What is Victrelis - boceprevir?
Victrelis is a medicine that contains the active substance boceprevir, available as capsules (200 mg).
What is Victrelis used for - boceprevir?
Victrelis is indicated for the treatment of genotype 1 chronic (long-term) hepatitis C (a "liver infection due to the hepatitis C virus") in combination with two other medicines: peginterferon alfa and ribavirin.
Victrelis is for use in patients with compensated liver disease who have not previously been treated or who have not responded to previous therapy. Compensated liver disease occurs when the liver is damaged but functions normally.
The medicine can only be obtained with a prescription.
How is Victrelis used - boceprevir?
Victrelis treatment should be initiated and monitored by a physician experienced in the treatment of chronic hepatitis C.
The recommended dose is four capsules three times a day (for a total of 12 capsules a day). The medicine must be taken with meals (a meal or light snack). Administration without food may result in a loss of efficacy of the medicine.
Patients should take peginterferon alfa and ribavirin for four weeks and then supplement Victrelis therapy for no longer than 44 weeks; the duration of treatment depends on several factors such as the administration of previous therapy and the results of blood tests during the course of therapy.For further information on the use of Victrelis, including its use in combination with peginterferon alfa and ribavirin and duration of treatment, please refer to the Summary of Product Characteristics (included in the EPAR).
How does Victrelis - boceprevir work?
The active substance in Victrelis, boceprevir, is a protease inhibitor. It blocks an enzyme called HCV NS3 protease, which is found on the hepatitis C virus from genotype 1 and is involved in the duplication of the virus. If the enzyme is blocked, the virus is unable to reproduce normally and the rate of duplication it is slowed down, favoring the elimination of the virus.
How has Victrelis - boceprevir been studied?
The effects of Victrelis were first tested in experimental models before being studied in humans.
Two major studies were conducted involving 1,099 previously untreated subjects and 404 previously treated patients with chronic genotype 1 hepatitis C and compensated liver disease. In both studies Victrelis was compared with placebo (a substance with no effect on the body). All patients were treated simultaneously with peginterferon alfa and ribavirin. The main measure of effectiveness was the number of subjects in whom, at a distance 24 weeks after the end of the treatment, no trace of the viral infection remained on the blood test and could therefore be considered cured.
What benefit has Victrelis - boceprevir shown during the studies?
Victrelis has been shown to be effective in the treatment of patients with chronic genotype 1 hepatitis C in combination with peginterferon alfa and ribavirin therapy. In the study in previously treated patients, healing was seen in 66% of subjects who received Victrelis for 44 weeks (242 out of 366) compared with 38% of patients treated with placebo (137 out of 363).
In a second study, conducted in patients who had not responded to previous therapy, the cure rate was 67% (107 out of 161) of patients treated with Victrelis for 44 weeks compared with 21% (17 out of 80) of subjects who was given placebo.
Victrelis has also been shown to be effective in some patients whose treatment was stopped early as blood tests were shown to have recovered from the infection.
What is the risk associated with Victrelis - boceprevir?
Victrelis can induce more cases of anemia (decreased number of red blood cells) than treatment with peginterferon and ribavirin alone. The other more common side effects of Victrelis are fatigue, nausea, headache and dysgeusia (disturbance of the sense of taste). For the full list of side effects reported with Victrelis, see the Package Leaflet.
Victrelis must not be used in people who may be hypersensitive (allergic) to boceprevir or any of the other substances. It cannot be used in people with autoimmune hepatitis (a "hepatitis caused by an immune system disorder) or in pregnant women. Victrelis can slow down the metabolism of some medicines in the liver. These medicines can be harmful if they are present in a high percentage in the blood. therefore, it is important to avoid taking these medicines concomitantly with Victrelis. For a complete list of these medicinal products, see the Summary of Product Characteristics, also included in the EPAR.
Why has Victrelis - boceprevir been approved?
The CHMP noted that Victrelis, taken in combination with peginterferon alfa and ribavirin, results in a significant increase in the number of recoveries among patients with chronic hepatitis C. This result represents a significant improvement over the results obtained with peginterferon alfa and ribavirin alone therapy. The main increase in side effects with adding Victrelis to treatment was anemia. Despite this, the Committee decided that the medicine's benefits outweigh its risks and recommended that Victrelis be given a Marketing Authorization.
What measures are being taken to ensure the safe use of Victrelis - boceprevir?
The company that makes Victrelis will ensure that all doctors who can prescribe the medicine receive an information pack containing detailed information about the medicine, including information on the risk of anemia and other side effects.
Other information about Victrelis - boceprevir
On 18/07/2011 the European Commission issued a "marketing authorization" for Victrelis, valid throughout the European Union.
For more information about Victrelis therapy, please read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 06-2011.
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