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EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)
VIRAFERONPEG
EPAR summary for the public
This document is a summary of the European Public Assessment Report (EPAR). It explains how the Committee for Medicinal products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine. If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
What is ViraferonPeg?
ViraferonPeg is a medicine containing the active substance peginterferon alfa-2b. It is available as a
powder and solvent to be made up into a solution for injection, and as a single use pre-filled pen.
These all contain 50, 80, 100, 120, or 150 micrograms of peginterferon alfa-2b per 0.5 ml.
What is ViraferonPeg used for?
ViraferonPeg is used to treat adult patients with chronic (long-term) hepatitis C (a disease of the liver
due to an infection with the hepatitis C virus). ViraferonPeg is used in patients whose liver is still
functioning but who have signs of the disease (raised transaminases [liver enzymes] and markers of
infection in the blood, such as viral RNA or antibodies against the virus). It can be used in patients
also infected with human immunodeficiency virus (HIV). The best way to use ViraferonPeg is with
ribavirin (an antiviral medicine). This combination is suitable for treatment-naïve patients (who have
not been treated before), as well as for patients who have previously responded to treatment.
ViraferonPeg can be used alone if the patient does not tolerate or should not take ribavirin.
The medicine can only be obtained with a prescription.
How is ViraferonPeg used?
ViraferonPeg treatment should be initiated and supervised by a doctor who has experience in the
management of patients with hepatitis C. ViraferonPeg is given once a week as a subcutaneous
injection (under the skin). It used on its own at a dose of 0.5 or 1 microgram per kilogram body weight
per week, or at a dose of 1.5 micrograms/kg/week when used with ribavirin. The duration of treatment
depends on the patient’s condition and response to treatment, and ranges from 24 weeks to a year. The
dose may need to be adjusted for patients who experience side effects. For full dosing information, see
the Summary of Product Characteristics (also part of the EPAR).
ViraferonPeg has to be stored in a refrigerator (2°C - 8°C).
How does ViraferonPeg work?
The active substance in ViraferonPeg, peginterferon alfa-2b, belongs to the group ‘interferons’.
Interferons are natural substances produced by the body to help it fight against attacks such as
infections caused by viruses. The exact way alpha interferons work in viral diseases in not fully
understood, but it is thought that they act as immunomodulators (substances that modify how the
immune system, the body’s defence system, works). Alpha interferons may also block the
multiplication of viruses.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: [email protected] http://www.emea.europa.eu EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Peginterferon alfa-2b is similar to interferon alfa-2b, which is already available in the European Union
(EU) as IntronA. In ViraferonPeg, the interferon alfa-2b has been ‘pegylated’ (coated with a chemical
called polyethylene glycol). This decreases the rate at which the substance is removed from the body
and allows the medicine to be given less often. The interferon alfa-2b in ViraferonPeg is produced by
a method known as ‘recombinant DNA technology’: the interferon alfa-2b is made by a bacterium that
has received a gene (DNA), which makes it able to produce it. The replacement acts in same way as
naturally produced interferon alpha.
How has ViraferonPeg been studied?
The use of ViraferonPeg alone in chronic hepatitis C has been studied in one study in 1,224 treatment-
naïve adult patients. ViraferonPeg used once a week for 48 weeks (at 0.5, 1 or 1.5 micrograms/kg) was
compared with interferon alfa-2b used at 3 million international units (IU) three times a week. The use
of ViraferonPeg with ribavirin has been studied over 48 weeks in 1,580 treatment-naïve patients. This
study compared two schedules of ViraferonPeg used with ribavirin with the combination of interferon
alfa-2b and ribavirin. An additional two studies have looked at the use of ViraferonPeg in combination
with ribavirin in 565 patients also infected with HIV.
The main measure of effectiveness was the level of hepatitis C virus RNA circulating in the blood
before and during treatment, and at ‘follow-up’, 24 weeks later.
What benefit has ViraferonPeg shown during the studies?
In the first study, ViraferonPeg was more effective than interferon alfa-2b. More patients had no
circulating viral RNA after 24 weeks of treatment with ViraferonPeg than with interferon alfa-2b:
46% with ViraferonPeg 1.5 microgram/kg/week compared with 24% with the comparator.
Combining ribavirin and ViraferonPeg (as a once-weekly injection of 1.5 micrograms/kg body weight)
was more effective than the combination with interferon alfa-2b (3 million IU three times a week):
more patients had responded to treatment at the end of the study (65% compared with 54%).
The combination of ViraferonPeg with ribavirin was also effective for the treatment of hepatitis C in
patients also infected with HIV.
What is the risk associated with ViraferonPeg?
The most common side effects with ViraferonPeg (generally reported in more than 1 patient in 10) are
weight loss, depression, irritability, insomnia (difficulty sleeping), headache, nausea (feeling sick),
anorexia (loss of appetite), diarrhoea, abdominal (tummy) pain, alopecia (hair loss), myalgia (muscle
pain), arthralgia (joint pain), musculoskeletal pain (pain in the muscles and bones), inflammation at
the site of the injection, fatigue (tiredness), rigors (shaking chills), fever, flu-like symptoms, asthenia
(weakness) and dizziness. For the full list of all side effects reported with ViraferonPeg, see the
Package Leaflet.
ViraferonPeg should not be used in people who may be hypersensitive (allergic) to any interferon or
any of the other ingredients. ViraferonPeg should not be used in:
• patients with a history of severe heart disease, • patients with severe medical conditions, • patients with an auto-immune disease (when the body attacks itself), • patients with severe liver problems, • patients with thyroid disease unless it is controlled, • patients with epilepsy or other central nervous system problems, • HIV-infected patients with signs of serious liver disease. In combination with ribavirin, ViraferonPeg should not be used in patients with kidney problems.
For a list of all restrictions with ViraferonPeg, see the Package Leaflet.
Why has ViraferonPeg been approved?
The Committee for Medicinal products for Human Use (CHMP) decided that ViraferonPeg’s benefits
are greater than its risks for the treatment of adult patients with chronic hepatitis C who have elevated
transaminases without liver decompensation and who are positive for serum hepatitis C virus (HCV)
RNA or anti-HCV including naïve patients with clinically stable HIV co-infection. The Committee
recommended that ViraferonPeg be given marketing authorisation.
Other information about ViraferonPeg:
The European Commission granted a marketing authorisation valid throughout the European Union
for ViraferonPeg to SP Europe on 29 May 2000. The marketing authorisation was renewed on 29 May
2005.
The full EPAR for ViraferonPeg is available here.
This summary was last updated in 06-2007.

Source: http://www.taintedblood.info/files/1193966238ViraferonPeg.pdf