Emtriva

emtricitabine

This 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 Emtriva?

Emtriva is a medicine containing the active substance emtricitabine. It is available as white and light blue capsules (200 mg) and as an oral solution (10 mg/ml).

What is Emtriva used for?

Emtriva is an antiviral medicine. It is used in combination with other antiviral medicines to treat adults and children infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).

For patients who have taken medicines to treat their HIV infection before and failed to respond to that treatment, doctors should only prescribe Emtriva once they have looked at the antiviral medicines the patient has taken before and assessed the likelihood of the virus’s response to any new antiviral medicines that might be prescribed.

The medicine can only be obtained with a prescription.

How is Emtriva used?

Treatment with Emtriva should be initiated by a doctor who has experience in the treatment of HIV infection. The recommended dose of Emtriva is one capsule once a day for patients who weigh 33 kg or more. The oral solution should be used by patients who weigh less than 33 kg, and by patients who cannot swallow the capsules. The dose of oral solution is 6 mg per kilogram body weight, up to a maximum of 240 mg (24 ml), taken once a day. The dose may need to be adjusted in patients who have problems with their kidneys. Emtriva can be taken with or without food. Because of limited information on safety and effectiveness in infants below four months of age, Emtriva is not recommended for use in this age group. For more information, see the Package Leaflet.

How does Emtriva work?

The active substance in Emtriva, emtricitabine, is a nucleoside reverse transcriptase inhibitor (NRTI). It blocks the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells and make more viruses. Emtriva, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level. Emtriva 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 Emtriva been studied?

Emtriva has been studied in three main studies including 1,498 HIV-infected adults. The first study compared Emtriva with stavudine (another antiviral medicine) in 571 treatment-naïve adults (who had not received treatment for their HIV infection before). Both medicines were taken in combination with didanosine and efavirenz (other antiviral medicines). The second study compared Emtriva with lamivudine (another antiviral medicine) in 468 treatment-naïve adults, in combination with stavudine and either efavirenz or nevirapine (other antiviral medicines). The third study included 459 patients who had been taking three antiviral medicines (including lamivudine) for at least 12 weeks and had low levels of HIV in their blood. The study compared the effects of replacing lamivudine with Emtriva, or remaining on the existing antiviral medicine combination. In all three studies, the main measure of effectiveness was the number of patients who had very low levels of HIV in their blood (viral load).

The effectiveness of Emtriva, in combination with other antiviral medicines, was also assessed in two studies including 120 HIV-infected patients aged between four months and 18 years.

What benefit has Emtriva shown during the studies?

Emtriva, in combination with other antiviral medicines, reduced viral loads in HIV-infected patients. In the first study of treatment-naïve adults, more patients taking Emtriva had viral loads below 50 copies/ml after 24 weeks of treatment than those taking stavudine (81% and 70%, respectively). This difference was maintained after 48 weeks of treatment (73% and 56%). In the second study, Emtriva was as effective as lamivudine: after 48 weeks, around two thirds of the patients had viral loads below 400 copies/ml, and slightly fewer had viral loads below 50 copies/ml. In treatment-experienced patients, the number of patients switching from lamivudine to Emtriva with viral loads below 400 copies/ml was similar to the number who continued taking lamivudine after 48 weeks (73% and 82%, respectively).

Similar results were seen in the two studies of children and adolescents taking Emtriva in combination with other antiviral medicines.

What is the risk associated with Emtriva?

The most common side effects with Emtriva (seen in more than 1 patient in 10) are headache, diarrhoea, nausea (feeling sick), and elevated creatine kinase levels in the blood (an enzyme found in muscles). Skin discoloration was very common in children. For the full list of all side effects reported with Emtriva, see the Package Leaflet.

Emtriva should not be used in people who may be hypersensitive (allergic) to emtricitabine or to any of the other ingredients.

As with other anti-HIV medicines, patients taking Emtriva may be at risk of lipodystrophy (changes in the distribution of body fat), osteonecrosis (death of bone tissue) or immune reactivation syndrome (symptoms of infection caused by the recovering immune system). Patients who have problems with their liver (including hepatitis B or C infection) may be at an elevated risk of liver damage when taking Emtriva. As with all other NRTIs, Emtriva may also cause lactic acidosis (a build-up of lactic acid in the body) and, in the babies of mothers taking Emtriva during pregnancy, mitochondrial dysfunction (damage to the energy-producing components within cells that can cause problems in the blood).

Why has Emtriva been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Emtriva’s benefits are greater than its risks for the treatment of HIV-1 infected adults and children in combination with other antiretroviral agents. The Committee noted that this indication is based on studies in patients who have not received HIV treatment before, or whose HIV is already well controlled with antiviral medicines, and that there was no experience of Emtriva in patients whose previous treatment for HIV was not working. The Committee recommended that Emtriva be given marketing authorisation.

Other information about Emtriva:

The European Commission granted a marketing authorisation valid throughout the European Union for Emtriva to Gilead Sciences International Limited on 24 October 2003. The marketing authorisation was renewed on 24 October 2008.

This EPAR was last updated on 01/08/2011 .

More detail is available in the summary of product characteristics

Product details

Publication details

Product information

27/07/2011  Emtriva -EMEA/H/C/000533 -WS/0115

Contents

• Annex I - Summary of product characteristics
• Annex IIA - Manufacturing-authorisation holder responsible for batch release
• Annex IIB - Conditions of the marketing authorisation
• Annex IIIA - Labelling
• Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

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Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Emtriva is indicated for the treatment of HIV-1 infected adults and children in combination with other antiretroviral agents.

This indication is based on studies in treatment-naive patients and treatment-experienced patients with stable virological control. There is no experience of the use of Emtriva in patients who are failing their current regimen or who have failed multiple regimens (see section 5.1).

When deciding on a new regimen for patients who have failed an antiretroviral regimen, careful consideration should be given to the patterns of mutations associated with different medicinal products and the treatment history of the individual patient. Where available, resistance testing may be appropriate.

Changes since initial authorisation of medicine

Initial marketing-authorisation documents