Triomune 30 Lamivudine, Stavudine and Nevirapine

Triomune general information

What is Triomune used for?

Triomune is a fixed dose combination treatment for Human Immunodeficiency Virus (HIV) infection in adults. Triomune tablets are used to treat HIV patients who have already been treated with other HIV medications and have responded well to each of the drugs in the combination; and are also able to tolerate each of these medications, at the recommended doses without requiring a dose adjustment due to low weight. HIV impairs the immune system by attacking specific immune cells called CD4+ cells that are involved in fighting infection, which can lead to opportunistic life-threatening infection (infections that would not normally be harmful); also if too many CD4+ cells are destroyed this can result in acquired immune deficiency syndrome (AIDS). Triomune tablets prevent or slow down the ability of HIV to replicate and spread, which keeps the amount of virus (viral load) down to a low level; allowing the numbers of CD4+ cells to increase, so that the immune system can recover, reducing the risk of disease progression. Triple drug therapy with Triomune 30 makes it easier to take the medications regularly, which helps improve compliance and helps prevent resistance of HIV to individual drugs.

How does Triomune work?

Triomune tablets contain a combination of 3 antiretroviral drugs stavudine, lamivudine and nevirapine, which are effective only against RNA viruses (retroviruses) like Human Immunodeficiency Virus (HIV). These three drugs each work by inhibiting the action of the viral-specific enzyme reverse transcriptase (RT) which is needed for the virus to be able to replicate. Retroviruses convert RNA to DNA, which is then integrated into the DNA of infected immune cells so that the virus can replicate. Nevirapine in Triomune tablets is a dipyridodiazepine derivative non-nucleoside reverse transcriptase inhibitor (NNRTI); nucleosides are the precursors to the building blocks of DNA and RNA. Nevirapine in Triomune tablets acts by binding to a specific site on the RT enzyme, the enzyme's active site known as the NNRTI pocket, disrupting the catalytic site of the enzyme, and blocking its action in a manner that is noncompetitive with nucleosides. Stavudine and lamivudine are both nucleoside analogue reverse transcriptase inhibitors (NRTI), which means that they block the action of RT by competing with one of the nucleosides needed to transcribe the viral RNA into DNA, becoming incorporated into the chain of newly synthesized viral DNA and preventing it from growing (chain termination). Stavudine is an analogue of thymidine and lamivudine is an analogue of cytidine. The combined action of the three antiiretroviral drugs in Triomune tablets prevents the integration of the virus into the DNA of the infected CD4+ immune cell by 2 different mechanisms, which inhibits the replication of HIV so that no more virus can be produced and this reduces the viral load (amount of virus). Triomune 30 slows down the replication of HIV within your body but does not kill the virus already incorporated in the CD4+ cells or prevent the spread of the infection to others.

What does Triomune contain?

Triomune tablets contain 3 active ingredient, the antiretrovirals stavudine (30mg), lamivudine (150mg) and nevirapine (200mg), used in combination to treat HIV infection.

Treating HIV infection with Triomune

Triomune tablets contain a combination of 3 antiretroviral drugs stavudine, lamivudine and nevirapine, which are effective only against RNA viruses (retroviruses) like Human Immunodeficiency Virus (HIV). HIV impairs the immune system by attacking specific immune cells called CD4+ cells that are involved in fighting infection, and this can lead to opportunistic life-threatening infection (infections that would not normally be harmful), including pneumonia, herpes virus infections, and Mycobacterium avium complex (MAC) infection. If too many CD4+ cells are destroyed this can result in acquired immune deficiency syndrome (AIDS). The three antiretroviral drugs in Triomune tablets each work by inhibiting the action of the viral-specific enzyme reverse transcriptase (RT), which is needed for the virus to be able to replicate, as it converts viral RNA to DNA, so that viral DNA can become integrated into the DNA of infected immune cells allowing the virus can replicate. Triomune 30 prevents the integration of HIV into the DNA of the infected CD4+ cell, which inhibits the replication of HIV so that no more virus can be produced and this reduces the viral load (amount of virus). Viraday tablets slow down the replication of HIV within your body but does not kill the virus already incorporated in the CD4+ cells or prevent the spread of the infection to others.

