Epivir (lamivudine)

How does it work?

Epivir tablets and oral solution contain the active ingredient lamivudine (also known as 3TC), which is a type of medicine called a nucleoside reverse transcriptase inhibitor. It is used in the treatment of HIV (human immunodeficiency virus) infection. (NB. In lower doses than those found in Epivir, lamivudine is used to treat chronic hepatitis B infection. See the Zeffix factsheet for more information on this use of lamivudine.)

AIDS (acquired immune deficiency syndrome) is caused by infection with HIV. This virus invades cells of the immune system, particularly the white blood cells known as CD4 T-helper lymphocytes. These cells normally work to activate other cells in the immune system to fight infection. Since HIV kills CD4 T-helper cells, over time the body becomes less able to fight the virus or subsequent infections.

Once the virus is inside the CD4 T-cell it multiplies. Part of the process of viral multiplication involves the conversion of the virus genetic material, RNA, into DNA. This is achieved by a compound essential to the virus, called reverse transcriptase. Reverse transcriptase is a compound known as an enzyme. Lamivudine works by blocking the action of this enzyme, thereby interfering with the conversion of viral RNA into DNA. This stops the virus from multiplying.

There is no cure for HIV, but lamivudine is one of a number of medications that lowers the amount of virus in the body (viral load) and slows the progression of the disease from HIV to AIDS. Lamivudine is used in conjunction with other anti-HIV drugs that attack the HIV virus in different ways. This helps prevent the virus becoming resistant to the medicine.

What is it used for?

HIV infection.

Warning!

The HIV virus is very good at becoming resistant to anti-HIV medicines. For this reason it is very important that you carefully follow your doctor's instructions for taking your anti-HIV medicines, in order to maintain effective levels of the medicines in your blood. If the blood levels drop, the virus will be given more chance to replicate and develop resistance to the drugs. Skipping even a few doses increases the risk of treatment failure, so you should try to ensure that you take all your doses at the correct time, and that you visit your doctor for repeat prescriptions before you run out.

Treatment of HIV infection with anti-HIV medicines such as this one does not reduce the risk of transmitting the virus to other people through sexual contact or blood contamination. You should continue to use condoms to prevent transmitting the virus to your sexual partner.

Combination antiretroviral therapy has been associated with a redistribution of body fat (lipodystrophy) in people with HIV. The long-term consequences of this are currently unknown, however your doctor may wish to monitor your body fat, and the levels of lipids (eg cholesterol) and sugar (glucose) in your blood, and may prescribe additional medicines for any lipid disorders that occur during treatment with this medicine. Contact your doctor if you notice any changes in your body fat during treatment with your HIV medicines.

Some people being treated with combination antiretroviral therapy may develop a bone condition called osteonecrosis. This condition is caused by loss of blood supply to a bone, causing death of the bone tissue. The risk of the condition is thought to be increased by corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, advanced HIV disease and long-term use of antiretroviral medicines. If you notice any joint stiffness, aches and pains (especially of the hip, knee and shoulder) or difficulty in movement while using this medicine, you should tell your doctor so this can be investigated.

If you have any problems with your liver you should have regular blood tests to monitor your liver function while you are taking this medicine. This is especially important if you have chronic hepatitis B or C.

If you suffer from chronic hepatitis B you should not stop taking this medicine without instructions from your doctor, as this may cause a recurrence of your hepatitis.

The class of medicines that lamivudine belongs to can cause a rare but serious condition called lactic acidosis, which is an excess of lactic acid in the blood, together with an enlarged liver. This side effect is more likely to occur in overweight women and people with liver disease (particularly hepatitis C treated with alpha interferon and ribavirin). If it occurs, lactic acidosis usually develops after a few months of treatment. Your doctor will monitor you for this side effect, but symptoms that might indicate it's development include rapid and/or deep breathing and non-specific symptoms such as feeling weak, sick or generally unwell, vomiting, abdominal pain, loss of appetite or weight loss. You should tell your doctor if you experience any of these.

Your doctor may also want you to have regular blood tests during treatment to check for a side effect called pancreatitis (inflammation of the pancreas). You should let your doctor know if you experience sudden unexplained stomach or abdominal pain, nausea or vomiting while taking this medicine, as these could be symptoms of pancreatitis.

Use with caution in

Decreased kidney function

Enlarged liver (hepatomegaly)

Liver disease

Hepatitis, especially chronic hepatitis B or C

History of alcohol abuse

Obese women.

Not to be used in

Allergy to any ingredient.

This medicine is not recommended for children under three months of age.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy. If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and Breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

The safety of this medicine in pregnancy has not been established. It should only be used during pregnancy if the expected benefit to the mother outweighs any potential risk to the developing foetus. It is not recommended in the first trimester. Seek medical advice from your doctor.

It is recommended that women infected with the HIV virus must not breastfeed their infants under any circumstances, in order to avoid transmission of the virus to the baby. Seek medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Headache

Difficulty in sleeping (insomnia)

Cough

Disturbances of the gut such as nausea, vomiting, diarrhoea or abdominal pain

Rash

Hair loss (alopecia)

Pain in the muscles and joints

Fatigue

General feeling of being unwell (malaise)

Fever (pyrexia)

Decrease in the number of a type of white blood cell (neutrophil) in the blood (neutropenia)

Low red blood cell count (anaemia)

Liver disorders

Inflammation of the pancreas (pancreatitis)

Disorder of the peripheral nerves causing weakness and numbness (peripheral neuropathy)

Elevated levels of lactic acid in the blood (lactic acidosis)

The side effects listed above may not include all of the side effects reported by the drug's manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

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