What to Know About Triumeq (Abacavir, Dolutegravir, Lamivudine)

Triumeq is a once-daily, all-in-one tablet used to treat HIV in adults and older children. Licensed for use by the U.S. Food and Drug Administration (FDA) in August 2014, Triumeq is comprised of three different antiretroviral drugs:

• Abacavir, a nucleoside reverse transcriptase inhibitor (NRTI)
• Dolutegravir, an integrase inhibitor
• Lamivudine, another NRTI

Triumeq does not cure HIV. Instead, it suppresses the virus to undetectable levels so that the disease does not progress and the immune system remains intact. Triumeq does so by blocking two enzymes that HIV needs to replicate: reverse transcriptase and integrase.

Uses

Triumeq is used to treat HIV in adults and children who weigh at least 88 pounds (kilograms). Because the dosage cannot be modified, it cannot be used in those who weigh less than 88 pounds due to the risk of drug toxicity.

Triumeq can be used in people newly diagnosed with HIV as well as those who have been previously treated with other antiretroviral drugs.

In most people, Triumeq can be taken on its own with no other antiretroviral drugs. However, there are some people who may need an additional dose of dolutegravir to achieve an undetectable viral load (see "Modifications" below).

Before Taking

Before starting any antiretroviral therapy, your doctor will order tests to determine which drugs you are most sensitive to. This better ensures that the treatment you are prescribed is durable (longer-lasting) based on the characteristics of your virus.

Even if you are newly infected, it is possible to have picked up a drug-resistant virus that is less sensitive to certain HIV drugs. The same can occur in people who have experienced a treatment failure.

There are two tests that are commonly used to "profile" your virus so that the most effective HIV drugs are chosen:

• Genetic resistance testing, the preferred choice, is a blood test that identifies the type and number of mutations that confer resistance.
• Phenotypic testing is another blood test in which the virus is isolated and directly exposed to different antiretroviral drugs to see which ones work best.

Precautions and Contraindications

Triumeq is contraindicated for use in people with a known hypersensitivity to any of the antiretroviral drugs contained in Triumeq.

There are other conditions in which Triumeq is avoided or used with extreme caution:

• Hepatitis B: Triumeq is avoided in people co-infected with HIV and hepatitis B as doing so can cause the severe exacerbation of acute hepatitis B symptoms. A hepatitis B test is typically performed to ensure you don't have an undiagnosed infection.
• Hepatitis C: Some people co-infected with HIV and hepatitis C have also been known to experience liver failure as a result of dolutegravir exposure. If used, liver function tests must routinely be performed to monitor for toxicity. A hepatitis C test may also be recommended.
• Liver impairment: Triumeq is contraindicated for use in people with moderate or severe liver impairment, defined by a Child-Pugh score of 2 or 3, respectively.
• Kidney impairment: Triumeq can also impair kidney function. Due to the risk of acute kidney failure, the drug should not be used in people with a creatinine clearance is less than 50 milliliters per minute (mL/min).

Other Combination Antiretroviral Drugs

In addition to Triumeq, there are 12 other combination drugs that can be taken in a once-daily dose:

• Atripla (efavirenz + emtrictabine + tenofovir DF)
• Biktarvy (bictegravir + emtrictabine + tenofovir AF)
• Complera (FTC + rilpivirine + tenofovir DF)
• Delstrigo (doravirine + lamivudine + tenofovir DF)
• Dovato (dolutegravir + lamivudine)
• Genvoya (cobicistat + elvitegravir + emtrictabine + tenofovir AF)
• Juluca (dolutegravir + rilpivirine)
• Odefsey (emtricitabine + rilpivirine + tenofovir AF)
• Stribild (cobicistat + elvitegravir + emtricitabine + tenovofir DF)
• Symfi (efavirenz + lamivudine + tenofovir DF)
• Symfi Lo (efavirenz + lamivudine + tenofovir DF)
• Symtuza (cobicistat + darunavir + emtrictabine + tenofovir AF)

Dosage

Triumeq is formulated as a white oblong tablet, film-coated and embossed on one side with "572-Tri." Each tablet contains 600 milligrams (mg) of abacavir, 300 mg of lamivudine, and 50 mg of dolutegravir.