Triomune for HIV combination therapy

Triomune tablets contain a combination of 3 antiretroviral drugs stavudine, lamivudine and nevirapine, which are effective only against RNA viruses (retroviruses) like Human Immunodeficiency Virus (HIV) and inhibit the replication of HIV so that no more virus can be produced and this reduces the viral load (amount of virus). Triomune 30 is used to treat HIV patients who have already been treated with other HIV medications and have responded well to each of the drugs in the combination and are able to tolerate each of these medications, at the recommended doses without requiring a dose adjustment due to low weight. Triomune 30 is not intended for treating HIV patients who have not received treatment with nevirapine as this drug usually requires a test period at a lower dose to ensure that you do not have any reactions. The combined action of the three antiiretroviral drugs in Triomune tablets prevents the integration of the virus into the DNA of the infected CD4+ immune cell by 2 different mechanisms, which makes it harder for the virus to recover and become resistant to an individual drug. Triple drug therapy with Triomune 30 also makes it easier to take the medications regularly, which helps improve compliance and helps prevent HIV resistance developing.

What are the side effects of Triomune?

The most commonly reported side effects when taking Triomune tablets are related to the individual drugs in the fixed dose combination tablets and include:

• Stavudine: severe peripheral neuropathy, which is dose related and occurs more frequently in patients with advanced HIV infection or who have previously experienced peripheral neuropathy.
• Lamivudine: nausea, vomiting, headaches, abdominal pain and discomfort, peripheral neuropathy, arthralgias, myalgias, skin rash, pancreatitis
• Nevirapine: development of rash and liver toxicity; both could be potentially life threatening if severe and needs careful monitoring
A more serious but less common side effect is a condition called lactic acidosis which is excess lactic acid in the blood due to liver damage, which may cause pancreatitis, liver failure, or renal failure

What are the health risks when taking Triomune?

Lactic acidosis is a rare but potentially fatal condition that has been reported when taking an antiretroviral nucleoside analogue, such as in Triomune tablets. It is caused by a build up of excess of lactic acid in the blood due to liver damage, which is usually associated with hepatomegaly (liver enlargement) with steatosis (build up of fat in the liver) and may cause pancreatitis, liver failure, or renal failure. Symptoms begin within a few months of treatment and include: nausea, vomiting and abdominal pain, difficulty breathing, loss of appetite, weight loss, motor weakness.

When should Triomune not be used?

You should not use Triomune tablets if you:

• are allergic to stavudine, lamivudine or nevirapine or any ingredients in Triomune
• are pregnant or are breastfeeding
• have kidney or liver disease
• are just starting HIV therapy and have not used nevirapine previously
• have previously experienced peripheral neuropathy (damage to nerves in hands and feet causing tingling, numbness and pain)
• are taking medicines that interact with Triomune, including, the anticancer drugs doxorubicin and ribavirin, the antibiotics trimethoprim/sulfamethoxazole, rifampin for tuberculosis, other antiretrovirals like efavirenz, indinavir, lopinavir, nelfinavir and saquinavir, the antifungal ketoconazole, oral contraceptives, methadone

What medications interact with Triomune?

Several medications interact with Triomune tablets and should either not be taken while you are taking Triomune 30 or only after discussion and instruction from your doctor:

• Drugs that affect Triomune: the anticancer drugs doxorubicin and ribavirin, the antibiotics trimethoprim/sulfamethoxazole, rifampin for tuberculosis
• Drugs that are affected by Triomune: other antiretrovirals like efavirenz, indinavir, lopinavir, nelfinavir and saquinavir, the antifungal ketoconazole, oral contraceptives, methadone

How should Triomune be taken?

You should take your Triomune tablets with a glass of water twice daily. Since each tablet of Triomune contains half of the commonly prescribed daily doses of each of the 3 constituent drug, stavudine, lamivudine and nevirapine, you should not need to change the dose of Triomune 30. You should continue to take your Triomune 30 for as long as recommended by your doctor, and you will be monitored carefully to ensure that you do not develop any serious side effects, in which case your doctor will probably recommend that you stop taking your Triomune tablets.

How long should you take Triomune?

You should continue to take your Triomune 30 for as long as recommended by your doctor, and you will be monitored carefully to ensure that you do not develop any serious side effects, in which case your doctor will probably recommend that you stop taking your Triomune tablets.

Missed dose of Triomune

If you miss a dose of Triomune tablets take it as soon as you remember, unless it is time to take the next dose, then skip the missed dose. Do not take a double dose.

How should Triomune be stored?

You should store your Triomune below 25°C in a cool dry place.