Victrelis - boceprevir

What is Victrelis - boceprevir?

Victrelis is a medicine that contains the active substance boceprevir, available as capsules (200 mg).

What is Victrelis - boceprevir used for?

Victrelis is indicated for the treatment of chronic (long-term) hepatitis C from genotype 1 (a liver infection due to hepatitis C virus) in combination with two other medicines: peginterferon alfa and ribavirin.

Victrelis should be used in patients with compensated liver disease who have not been treated previously 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 - boceprevir used?

Treatment with Victrelis should be started and monitored by a doctor 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 should be taken with meals (a meal or a light snack). Administration without food could result in a loss of efficacy of the medicine.

Patients should take peginterferon alfa and ribavirin for four weeks and then supplement the 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 therapy. For more information on the use of Victrelis, including the combination with peginterferon alfa and ribavirin and the duration of treatment, see the summary of product characteristics (also part of 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 not able to reproduce normally and the duplication rate 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 important studies were conducted, involving 1, 099 previously untreated subjects and 404 patients who had previously undergone treatment, with chronic genotype 1 hepatitis C and compensated liver disease. In both studies Victrelis was compared with a placebo (a substance that had no effect on the body). All patients were concomitantly treated with peginterferon alfa and ribavirin. The main measure of effectiveness was the number of subjects in which, after 24 weeks from 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 treating patients with chronic genotype 1 hepatitis C in combination with peginterferon alfa and ribavirin therapy. In the study of previously treated patients, healing was observed in 66% of subjects who received Victrelis for 44 weeks (242 out of 366) compared with 38% of placebo-treated patients (137 out of 363).

In a second study, conducted on patients who had not responded to previous therapy, the cure rate was 67% (107 of 161) of patients treated with Victrelis for 44 weeks compared with 21% (17 of 80) of subjects who had been given placebo.

Victrelis was also effective in some patients whose treatment was discontinued early as a result of infection with blood tests.

What is the risk associated with Victrelis - boceprevir?

Victrelis may induce more cases of anemia (decrease in the number of red blood cells in the blood) compared to treatment with peginterferon and ribavirin alone. The other most common side effects of Victrelis are fatigue, nausea, headache and dysgeusia (disturbance of the sense of taste). For the full list of all side effects reported with Victrelis, see the Package Leaflet.

Victrelis should not be used in people who may be hypersensitive (allergic) to boceprevir or any of the other ingredients. It cannot be used in people with autoimmune hepatitis (hepatitis caused by an immune system disorder) or in pregnant women. Victrelis can slow the metabolism of some medicines in the liver. These medicines can be harmful if present in high percentage in the blood; therefore, it is important to avoid concomitant intake of these medicines with Victrelis. For a complete list of these medicines, see the summary of product characteristics, also included with 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 chronic hepatitis C patients. This result represents a significant improvement over the results obtained with peginterferon alfa and ribavirin therapy alone. The main increase in side effects recorded with the addition of Victrelis to the treatment was anemia. Despite this, the Committee decided that the benefits of the medicine outweigh its risks and recommended that Victrelis be given 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 package containing detailed information on the medicine, including information on the risk of anemia and other side effects.

Other information on Victrelis - boceprevir

On 18/07/2011 the European Commission issued a marketing authorization for Victrelis, valid throughout the European Union.

For more information on Victrelis therapy, please read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Last update of this summary: 06-2011.