What is CELSENTRI?
CELSENTRI is a drug containing the active ingredient maraviroc, available in color tablets
blue, oval (150 mg or 300 mg).
What is CELSENTRI used for?
CELSENTRI is an antiviral drug, indicated in combination with other antiviral medicines to treat adult patients who have an infection caused by human immunodeficiency virus type 1 (HIV-1), an AIDS-causing virus (syndrome of acquired immunodeficiency).
CELSENTRI is used only in patients previously treated for HIV infection and who have an infection caused only by the HIV-1 "CCR5-tropic" virus identified by blood test. This means that the virus, when attacking a cell, attaches itself to a specific protein present on the surface of the cell called CCR5.
The medicine can only be obtained with a prescription.
How is CELSENTRI used?
CELSENTRI therapy should be started by a doctor who has experience in the treatment of HIV infection. Before starting treatment with CELSENTRI the doctor must make sure that only an infection caused by the CCR5-tropic virus is present, using a sample of blood that has just been taken and a reliable test to define the tropism.
The recommended dose is 150, 300 or 600 mg twice a day, based on interactions with other medicines the patient is taking. CELSENTRI can be taken with or without food.
CELSENTRI should be used with caution in patients over the age of 65 and in subjects with liver disorders. In patients with kidney disorders it may be necessary to administer CELSENTRI less frequently if concomitant treatment with other medicinal products is being treated that are metabolized (disrupted) in the body in a similar way to CELSENTRI; the response to treatment must be carefully monitored in these subjects. For more information, see the Summary of Product Characteristics, which is also included with the EPAR. There is no data available on switching to CELSENTRI from another type of medicine to treat HIV infection in patients whose infection is effectively treated, if no virus can be detected in the blood. There is also no information on the efficacy of a new CELSENTRI therapy in patients who have taken the medicine in the past and in whom the therapy has stopped giving benefits. In these cases it is recommended to use other therapies.
How does CELSENTRI work?
The active substance in CELSENTRI, maraviroc, is a "CCR5 receptor antagonist". That is, it blocks a protein called CCR5, present on the surface of the cells of an organism affected by an HIV infection. The CCR5-tropic HIV virus uses this protein to penetrate cells. By attaching itself to the protein, maraviroc prevents the virus from infiltrating the cells. Maraviroc is ineffective if a blood sample virus attaches itself to another protein, called CXCR4, or if it is able to bind to both the CCR5 protein and the CXCR4 protein. Because HIV can only reproduce itself inside cells, CELSENTRI taken in combination with another antiviral drug reduces the amount of CCR5-tropic HIV in patients' blood, keeping 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.
What studies have been carried out on CELSENTRI?
The effects of CELSENTRI were first tested in experimental models before being studied in humans. CELSENTRI has been studied in two main studies involving a total of 1076 patients with CCR5-tropic HIV infection. Patients had been treated for at least six months with other therapies, which however had ceased to benefit. The efficacy of CELSENTRI taken once or twice a day was compared with that of placebo (a dummy treatment). All patients were also given an "optimized base therapy" (a combination of other antiviral drugs chosen for each patient based on the best chances of reducing HIV levels in the blood). The main measure of effectiveness was the changes in HIV levels in the blood (viral load) 24 weeks after treatment.
What benefit has CELSENTRI shown during the studies?
CELSENTRI was more effective than placebo in reducing viral loads when taken in combination with optimized background therapy. Considering the results of the two studies together, it was noted that viral loads had precipitated an average of 99% after 24 weeks of treatment in patients who had added CELSENTRI to an optimized baseline therapy compared to 90% of placebo-treated subjects. The percentage of patients in whom no HIV traces were found in the blood was approximately 45% when CELSENTRI was used as adjuvant therapy for optimized background therapy compared to 23% of patients treated with optimized background therapy alone. Similar results were also observed in subjects who continued treatment with CELSENTRI 300 mg twice a day for 48 weeks.
The two dosage regimens of CELSENTRI (taken once a day or twice a day) have been shown to have similar effects. However, the dose taken twice a day was found to be slightly more effective in patients at risk of a reduced response to HIV treatment due to high viral load, low immunity levels or poor treatment options available .
What is the risk associated with CELSENTRI?
The most common side effect with CELSENTRI (seen in more than 1 patient in 10) is nausea. For the full list of all side effects reported with CELSENTRI, see the Package Leaflet.
CELSENTRI should not be used in people who may be hypersensitive (allergic) to
maraviroc, peanut, soy or any of the other ingredients. As with other anti-HIV drugs, patients receiving CELSENTRI may also be at risk of immune reactivation syndrome (inflammatory signs and symptoms caused by reactivation of the immune system) or osteonecrosis (death of bone tissue). Patients with liver problems (including hepatitis B or C) may be at an increased risk of developing liver damage if treated with CELSENTRI.
Why has CELSENTRI been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that CELSENTRI's benefits, in combination with other antiretroviral medicines, outweigh its risks for the treatment of already treated adult patients who have a documented infection caused only by HIV. -1 CCR5-tropic. The Committee therefore recommended that the product be granted marketing authorization.
More information on CELSENTRI:
On 18 September 2007, the European Commission granted an authorization to Pfizer Limited
marketing authorization for CELSENTRI, valid throughout the European Union.
For the full version of the EPAR click here.
Last update of this summary: 08-2007