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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/764501/2010

EMEA/H/C/000811

EPAR summary for the public

Celsentri

maraviroc

This is a summary of the European public assessment report (EPAR) for Celsentri. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Celsentri.

What is Celsentri?

Celsentri is a medicine that contains the active substance maraviroc. It is available as blue, oval tablets (150 or 300 mg).

What is Celsentri used for?

Celsentri is used to treat adults who are infected with human immunodeficiency virus type 1 (HIV 1), a virus that causes acquired immune deficiency syndrome (AIDS).

Celsentri is used in combination with other anti-HIV medicines, and only in patients who have been treated for HIV infection before and only when the HIV 1 they are infected with is 'CCR5-tropic', which is determined by a blood test. This means that the virus, when infecting a cell, attaches to a specific protein called CCR5 on the surface of the cell.

The medicine can only be obtained with a prescription.

How is Celsentri used?

Treatment with Celsentri should be started by a doctor who has experience in the management of HIV infection. Before treatment, the doctor must check that the patient's blood only shows infection with CCR5-tropic virus, using a newly drawn blood sample and a reliable 'tropism test'.

The recommended dose is 150, 300 or 600 mg twice a day, depending on the other medicines that the patient is taking. Patients who have kidney problems may need to take Celsentri less frequently if they

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are taking other medicines that are broken down in the body (metabolised) in the same way as Celsentri, and their response to treatment should be closely monitored. For more information, see the summary of product characteristics (also part of the EPAR).

There is no information on switching to Celsentri from another type of medicine for HIV infection in patients whose HIV is being treated successfully, when no virus can be detected in their blood. There is also no information on the re-use of Celsentri in patients who have taken it in the past, but in whom it stopped working. Other treatments should be considered in these cases.

How does Celsentri work?

The active substance in Celsentri, maraviroc, is a 'CCR5 antagonist'. It blocks a protein called CCR5, which is found on the surface of the cells in the body that HIV infects. The CCR5-tropic HIV uses this protein to enter the cells. By attaching itself to the protein, maraviroc prevents it from entering the cells. Maraviroc cannot work when the virus the patient is infected with, attaches to another protein called CXCR4 to enter the cells, or when it can attach to both CCR5 and CXCR4. As HIV can only reproduce itself within cells, Celsentri, taken in combination with other anti-HIV medicines, reduces the level of CCR5-tropic HIV in the blood of patients, and keeps it at a low level.

Celsentri does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.

How has Celsentri been studied?

Celsentri, taken once or twice a day, has been compared with placebo (a dummy treatment) in two main studies involving a total of 1,076 patients with CCR5-tropic HIV infection. The patients had previously taken other treatments for HIV for at least six months, but these had stopped working. The effects of Celsentri, taken once or twice a day, were compared with those of placebo (a dummy treatment). All of the patients also took 'optimised background therapy' (a combination of other antiHIV medicines chosen for each patient as it had the best chances of reducing the levels of HIV in the blood). The main measure of effectiveness was the reduction in the levels of HIV in the blood (viral load) after 24 weeks.

What benefit has Celsentri shown during the studies?

Celsentri was more effective than placebo in reducing viral loads, when taken in combination with optimised background therapy. Looking at the results of the two studies taken together, viral loads had fallen by an average of 99% after 24 weeks in the patients adding Celsentri to optimised background therapy, compared with 90% in those adding placebo. The proportion of patients who had undetectable levels of HIV in their blood was about 45% when Celsentri was added to optimised background therapy compared with 23% of the patients receiving optimised background therapy only. Similar results were also seen when looking at the patients who continued treatment with Celsentri 300 mg twice a day for 48 weeks.

The effects of once- and twice-daily doses of Celsentri were similar. However, the twice-daily dose was slightly more effective in patients who were at risk of a reduced response to HIV treatment, due to high viral load, low levels of immunity or few available treatment options.

What is the risk associated with Celsentri?

The most common side effects with Celsentri (seen in between one and 10 patient in 100) are nausea (feeling sick), diarrhoea, fatigue (tiredness) and headache. For the full list of all side effects reported with Celsentri, see the package leaflet.

Celsentri should not be used in patients who may be hypersensitive (allergic) to maraviroc, peanut, soya or any of the other ingredients.

Why has Celsentri been approved?

The CHMP decided that Celsentri's benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Celsentri

The European Commission granted a marketing authorisation valid throughout the European Union for Celsentri on 18 September 2007. The marketing authorisation holder is ViiV Healthcare UK Ltd. The marketing authorisation is valid for five years, after which it can be renewed.

The full EPAR for Celsentri can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. For more information about treatment with Celsentri, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 12-2010.

Celsentri

EMA/764501/2010

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