Triumeq

Generic name: abacavir, dolutegravir, and lamivudine (a BAK a vir, DOE loo TEG ra vir, la MIV ue deen)
Brand name: Triumeq
Drug class: Antiviral combinations

Triumeq contain a combination of abacavir, dolutegravir, and lamivudine. Abacavir, dolutegravir, and lamivudine are antiviral medications that prevent human immunodeficiency virus (HIV) from multiplying in your body.

Triumeq is used to treat human immunodeficiency virus (HIV), the virus that can cause acquired immunodeficiency syndrome (AIDS). This medicine is not a cure for HIV or AIDS.

Triumeq is for use in adults and children who weigh at least 88 pounds (40 kilograms).

Warnings

You should not take Triumeq if you have ever had an allergic reaction to any medicine that contains abacavir, or if you have a gene variation called HLA-B*5701 allele. Also, you should not use this medicine if you have moderate or severe liver disease, or if you are also taking dofetilide (Tikosyn).

Stop using Triumeq and call your doctor at once if you have any of these signs of an allergic reaction to this medicine: fever; rash; nausea, vomiting, diarrhea, stomach pain; general ill feeling, extreme tiredness, body aches; shortness of breath, cough, sore throat.

If you've ever had hepatitis B, it may become active or get worse after you stop using Triumeq. You may need frequent liver function tests for several months.

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. Call your doctor or get emergency medical help if you have unusual muscle pain, trouble breathing, stomach pain, dizziness, feeling cold, or feeling very weak or tired.

Before taking this medicine

You should not use Triumeq if you are allergic to abacavir, dolutegravir, or lamivudine, or if:

• you also take dofetilide (Tikosyn);
• you have moderate or severe liver disease;
• you have a gene variation called HLA-B*5701 allele (your doctor will test you for this); or
• you have a history of allergic reaction to Combivir, Dutrebis, Epivir, Epzicom, Tivicay, Trizivir, or Ziagen.

To make sure Triumeq is safe for you, tell your doctor if you have:

• liver disease (especially hepatitis B or C);
• heart problems or risk factors such as diabetes, smoking, high blood pressure, high cholesterol; or
• kidney disease.

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. This may be more likely if you have other medical conditions, if you are overweight, or if you are a woman. Ask your doctor about your risk.

You may need to have a negative pregnancy test before starting this treatment.

Abacavir, dolutegravir, or lamivudine could harm an unborn baby if you take this medicine at the time of conception or during the first 12 weeks of pregnancy. Use effective birth control to prevent pregnancy, and tell your doctor if you become pregnant.

If you are pregnant, use your medications properly to control your infection. HIV can be passed to your baby if the virus is not controlled during pregnancy. Your name may be listed on a registry to track any effects of antiviral medicine on the baby.

Women with HIV or AIDS should not breast feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

How should I take Triumeq?

Take Triumeq exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

You may take Triumeq with or without food.

Triumeq comes with a Medication Guide and a Warning Card listing symptoms of an allergic reaction. Read this information and learn what symptoms to watch for. Keep the Wallet Card with you at all times.

You may need to take an extra daily dose of dolutegravir (Tivicay) if you take Triumeq with certain other medicines.

Use all HIV medications as directed and read all medication guides you receive. Do not change your dose or stop using a medicine without your doctor's advice. Every person with HIV should remain under the care of a doctor.

Store at room temperature away from moisture and heat. Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative.

If you've ever had hepatitis B, this virus may become active or get worse in the months after you stop using Triumeq. You may need frequent liver function tests while using this medicine and for several months after your last dose.

Dosing information

Usual Adult Dose for HIV Infection:

1 tablet orally once a day

Use: For the treatment of HIV-1 infection

Usual Pediatric Dose for HIV Infection:

At least 40 kg: 1 tablet orally once a day

Use: For the treatment of HIV-1 infection

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely. If you miss several doses, you may have a dangerous or even fatal allergic reaction once you start taking this medication again.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Triumeq?

