What are the long-term or serious side effects of Triumeq?

Key Points

• Liver toxicity and serious allergic reactions can result in long-term, dangerous or even fatal side effects with Triumeq (abacavir, dolutegravir, and lamivudine), a treatment for HIV-1 disease. Your doctor should monitor you for these side effects while you are taking Triumeq.
• Triumeq can lead to birth defects in an unborn baby. Tell your doctor if you are pregnant, or planning to get pregnant, before you start Triumeq treatment.
• Triumeq is usually well-tolerated. The most common side effects with Triumeq include trouble sleeping, headache, and tiredness, usually in less than 3 out of every 100 patients (3%). However, in the SINGLE study, these side effects persisted for at least 36 months in patients who had them.
• Other long-term or serious side effects may occur with Triumeq. Discuss side effects of any medication with your doctor.

Allergic reactions and Triumeq

If you have had any allergic (hypersensitivity) reaction with Triumeq you may need to stop therapy immediately. A delay in stopping treatment may result in death.

Table 1: If you get a symptom from 2 or more of the following groups in Table 1 while taking Triumeq, call your doctor right away to find out if you should stop taking Triumeq.

Following an allergic reaction to Triumeq, NEVER restart Triumeq (abacavir, dolutegravir and lamivudine) or any other product containing the medicines abacavir or dolutegravir. Taking Triumeq or abacavir again after having an allergic reaction may cause a very low blood pressure or a fatal reaction (death).

Your risk for an allergic, possibly fatal reaction to abacavir (a component of Triumeq) is much higher if you have a gene variation called HLA-B*5701.

• Your health care provider can determine with a blood test if you have this gene variation.
• You should not use Triumeq or any drug containing abacavir if you have a type of gene variation called the HLA-B*5701 allele.
• Allergic reactions are still possible even if your genetic test is negative, but the risk is much lower.

If you stop Triumeq for any other reason, even for a few days, and you are not allergic to Triumeq, talk with your health care provider before taking it again. You may still be at risk of a serious allergic reaction. If your doctor recommends that you restart Triumeq, be sure to start taking it again in the presence of a medical professional or someone who can call for medical help, if needed.

Liver toxicity and Triumeq

If you have moderate or severe liver disease you should not use Triumeq. Liver impairment can occur while taking Triumeq, even if you’ve never had liver disease before.

• It is important that your doctor monitors you for liver toxicity.
• Worsening liver disease can be serious and may lead to the need for a liver transplant or death.
• Your doctor can determine if you have liver impairment or any liver disease (such as hepatitis B or C) before you start treatment with Triumeq, and with ongoing blood tests.

If you have hepatitis B virus (HBV) infection and HIV-1 infection and stop taking Triumeq, you may have a flare-up (worsening) of your HBV. Your health care provider should monitor your liver function closely with blood tests for several months if you stop taking Triumeq. You may need to start a hepatitis B virus treatment.

Some HIV medicines, including Triumeq, can cause a rare, but serious condition called lactic acidosis with liver enlargement (hepatomegaly). Lactic acid can build up in your blood and can lead to death in the most serious cases.

Contact your doctor right away if you get any signs or symptoms of lactic acidosis:

• feel weak or tired
• unexpected muscle pain
• trouble breathing
• stomach pain with nausea and vomiting
• feel cold, especially in your arms and legs
• feel dizzy or lightheaded
• have a fast or irregular heartbeat

Dolutegravir, a component of Triumeq, has been reported to cause elevated liver enzymes, hepatitis, and acute liver failure, even in people without existing liver disease.

Alcohol consumption can also lead to liver disease. Before you start Triumeq, tell your health care provider if you drink alcohol or take medicines that contain alcohol.

Call you doctor right away if you develop any symptoms of liver disease such as:

• your skin or the white part of your eyes turns yellow (jaundice)
• dark or “tea-colored” urine
• light colored stools (bowel movements)
• loss of appetite
• nausea or vomiting
• pain, aching, or tenderness on the right side of your stomach area

Heart side effects and Triumeq

Some HIV-1 medicines including Triumeq may increase your risk of heart attack (also called a myocardial infarction).

Before you start treatment with Triumeq, tell your doctor if you smoke, have heart problems, or have risks for heart disease such as high blood pressure, high cholesterol, or diabetes.

Immune system reactions with Triumeq

When you start taking HIV-1 medicine your immune system becomes stronger and may fight infections hidden in your body. This is called Immune Reconstitution Syndrome. If you have new symptoms after starting treatment with Triumeq, tell your doctor right away.

Pregnancy and Triumeq

Tell your doctor before you are prescribed Triumeq if you are pregnant or plan to become pregnant. Your doctor may decide to prescribe a different medicine. One of the medicines in Triumeq called dolutegravir may harm your unborn baby.

If you are already taking Triumeq, and become pregnant, or think you might be pregnant, tell your doctor right away.

If you are able to get pregnant (of child-bearing potential), your doctor will perform a pregnancy test before you start treatment. Use an effective and reliable form of birth control consistently while you are taking Triumeq.

Breastfeeding and Triumeq

You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby. Do not breastfeed if you are taking Triumeq.

Two of the medicines in Triumeq (abacavir and lamivudine) can pass into your breastmilk.

Which medicines are in Triumeq?

Triumeq, from ViiV Health Care, contains three medicines in one oral tablet: dolutegravir, an integrase strand transfer inhibitor, and two nucleoside reverse transcriptase inhibitors - abacavir and lamivudine.

Triumeq can be used in both adults and children who weigh at least 40 kg (88 pounds) to treat Human Immunodeficiency Virus type 1 (HIV-1), the virus that causes acquired immunodeficiency syndrome (AIDS).

• The recommended dose of Triumeq is one tablet once a day with or without food.
• It’s best to take it at the same time each day, whether you take it in the day or at night.
• If you have kidney or liver disease, you may not be able to use Triumeq. Discuss this with your doctor.
• Be sure to get your refills for Triumeq on time. The HIV-1 virus may increase and become harder to treat (become resistant) if you miss any doses.

For many people, Triumeq can be used as the only tablet they will need to take each day for HIV-1 treatment. This treatment can help you reach and maintain an undetectable level of virus in your blood, although individual results may vary.

Triumeq is not for use by itself in people who have, or have had, resistance to abacavir, dolutegravir, or lamivudine.

Bottom Line

• Triumeq can cause some serious and possibly long-term side effects. Problems with an allergic reaction (which can lead to death), liver toxicity, lactic acidosis or birth defects in pregnancy, are some of the more serious issues you need to consider.
• Talk to your health care provider to learn about other side effects that can occur with Triumeq, and to determine if this treatment is right for you.
• Overall, Triumeq is well-tolerated by patients for HIV-1 treatment. The most common side effects include trouble sleeping (insomnia), headache, and tiredness. In a few people, these side effects may be long-term.