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Juluca, Tivicay, Triumeq (Dolutegravir)

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Dolutegravir – sold under the brand name Tivicay and included in the combination drugs Juluca and Triumeq – is used to treat HIV in children and adults.

The U.S. Food & Drug Administration (FDA) began reviewing dolutegravir in May 2018, after cases of neural tube birth defects involving the brain, spine, and spinal cord had been reported in babies born to women treated with Juluca, Tivicay or Triumeq.

What is Dolutegravir?

Dolutegravir is the third integrase inhibitor (INSTI) drug approved for the treatment of HIV-1 infection. When HIV infects a cell, it combines its genetic code into the cell’s own code. Dolutegravir blocks this integration. While HIV can still infect a cell, it is unable to copy itself.

The FDA approved Tivicay (dolutegravir) in 2013 to treat:

• HIV-infected adults who have never taken HIV therapy (treatment-naïve).
• HIV-infected adults who have previously taken HIV therapy (treatment-experienced), including those who have been treated with other integrase strand transfer inhibitors.
• children ages 12 years and older weighing at least 88 lbs. who are treatment-naïve or treatment-experienced but have not previously taken other integrase strand transfer inhibitors.

Triumeq received FDA clearance in 2014 and was the first dolutegravir-based fixed-dose combination to offer people living with HIV the option of a single-pill regimen that combines the INSTI dolutegravir, with the nucleoside reverse transcriptase inhibitors (NRTIs) abacavir and lamivudine. Triumeq is also approved for use in adults and children 12 years and older weighing at least 88 lbs.

In 2017, the FDA approved Juluca, a single-pill, 2-drug HIV treatment consisting of dolutegravir and rilpivirin. The drug is indicated for use in adults for the maintenance treatment of virologically suppressed HIV-1 infection.

Dolutegravir Side Effects

Before using a dolutegravir-containing medication, patients should tell their doctors if they have liver disease, especially hepatitis B or C.

Common dolutegravir side effects may include:

• Headache
• Tiredness
• Sleep problems (insomnia)

Patients should contact their doctor if they experience any of the falling while taking dolutegravir:

• First sign of a skin rash, no matter how mild.
• Liver problems, including nausea, vomiting, loss of appetite, upper stomach pain, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Because they alter the way the immune system works, dolutegravir-containing drugs like Tivicay, Triumeq and Juluca can increase a patient’s risk for certain infections or immune system disorders.

Patients should contact their doctors if they experience:

• Signs or symptoms of a new infection, including fever, night sweats, swollen glands, mouth sores, diarrhea, stomach pain, and weight loss.
• Chest pain (especially when breathing).
• Dry cough, wheezing, feeling short of breath.
• Cold sores, sores on the genital or anal area.
• Rapid heart rate.
• Feeling anxious or irritable.
• Weakness or prickly feeling.
• Problems with balance or eye movement.
• Trouble speaking or swallowing.
• Severe lower back pain.
• Loss of bladder or bowel control.
• Swelling in your neck or throat (enlarged thyroid).
• Menstrual changes.
• Loss of interest in sex.
• Impotence.

FDA Investigating Neural Tube Birth Defects Possibly Associated with Juluca, Tivicay, Triumeq (Dolutegravir)

In May 2018, the FDA alerted the public that serious cases of neural tube birth defects involving the brain, spine, and spinal cord have been reported in babies born to women who were treated with dolutegravir-containing drugs.

Preliminary results from an ongoing observational study in Botswana found that women who received dolutegravir when they became pregnant or early in the first trimester may be at higher risk for these defects.

“Ongoing monitoring will continue as part of the observational study in Botswana. Additional birth outcomes are projected from pregnant women who were exposed to dolutegravir at the time of becoming pregnant,” the FDA said. “We will conduct a comprehensive review of the results and any other data that becomes available. We will update the public with any new information. To monitor birth outcomes of pregnant women, report pregnancy exposures to the Antiretroviral Pregnancy Registry at 1-800-258-4263.”

Women should tell their doctor if they are pregnant or are planning to become pregnant before starting a dolutegravir-containing regimen.

Women of child-bearing age who take Juluca, Tivicay, or Triumeq should be sure to use an effective birth control method while undergoing treatment. These patients should also undergo a pregnancy test before beginning treatment.

For those who are already pregnant, stopping a dolutegravir-containing regimen without switching to an alternative HIV medicine could cause the amount of virus to increase and spread HIV to the baby.