Using Triumeq will not prevent your disease from spreading. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Triumeq side effects

Call your doctor at once if you have symptoms of an allergic reaction from two or more of these specific side effect groups:

• Group 1 - fever;
• Group 2 - rash;
• Group 3 - nausea, vomiting, diarrhea, stomach pain;
• Group 4 - general ill feeling, extreme tiredness, body aches;
• Group 5 - shortness of breath, cough, sore throat.

Once you have had an allergic reaction to a medicine that contains abacavir or dolutegravir, you must never use it again. If you stop taking Triumeq for any reason, talk to your doctor before you start taking it again.

Call your doctor at once if you have:

• other signs of allergic reaction - skin blisters or peeling, eye redness, swelling in your face or throat, trouble breathing;
• lactic acidosis - unusual muscle pain, trouble breathing, stomach pain, vomiting, irregular heart rate, dizziness, feeling cold, or feeling very weak or tired; or
• liver problems - swelling around your midsection, right-sided upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Triumeq affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). Tell your doctor if you have:

• signs of a new infection - fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;
• trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or
• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common Triumeq side effects may include:

• headache;
• tiredness; or
• trouble sleeping.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Triumeq?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Some medicines can make Triumeq much less effective when taken at the same time. If you take any of the following medicines, take your Triumeq dose 2 hours before or 6 hours after you take the other medicine.

• antacids or laxatives that contain aluminum or magnesium (Maalox, Milk of Magnesia, Mylanta, Pepcid Complete, Rolaids, and others);
• the ulcer medicine sucralfate (Carafate);
• buffered medicine; or
• vitamin or mineral supplements that contain calcium or iron (can be taken at the same time with Triumeq if you take with food).

Many drugs can interact with abacavir, dolutegravir, and lamivudine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Does Triumeq cause erectile dysfunction?

Triumeq is unlikely to cause erectile dysfunction (ED), and ED is not listed as a side effect in the product information nor reported in post-marketing data – these are studies done after a drug has been approved. A review concluded that newer HIV combination treatments in use today have no clear-cut association with ED. Older HIV agents, such as zalcitabine (no longer in use) and enfuvirtide (rarely used) were known to cause ED. Using abacavir and raltegravir together had a weak association with ED, but no protease inhibitors appear to increase the risk. Triumeq contains three antivirals: abacavir and lamivudine (both nucleoside analogs), and dolutegravir (an integrase inhibitor).

ED is unusually common among men with HIV, regardless of what medication they are on, and in one study 25% reported experiencing ED often or sometimes during the preceding 6 months. Other research has indicated around 40 to 60% of men with HIV may have some form of ED. ED is more likely to occur in older patients, those who have had HIV for several years, a lower CD4 count when first diagnosed, or who have depression or diabetes.

ED has many different physical and psychological causes and may be associated with cardiovascular disease, diabetes, high cholesterol, low testosterone levels, smoking, obesity, alcohol and drug use, anxiety, or depression. If you develop ED and you have HIV, see your doctor for a thorough assessment, that includes an investigation of your cardiovascular and mental health. Lose weight if you are overweight, exercise regularly, limit alcohol intake, and don’t smoke.

Triumeq is a fixed-dose combination tablet that contains three antivirals: abacavir, dolutegravir, and lamivudine, which may be used to treat human immunodeficiency virus type 1 (HIV-1) infection in adults and children weighing at least 40 kg (88 pounds).

Can Triumeq be used for PrEP?

• Triumeq (dolutegravir, abacavir and lamivudine) is not approved to be used for HIV-1 pre-exposure prophylaxis (PrEP). Triumeq is used to treat (not prevent) HIV-1, the virus that causes acquired immunodeficiency syndrome (AIDS).
• The medications FDA-approved for PrEP are either Truvada (tenofovir disoproxil fumarate and emtricitabine) or Descovy (emtricitabine and tenofovir alafenamide).
• For many people who need treatment for HIV-1, Triumeq can be used as the only tablet they will need to take each day.

