Epivir

lamivudine

This is a summary of the European Public Assessment Report (EPAR) for Epivir. 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 Epivir.

What is Epivir?

Epivir is a medicine containing the active substance lamivudine. It is available as diamond-shaped tablets (white: 150 mg; grey: 300 mg) and as an oral solution (10 mg/ml).

What is Epivir used for?

Epivir is used in combination with other antiviral medicines to treat patients infected with human immunodeficiency virus (HIV), the virus that causes acquired immune deficiency syndrome (AIDS).

The medicine can only be obtained with a prescription.

How is Epivir used?

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

The recommended dose of Epivir for patients over 12 years of age is 300 mg a day. This can be given either once a day (two 150-mg tablets or one 300-mg tablet) or as one 150-mg tablet twice a day. In patients below 12 years of age, the number of tablets to take depends on their weight. Patients aged over three months who weigh less than 14 kg should be given the oral solution at a dose of 4 mg per kilogram body weight twice a day, up to a maximum of 300 mg per day.

Epivir tablets should ideally be swallowed without crushing. Patients who cannot swallow tablets should use the oral solution, or alternatively they may crush the tablets and add them to a small amount of food or drink immediately before swallowing it.

The dose of Epivir needs to be adjusted in patients who have severe problems with their kidneys. The oral solution can be used to achieve the appropriate dose. For more information, see the Package Leaflet.

How does Epivir work?

The active substance in Epivir, lamivudine, 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. Epivir, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level. Epivir 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 Epivir been studied?

Epivir has been studied in five main studies involving almost 3,000 adults (aged 18 years or over).

Four of these studies compared Epivir in combination with zidovudine (another antiviral medicine) to either Epivir or zidovudine alone, or to the combination of Epivir and zalcitabine (another antiviral medicine). The studies examined the effects of Epivir on the levels of HIV in the blood (viral load) and the number of CD4 T-cells in the blood (CD4 cell count). CD4 T-cells are white blood cells that are important in helping to fight infections, but which are killed by HIV.

The fifth study compared the effects of adding Epivir or placebo (a dummy treatment) to existing treatment for HIV infection in 1,895 adults who had been taking antiviral medicines for at least four weeks. This study looked at how many patients had developed an illness associated with AIDS or had died after a year’s treatment.

Epivir has also been studied in 615 patients aged between nine months and 15 years. The study compared the effects of Epivir taken with zidovudine to didanosine (another antiviral medicine) taken alone. The study measured how long the patients lived without their disease getting worse.

What benefit has Epivir shown during the studies?

All of the studies found that combinations including Epivir were more effective than the comparator medicines.

In the first four studies in adults, Epivir, taken in combination with zidovudine, increased CD4 cell counts more than the comparator medicines after 24 weeks of treatment. The combination also reduced viral loads in all studies after two to four weeks of treatment, but this effect was temporary.

In the fifth adult study, adding Epivir to existing treatment reduced the risk of disease progression or death: after a year, 9% of the patients taking Epivir had developed an AIDS-related illness or died (128 out of 1,369), compared with 20% of those taking placebo (95 out of 471).

Similar results were seen in HIV-infected patients aged under 15 years.

What is the risk associated with Epivir?

The most common side effects with Epivir (seen in between 1 and 10 patients in 100) are diarrhoea, nausea (feeling sick), vomiting, headache, insomnia (difficulty sleeping), cough, nasal symptoms, rash, muscle disorders, arthralgia (joint pain), alopecia (hair loss), fever, abdominal pain (stomach ache) or cramps, malaise (feeling unwell) and fatigue (tiredness). For the full list of all side effects reported with Epivir, see the Package Leaflet.

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

As with other anti-HIV medicines, patients taking Epivir 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 Epivir. As with all other NRTIs, Epivir may also cause lactic acidosis (a build-up of lactic acid in the body) and, in the babies of mothers taking Epivir during pregnancy, mitochondrial dysfunction (damage to the energy-producing components within cells that can cause problems in the blood).

Why has Epivir been approved?

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

Other information about Epivir:

The European Commission granted a marketing authorisation valid throughout the European Union for Epivir on 8 August 1996. The marketing authorisation holder is ViiV Healthcare UK Limited. The marketing authorisation is valid for an unlimited period.

This EPAR was last updated on 21/12/2011 .

More detail is available in the summary of product characteristics

Product details

Publication details

Product information

29/11/2011  Epivir -EMEA/H/C/000107 -IAIN/0077

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.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Epivir is indicated as part of antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infected adults and children.

Changes since initial authorisation of medicine

Initial marketing-authorisation documents