Tivicay

What is dolutegravir?

Dolutegravir is an antiretroviral medication used to treat human immunodeficiency virus (HIV). This medication is used in combination with other antiretroviral medications for HIV treatment or as an alternative HIV treatment regimen.

What is dolutegravir used to treat?

Dolutegravir is a prescription medication used to treat HIV type I infections in adults and children.

How does dolutegravir work?

Dolutegravir is an antiretroviral medication known as an integrase inhibitor. Dolutegravir prevents viral DNA from being incorporated into human DNA and prevents replication of the HIV virus in the body. 

If I am taking dolutegravir, can it harm my baby?

Dolutegravir is transferred across the placenta to reach the developing baby. The true risk of birth defects associated with this medication is unknown. While previous studies on dolutegravir exposure in pregnancy have failed to prove a link to birth defects, a preliminary analysis of data from an ongoing study in Botswana reported cases of brain and spinal cord birth defects in infants whose mothers took dolutegravir before conception or during the first trimester of pregnancy. The brain and spinal cord defects occurred in 4 out of 426 infants (0.9%); the incidence of these defects in infants born to women on other antiretroviral therapy was 0.1%. Continuing analysis of the same population found no increased risk of brain or spinal cord defects in women starting dolutegravir therapy during pregnancy. Another study of 101 HIV positive pregnant women reported suppression of the HIV virus with dolutegravir therapy after 20 weeks of pregnancy. The Antiretroviral Pregnancy Registry has not identified any link between dolutegravir use during pregnancy and an increased risk of birth defects.

While the Botswana study continues to collect data, the National Institutes of Health, the U.S. Food and Drug Administration, and the World Health Organization advise women on dolutegravir therapy who are of childbearing age to talk with their doctor about the risks associated with this medication and the need for effective contraception to prevent pregnancy. Women on dolutegravir therapy who desire to become pregnant should speak with their doctor to discuss other treatment options. Pregnant women taking dolutegravir should speak with their doctor before discontinuing dolutegravir therapy to avoid HIV transmission to the developing baby.

Some studies report a possible increase in risk of preterm delivery with antiretroviral use during pregnancy. If the medication is indicated in the mother, it should not be withheld due to concerns over preterm delivery. There is limited information available on incidence of stillbirth, low birth weight, and small size associated with antiretroviral therapy.

If I am taking dolutegravir and become pregnant, what should I do?

HIV positive women who want to conceive should talk to their doctor before conceiving. Women of childbearing age should have a negative pregnancy test before starting dolutegravir therapy and should use effective contraception throughout treatment with this medication. It is important to be in good health and on antiretroviral therapy that has decreased your viral load before pregnancy.

Women who become pregnant while taking antiretroviral therapy should continue therapy to prevent transmission of the virus to the developing baby. Continuous monitoring for adverse effects such as increased liver enzymes should be recommended throughout pregnancy. Women who are HIV positive and pregnant and who are not on antiretroviral therapy for their health should receive antiretroviral therapy to prevent transmission to the developing baby. Infants exposed to antiretroviral therapy should be monitored for long-term side effects. Antiretroviral regimens without dolutegravir are recommended during pregnancy due to the current lack of safety information related to this medication.

If I am taking dolutegravir, can I safely breastfeed my baby?

Dolutegravir is expected to pass into human breast milk. There is limited safety information on dolutegravir, so it is not a preferred antiretroviral medication in women who are nursing. In most developed countries, breastfeeding is not recommended in women with HIV because of the risk of spreading the virus to an infant through breastfeeding. In poorly developed countries, HIV positive mothers are more likely to continue breastfeeding their infants, with the infant receiving preventive antiretroviral therapy. The Centers for Disease Control and Prevention and the World Health Organization recommend not breastfeeding if you are an HIV positive women on antiretroviral therapy or preventative treatment.

If I am taking dolutegravir, will it be more difficult to get pregnant?

Animal studies have found that high doses of dolutegravir do not negatively affect fertility.

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If I am taking dolutegravir, what should I know?

Dolutegravir antiretroviral therapy has been associated with a possible increased risk of brain and spinal cord defects in babies exposed to the medication before conception and early in the first trimester of pregnancy. It is important to speak with your doctor to determine the best antiretroviral therapy during pregnancy. Breastfeeding is not recommended for women with HIV.

If I am taking any medication, what should I know?

This report provides a summary of available information about the use of dolutegravir during pregnancy and breastfeeding. Content is from the product label unless otherwise indicated.

You may find Pregistry's expert report about HIV here and reports about the individual medications used to treat HIV here.   Additional information can also be found in the resources below. 

For more information about dolutegravir during and after pregnancy, contact http://www.womenshealth.gov/ (800-994-9662 [TDD: 888-220-5446]) or check the following link:

Glaxo Smith Kline:  Tivicay Prescribing Information