How is Triumeq used in HIV treatment?

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 HIV-1 infection. 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.

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. Undetectable means that you have less than 50 copies of HIV-1 RNA in a milliliter (mL) of blood.

However, if you have resistance to any of the three drugs found in Triumeq (dolutegravir, abacavir and lamivudine), it should be used in combination with other HIV medications.

You should not use Triumeq if you have a type of gene variation called the HLA-B*5701 allele.

• Your doctor will order this genetic screening test for you. Patients with this gene variation are at greater risk for serious, possibly fatal allergic reactions with the use of abacavir, one of the drugs found in Triumeq.
• If you’ve had an allergic reaction to abacavir, or are positive for the HLA-B*5701 allele, you should not use Triumeq or any drug containing abacavir.
• If your genetic test is negative, you still might have an allergic reaction but the risk is much lower.
• However, if you do have an allergic reaction while receiving Triumeq, do not use Triumeq or other medicines containing abacavir or dolutegravir ever again.
• The most common side effects with Triumeq include trouble sleeping, headache, and tiredness 

Take Triumeq at least 2 hours before or 6 hours after you take any medicines that contain aluminum, magnesium, or buffered medicines such as antacids and laxatives.

Iron or calcium supplements can also lead to a drug interaction with Triumeq.

• If you take Triumeq with food, you can take these iron or calcium supplements at the same time as you take your Triumeq.
• If you take your Triumeq without food, you should take Triumeq at least 2 hours before or 6 hours after you take these supplements.

Do not take Triumeq if you take dofetilide (Tikosyn), a medicine used in people with certain heart rhythm disorders (known as arrhythmias). Also, do not take Triumeq with dalfampridine (Ampyra). Taking Triumeq with these drugs can cause serious side effects that may be serious or life-threatening. Do not stop using any medications, including Triumeq, without first talking to your doctor. If you are not sure if you are taking these medications, ask your doctor or pharmacist.

If you have heart disease, kidney or liver disease be sure to tell your doctor. Also, let your doctor know if you are pregnant or plan to become pregnant. This medication could harm an unborn baby.

How well does Triumeq work to treat HIV?

In the SINGLE clinical trial of Triumeq, 833 adults with HIV-1 who had never used HIV-1 treatment before were evaluated. Triumeq was compared to Atripla (efavirenz, emtricitabine, and tenofovir), another medicine used to treat HIV-1 infection.

Overall, more patients were found to reach undetectable levels of HIV-1 RNA at about three years compared to Atripla. The difference was mainly due to more patients on Atripla stopping their medicine because of side effects than patients on Triumeq.

SINGLE Study: Triumeq Compared to Atripla at 144 Weeks

Triumeq	Atripla
*CD4+ T-cells (also called T-cells) are white blood cells that help fight infections; table adapted from manufacturer data.
71% of patients who took Triumeq reached undetectable levels.	63% of patients who took Triumeq reached undetectable levels.
The average increase in CD4+ T-cell* count was 378 cells/mm3.	The average increase in CD4+ T-cell* count was 332 cells/mm3.
4% of patients dropped out of the study due to side effects.	4% of patients dropped out of the study due to side effects.

The most common medium to severe side effects of Triumeq (in at least 2% of patients) when compared to Atripla treatment were found to be similar for each group.

SINGLE Study: Triumeq Side Effects at 144 Weeks

Side Effect	Triumeq	Atripla
Trouble Sleeping	3%	3%
Headaches	2%	2%
Tiredness	2%	2%

Bottom Line

• Triumeq is used to treat someone living with an HIV-1 infection. It is not used to prevent HIV-1 infection. Many patients can reach an undetectable level of virus in their blood with Triumeq.
• This medication is taken once a day at the same time each day, with or without food.
• Triumeq is well-tolerated. The most common side effects with Triumeq include trouble sleeping, headache, and tiredness, and occur in 3% or less of patients.

This is not all the information you need to know about Triumeq for safe use. Review the full information here, and speak to your health care provider if you have questions or concerns.