Dolutegravir (Tivicay®)

Last Update: 01 Jun 2026

Table of content

1. What Is It? 2. Risks 3. Benefits 4. Lactation 5. Key Takeaways 6. Research limits

Welcome to our Fact Sheet on dolutegravir during pregnancy and lactation. The information given is based on current research and may be updated with new scientific knowledge. This information does not replace personalized advice from healthcare professionals.

The Healthy Pregnancy Hub collaborates with the expertise of the CIHR Pan-Canadian Network for HIV and STBBI Clinical Trials (CTN+) in developing this information sheet.

CTN+ plays a central role in Canada’s response to HIV and other sexually transmitted and blood-borne infections (STBBIs). Through high-quality research conducted in partnership with communities, the network helps develop evidence-based solutions for people and regions affected by these infections.

1. What is dolutegravir?

Dolutegravir (Tivicay®) is a medication used in combination with other medications to treat human immunodeficiency virus (HIV). Dolutegravir comes as tablets for adults, and a dissolvable form for babies and young children. Your healthcare team will work with you to choose the right form and dose for you.

Dolutegravir belongs to a group of HIV medications called integrase inhibitors (INSTIs). These medications block an important step the virus needs to make more copies of itself. This helps lower the amount of virus in your body.

Dolutegravir is usually taken together with one or two other HIV medications, as part of antiretroviral therapy (ART). When taken as prescribed, ART can lower the virus to very low levels, sometimes becoming undetectable. This is very important, especially during pregnancy, because it helps keeping you healthy and it greatly reduces the chance of passing HIV to your baby during pregnancy, birth, or feeding.

If you’re pregnant or planning a pregnancy, it’s important to talk to your healthcare provider before starting, stopping, or changing any HIV medication. Stopping treatment can increase the amount of virus in your body and increase the risk of passing HIV to your baby. Planning, when possible, can help your healthcare team review the risks and benefits and adjust your treatment safely if needed.

Tip: Some supplements and foods that contain iron or calcium (including many prenatal vitamins) can affect how well dolutegravir is absorbed. To help your medication work properly, it is recommended to take dolutegravir at least 2 hours before or 6 hours after taking food and supplements with iron or calcium. Ask your healthcare provider or pharmacist about the best timing for your medication and prenatal vitamins.

2. What are the risks of dolutegravir during pregnancy?

There’s no perfectly risk-free option when it comes to medication during pregnancy. If you are pregnant or planning a pregnancy, talk to your healthcare provider before starting, stopping, or changing any medication, including dolutegravir.

Dolutegravir is part of a first-line treatment for people living with HIV who are pregnant or planning a pregnancy. As with any medication, it’s important to talk to your healthcare team before making changes. They can help you balance the benefits of controlling HIV with any possible risks for you and your baby.

Understanding risks during pregnancy

Every pregnancy starts with some risks. Problems like miscarriage (loss of the baby), birth defects (malformations present at birth), or premature birth (before 37 weeks) can happen in any pregnancy for many reasons. This is called the background risk. Research helps us understand whether a medication like dolutegravir may change these risks. Most studies compare people taking dolutegravir with those taking other HIV treatments or with people without HIV. Here are some of the main findings so far:

Studies on dolutegravir safety in pregnancy are reassuring, they do not show a higher chance of birth defects with dolutegravir.
Early studies raised concerns neural tube defects (birth defects affecting the baby’s brain or spine) when dolutegravir was taken at conception. However, the update from this study and newer studies shows this risk is very low and similar to other HIV treatments.
Large studies do not show an increased risk of problems like preterm birth or babies being smaller than expected.
Few studies found that people taking dolutegravir may gain more weight during pregnancy. However, it is still unclear how this affects pregnancy outcomes. More research is needed.

The table 1 summarises what research has found so far. But one or two studies is not enough to confirm a risk. Many other factors like age, genetics, lifestyle, and health conditions can also play a role. If you have any concerns, talk to your healthcare professional who will help you make the best decision for you and your baby.

Table 1. Possible risks associated with taking dolutegravir during pregnancy.

