the doctor.
The total duration of treatment (varies between 12 and 48 weeks) depends predominantly
on:
 The treatments to be used in combination with daclatasvir
 The particular type of hepatitis C virus the person is infected with (type 1, 3 or 4)
 whether the person has previously received treatment for hepatitis C
 the extent of damage to the liver
How effective is the product
Daclatasvir regimens have been shown to be extremely effective.1-3 This effectiveness is
maintained even in patients that would have previously been very difficult to treat. Depending
on the combination of medicines used, the virus was cleared in 78–100% of patients in
relevant clinical trials.
What are the side effects associated with this product
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Compared to treatments that have previously been used for chronic hepatitis C, daclatasvir is
very well tolerated. Side effects that have been observed are those that are expected with
antiviral agents, and are generally mild and easily managed.
Common (may affect more than 1 in 10 people):
 headache, nausea, fatigue
Very common (may affect up to 1 in 10 people):
 decreased appetite, difficulty sleeping, dizziness, migraine, shortness of breath,
medicine tastes abnormal, hot flush
 itching, dry skin, unusual hair loss or thinning, rash
 diarrhoea, upper abdominal pain, constipation, excessive gas in the stomach or
bowel, heartburn, vomiting
 cough, nasal congestion (blocked nose), dry mouth
 joint pain, aching or tender muscles, not caused by exercise
 depression, anxiety, irritability
 reduction in red blood cells (anaemia)
Who should not use this product
Like all medicines, daclatasvir should not be used by people who have a known allergy to daclatasvir
itself, or to any of the other ingredients in the daclatasvir tablets. Daclatasvir tablets contain lactose;
therefore, if the person has an intolerance to some sugars, they should tell their doctor before taking
daclatasvir.
Daclatasvir should not be taken if the person using it is taking any of the following medicines,
as they may reduce how well daclatasvir works:
 phenytoin, carbamazepine, oxcarbazepine or phenobarbital: these are used to treat
epileptic seizures
 rifampicin, rifabutin or rifapentine: these are antibiotics used to treat tuberculosis
 dexamethasone: this is a steroid used to treat allergic and inflammatory diseases
 medicines containing St. John’s wort (a herbal preparation)
Daclatasvir is not recommended for people under 18 years of age.
Daclatasvir should not be taken by a person who is pregnant, think they may be pregnant or is
planning to become pregnant.
As it is not known whether daclatasvir passes into human breast milk, the person should not breastfeed
when taking daclatasvir.
As a precaution, anyone taking daclatasvir should tell their doctor:
 if they are infected with human immunodeficiency virus (HIV) or hepatitis B virus
 if they have had, or plan to have, a liver (or another) organ transplant
 if their liver is damaged and not functioning properly (also called ‘decompensated
liver disease’)
Any of the above conditions may require the dose of daclatasvir to be altered.
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What are the potential benefits of this product
In patients treated with a daclatasvir regimen, it is expected that most people will be cured
(as measured by the removal of the virus from the body) with one round of treatment,
regardless of what type of hepatitis C virus they are infected with (1, 3 or 4) or whether they
have been previously treated.
Daclatasvir comes as a tablet to be taken once-daily, making it convenient and simple to
take.
Daclatasvir has less side effects than previous hepatitis C treatments.
References
1.
2.
3.
Bristol-Myers Squibb Pharmaceuticals Ltd. Summary of Product Characteristics.
Daklinza 30 mg and 60 mg film-coated tablets. 2014.
Sulkowski MS, Gardiner DF, Rodriguez-Torres M, Reddy KR, Hassanein T, Jacobson
I, et al. Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV
infection. New England Journal of Medicine. 2014;370(3):211-21.
European Medicines Agency. European Medicines Agency recommends approval of
Daklinza in chronic hepatitis C. 2014. Available at:
http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2014/06/WC
500169370.pdf [Accessed June 2014].
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