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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/369723/2010

EMEA/H/C/000534

EPAR summary for the public

Telzir

fosamprenavir

This document is a summary of the European public assessment report (EPAR) for Telzir. 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 Telzir.

What is Telzir?

Telzir is a medicine that contains the active substance fosamprenavir. It is available as pink, capsuleshaped tablets (700 mg) and as an oral suspension (50 mg/ml).

What is Telzir used for?

Telzir is used in combination with ritonavir and other antiviral medicines to treat patients aged six years or above who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS). Doctors should prescribe Telzir to patients who have already taken medicines belonging to the same class as Telzir (protease inhibitors) only after they have looked at the antiviral medicines the patient has taken before and considered the likelihood that the virus will respond to the medicine.

The medicine can only be obtained with a prescription.

How is Telzir used?

Treatment with Telzir should be started by a doctor who has experience in the management of HIV infection.

The recommended dose of Telzir for adults (aged 18 years or over) and for patients aged between six and 18 years who weigh more than 39 kg is 700 mg twice a day. In patients aged between six and 18

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years who weigh between 25 and 39 kg, the dose depends on body weight. There is no recommended dose for patients below 18 years who weigh less than 25 kg.

Telzir tablets can be taken with or without food. The oral suspension should be taken without food on an empty stomach in adults, but in younger patients it should be taken with food in order to hide the taste and help them stick to treatment. In adults, each dose of Telzir must be given with 100 mg ritonavir, twice a day. In younger patients, the dose of ritonavir depends on body weight.

Adults with liver problems should take a reduced dose of Telzir and be closely monitored for safety and their response to treatment. For more information, see the package leaflet.

How does Telzir work?

The active substance in Telzir, fosamprenavir, is a 'prodrug' of the protease inhibitor amprenavir, which means that it is converted into amprenavir in the body. Amprenavir has been authorised in the European Union (EU) since October 2000 as Agenerase. Amprenavir blocks an enzyme called protease, which is involved in the reproduction of HIV. When the enzyme is blocked, the virus does not reproduce normally, slowing down the spread of infection.

Ritonavir is another protease inhibitor that is used as a 'booster'. It slows down the rate at which amprenavir is broken down, increasing the levels of amprenavir in the blood. This allows a lower dose of Telzir to be used for the same antiviral effect. Telzir, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level. Telzir 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 Telzir been studied?

Telzir has been studied in three main studies involving 1,862 adults infected with HIV. The first compared ritonavir-boosted Telzir with nelfinavir (another protease inhibitor) in treatment-naive adults (who had previously taken treatment for HIV infection for no longer than four weeks). The other two studies compared Telzir with lopinavir (another protease inhibitor), both of which were boosted with ritonavir. In one of these studies, the patients were treatment-naive, but in the other study, they had taken HIV treatment including protease inhibitors before. In all three studies, the patients also took two reverse transcriptase inhibitors (another type of antiviral medicine). The main measure of effectiveness was the level of HIV in the blood (viral load) in the first 48 weeks of treatment.

Telzir, taken in combination with other antiviral medicines, has also been assessed in one main study including 57 HIV-infected patients aged between two and 18 years.

What benefit has Telzir shown during the studies?

In the studies of treatment-naive adults, ritonavir-boosted Telzir was as effective as the comparator medicines, but it was less effective in adults who had been treated before. After 48 weeks, 69% of the treatment-naive adults taking ritonavir-boosted Telzir (221 out of 322) and 68% of those taking nelfinavir (221 out of 327) had viral loads below 400 copies/ml. Similar results were seen in the study comparing Telzir with lopinavir, with around three-quarters of both groups of patients having viral loads below 400 copies/ml. In the study of patients who had been treated before, the patients taking lopinavir had larger reductions in viral loads over the first 48 weeks.

A similar benefit has also been seen in younger patients receiving Telzir. However, there were too few patients aged below six years to support the use of Telzir in this age group.

What is the risk associated with Telzir?

The most common side effects in adults taking Telzir (seen in more than 1 patient in 10) are diarrhoea and increases in the levels of triglycerides (a type of fat) in the blood. Similar side effects are seen in younger patients. For the full list of all side effects reported with Telzir, see the package leaflet.

Telzir should not be used in people who may be hypersensitive (allergic) to fosamprenavir, amprenavir, any of the other ingredients, or ritonavir. Telzir must not be used in patients who are taking rifampicin (used to treat tuberculosis), St John's wort (a herbal preparation used to treat depression), or medicines that are broken down in the same way as Telzir or ritonavir and are harmful at high levels in the blood. See the package leaflet for the full list of these medicines. As Telzir is converted into amprenavir in the body, it must not be given at the same time as other medicines containing amprenavir.

As with other anti-HIV medicines, patients taking Telzir 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 Telzir.

Why has Telzir been approved?

The CHMP concluded that Telzir, which contains a prodrug of amprenavir, provides an advantage for patients, as the number of tablets they need to take is reduced when compared to the number of Agenerase capsules that they would need to take for the same dose of amprenavir. Although the Committee noted that the use of ritonavir-boosted Telzir had not been studied sufficiently in heavily pretreated patients and that no comparative studies had been carried out in children, it decided that Telzir's benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Telzir:

The European Commission granted a marketing authorisation valid throughout the EU for Telzir on 12 July 2004. The marketing authorisation holder is ViiV Healthcare UK Limited. The marketing authorisation is valid for an unlimited period.

The full EPAR for Telzir can be found here. For more information about treatment with Telzir, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 06-2010.

Telzir

EMA/369723/2010

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