Who?	What?	What does research say?
Pregnant person	Fertility (ability to get pregnant)	No studies have been done in humans. In animal studies, dolutegravir did not affect fertility, even at much higher doses. More research is needed to confirm.
	Miscarriages	Some studies suggest miscarriage may be more common in people living with HIV on treatment compared to people without HIV. It is not clear if this is linked to dolutegravir. More research is needed.
	Weight gain	Some studies found more weight gain with dolutegravir during pregnancy. It is not clear how this affects pregnancy outcomes. More research is needed.
Unborn child	Congenital Malformations	Recent studies have found no increased risk of birth defects with dolutegravir compared to other ART options. Canadian data (over 2,000 pregnancies) found no neural tube defects linked to dolutegravir.
	Growth	Large studies show no major differences in low birth weight (less than 5 pounds 8 ounces [2500 grammes]) compared to other HIV treatments. More studies are needed to better understand if there’s a risk.
	Premature Birth	Large studies show no major differences in preterm birth compared to other HIV treatments. However, people living with HIV may have a higher risk of preterm birth overall. More studies are needed to better understand if there’s a risk.
	Stillbirth	Studies are reassuring and they do not show an increased risk compared to other HIV treatments. Rates are similar to the general population (about 0.6%).
Child later in life	Brain development	Only a few studies are available. So far, children exposed to dolutegravir during pregnancy show similar development to those not exposed to HIV or its treatment. More research is ongoing.
Fathers and sperm donors	Male’s fertility and pregnancy complications	No research has been done yet.

3. Asides from the risks, what are the benefits of dolutegravir?

For people living with HIV, taking effective treatment to control the virus is very important. A treatment plan that includes dolutegravir can be a safe and helpful option during pregnancy. Your healthcare provider can help you understand how these benefits apply to your situation.

Some possible benefits include:

Lower chance of passing HIV to your baby or partner: Dolutegravir helps lower the amount of HIV in your body (called viral load). When the viral load is low or undetectable, the risk of passing HIV during pregnancy and birth is less than 1%, compared to about 25% without treatment tooltip.
Helps protect your health during pregnancy: Keeping HIV well controlled supports your immune system and lowers the chance of serious health problems.
Easy to take: Dolutegravir is usually taken once a day and combined with other HIV medications (from NRTIs group) as part of treatment.
Generally well tolerated: Many people have few side effects, especially compared to some older HIV treatments. This can make it easier to stay on treatment.
No dose adjustment usually needed in pregnancy: Dolutegravir continues to work well throughout pregnancy and is recommended by research. Most people do not need to change their dose, unless advised by their healthcare provider.

Every pregnancy is different. Always talk to your healthcare provider about the benefits and risks based on your situation.

4. Can dolutegravir affect breastfeeding or milk supply (lactation)?

Research shows that dolutegravir passes into breast milk in low amounts. But we do not know exactly how this exposure can affect a baby over time.

Feeding decisions can feel emotional and personal. For people living with HIV, it’s important to have a discussion with your healthcare provider about feeding your baby. If breast/chest feeding is important to you, remaining on ART, like dolutegravir, can help minimise the risk of HIV transmission to the baby (less than 1%). In that context dolutegravir might be considered by your healthcare provider if the benefits of the treatment outweigh any theoretical risk.

If you have questions or worries, your healthcare team (midwife, nurse, doctor, nurse, pharmacist, lactation consultant) can help you the best option for your situation whether it is to feed your baby with human milk or with infant formula. Feeding support and resources are also available in your province or territory. All together, they can help you explore your options without judgment and support you in feeding your baby.

Key Takeaways

Dolutegravir (Tivicay®), use with another HIV medication (NRTIs), is a first-choice treatment to manage HIV for people who are pregnant or planning a pregnancy.
Recent studies show no higher risk of birth defects or pregnancy complications when dolutegravir is used during pregnancy.
Dolutegravir works quickly to lower the amount of HIV in the blood (viral load). This helps protect both the pregnant person and the baby by greatly reducing the risk of passing HIV during pregnancy and birth.
Dolutegravir is present in low concentrations in human milk. In Canada, breast/chest feeding is usually not recommended for people living with HIV. If you choose to breastfeed, dolutegravir can help reduce the risks of HIV transmission.
Always discuss with your healthcare team before starting, changing or stopping oxazepam during pregnancy or while breastfeeding.

6. Research is great, but it is not perfect

Making informed health decisions during pregnancy also means understanding what research can tell us and what it cannot tell yet. Research on HIV medications in pregnancy and lactation has helped us learn a lot, but it is still ongoing. There are some important reasons why research in this area has limits:

Not many large or long-term studies: There are fewer large studies that follow people over a long period of time, especially during pregnancy and after birth.
Limited information on long-term effects: We still do not fully know the long-term effects on a child’s development (such as learning or behaviour) or on the parent’s health. However, we do know that these medications have clear short-term benefits, including:
- reducing the chance of passing HIV to the baby
- improving the health of the pregnant and postpartum person
Pregnancy changes how the body works: During pregnancy, the body goes through many hormonal and physical changes. This can make it harder for researchers to know if a rare outcome is linked to a medication, the pregnancy itself, or other factors.

Because of these gaps, research is still needed. In the meantime, your healthcare provider can help you understand what this information means for your situation and support you in making the best decision for you and your baby.

A big thank you to Iris Vendittoli, Sameer Kassim, Sarah Khan, Sheliza Halani, Deborah Money, and Sean Sinden for their expertise on the revision of this factsheet.

Other resources

References

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