The recommended dosage of Triumeq is one pill daily, taken with or without food.

Modifications

There are certain drugs that can reduce the concentration of dolutegravir in the bloodstream. This includes:

• Sustiva (efavirenz)
• Aptivus (tipranavir)
• Tegretol (carbamazepine)
• Rifadin (rifampin)

If these drugs are used, an additional 50 mg of dolutegravir (in the form of Tivicay) would be taken 12 hours after the Triumeq dose.

How to Take and Store

Triumeq should be swallowed whole. Do not chew, crush, or split the tablet as this may affect drug absorption.

Triumeq can be stored safely at room temperature, ideally around 77°F (25°C). Keep the pills in their original light-resistant container in a dry, cool cabinet or drawer. Do not store on a sunny windowsill or in your glove compartment. Discard any expired pills.

Side Effects

Triumeq has relatively few side effects. Most are mild and transient, usually resolving on their own within a week or two. In rare instances, severe side effects may occur, requiring the discontinuation of therapy.

Common

The most common side effects associated with Triumeq are (by order of frequency):

• Insomnia (3% of users)
• Headache (2% of users)
• Fatigue (2% of users)
• Depression (1% of users)

Dizziness, nausea, diarrhea, abnormal dreams, and rash have also been known to occur, albeit less commonly (in fewer than 1% of users).

Severe

On rare occasions, Triumeq can trigger severe side effects, leading to potentially life-threatening complications such as:

• Hepatomegaly with steatosis, the abnormal enlargement of the liver, most commonly seen in people with pre-existing liver disease
• Hepatic decomposition, the acute deterioration of liver function leading to liver damage, most commonly seen in people with HIV and hepatitis C co-infection
• Lactic acidosis is the potentially life-threatening buildup of lactic acid in the bloodstream associated with many NRTIs, including abacavir
• Inflammatory reconstitution inflammatory syndrome (IRIS), a paradoxical reaction in which the initiation of therapy "unmasks" an undiagnosed infection or triggers an overreaction of the immune system
• Hepatitis B exacerbation, which can manifest with extreme fatigue, nausea, vomiting, abdominal swelling or pain, dark urine, or the yellowing of the eyes or skin (jaundice)

Arguably the most serious concern is abacavir hypersensitivity, which can develop spontaneously and sometimes become life-threatening. Severe cases can cause Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN).

The symptoms of abacavir hypersensitivity typically develop within hours of a dose. With each subsequent dose, the symptoms will almost invariably escalate.

Warnings and Interactions

Triumeq carries a black box warning advising consumers of the risk of abacavir hypersensitivity, hepatitis B exacerbation, hepatomegaly with steatosis, and lactic acidosis. Black box warnings are the highest level of alert from the FDA designed to call attention to serious drug risks.

Triumeq is a Pregnancy Category C drug, meaning that some of the drugs in the tablet have shown a potential for fetal harm in animal studies but that no well-controlled studies in humans are available. Although the benefits of Triumeq typically warrant the use of the drug during pregnancy, speak with your doctor to fully understand the risks.

Drug-Drug Interactions

Tikosyn (dofetilide), used in the treatment of arrhythmia (irregular heartbeat), is contraindicated for use with Triumeq. Speak with your doctor about substituting either Triumeq or Tikosyn if you require treatment for both conditions.

Other drugs are known to interact with Triumeq, either by interfering with therapeutic drug concentrations or increasing the risk of drug toxicity. Advise your doctor if you take any of the following before starting Triumeq:

• Anticonvulsants: Dilantin (phenytoin), Luminal (phenobarbital), Tegretol (carbamazepine), or Trileptal (oxcarbazepine)
• Glucophage (metformin)
• Tuberculosis drugs: Rifadin (rifampin), Rifater (rifampin + isoniazid + pyrazinamide), Rifamate (rifampin + isoniazid)
• St. John's wort

In addition, Triumeq should be taken two hours before or six hours after taking an aluminum- or magnesium-based antacid or laxative, iron supplement, calcium supplement, buffered medication, or Carafate (sucralfate)—each of which can affect Triumeq absorption in the gut.