THIS MEDICATION CAN CAUSE HARM TO YOUR BABY:
Although human data is limited, efavirenz is associated with birth defects from first trimester exposure. Efavirenz/emtricitabine/tenofovir can prevent viral transmission of HIV to the developing baby, but this medication should only be used in pregnant women who have clear indications for antiretroviral therapy. Breastfeeding is not recommended in HIV positive women.
What is efavirenz/emtricitabine/tenofovir?
Efavirenz/emtricitabine/tenofovir combination is an antiretroviral medication used to treat human immunodeficiency virus type I (HIV-1).
What is efavirenz/emtricitabine/tenofovir used to treat?
Efavirenz/emtricitabine/tenofovir combination is a prescription medication used to treat HIV-1 in adults and children aged 12 years or older. This medication is an initial treatment option in pregnant women who have never taken antiretroviral therapy. It is used as a complete regimen to treat HIV-1 or can be used in combination with other antiretroviral medications.
How does efavirenz/emtricitabine/tenofovir work?
Efavirenz/emtricitabine/tenofovir combination is a type of antiretroviral medication that is a three-drug combination of a non-nucleoside analog reverse transcriptase inhibitor (efavirenz) and two nucleoside analog reverse transcriptase inhibitors or NRTIs (tenovir and emtricitabine) that inhibit replication of the HIV virus. In other words, these three medicines combine to keep the HIV virus from multiplying in your body.
If I am taking efavirenz/emtricitabine/tenofovir, can it harm my baby?
First trimester exposure to efavirenz has been associated with birth defects and low birth weight. The Antiretroviral Pregnancy Registry analysed data on pregnant women using antiretroviral therapy who gave birth between 1989 and 2009, finding no increased risk of birth defects except with efavirenz. If the medication is indicated in the mother, it should not be withheld due to pregnancy. Compared to other antiretroviral therapies, efavirenz/emtricitabine/tenofovir is associated with better birth outcomes when used during pregnancy.
If I am taking efavirenz/emtricitabine/tenofovir and become pregnant, what should I do?
HIV positive women who want to conceive should talk to their doctor before becoming pregnant. It is important to be in good health and on antiretroviral therapy that has decreased your viral load before pregnancy. Pregnancy testing is recommended prior to starting this medication, with contraception recommended in reproductive age women during therapy and 12 weeks after discontinuing therapy with this medication. 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 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 with three different medications to prevent transmission to the developing baby.
If I am taking efavirenz/emtricitabine/tenofovir, can I safely breastfeed my baby?
Efavirenz, tenovir, and emtricitabine are expected to pass into human breast milk. 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 recommends not breastfeeding if you are an HIV positive women on antiretroviral therapy.
If I am taking efavirenz/emtricitabine/tenofovir, will it be more difficult to get pregnant?
Efavirenz/emtricitabine/tenofovir has been linked to decreased sperm movement in men exposed to this medication. In women, this combination medication can interfere with contraceptive concentrations in the body.
If I am taking efavirenz/emtricitabine/tenofovir, what should I know?
Efavirenz/emtricitabine/tenofovir combination antiretroviral therapy is recommended in pregnant women with HIV to prevent viral transmission to the developing baby. There is limited information on the use of efavirenz/emtricitabine/tenofovir combination during pregnancy, but available studies link efavirenz to an increased risk of birth defects. HIV positive women on efavirenz/emtricitabine/tenofovir combination therapy should not breastfeed.
If I am taking any medication, what should I know?
This report provides a summary of available information about the use of NRTIs/non-NRTIs during pregnancy and breastfeeding. Content is from the product label unless otherwise indicated.
You may find Pregistry's expert report about HIV here. Additional information can also be found in the resources below.
For more information about efavirenz/emtricitabine/tenofovir during and after pregnancy, contact http://www.womenshealth.gov/ (800-994-9662 [TDD: 888-220-5446]) or check the following link:
Gilead: Atripla Prescribing Information
General information
It is very common for women to worry about having a miscarriage or giving birth to a child with a birth defect while they are pregnant. Many decisions that women make about their health during pregnancy are made with these concerns in mind.
For many women these concerns are very real. As many as 1 in 5 pregnancies end in a miscarriage, and 1 in 33 babies are born with a birth defect. These rates are considered the background population risk, which means they do not take into consideration anything about the health of the mom, the medications she is taking, or the family history of the mom or the baby’s dad. A number of different things can increase these risks, including taking certain medications during pregnancy.
It is known that most medications, including over-the-counter medications, taken during pregnancy do get passed on to the baby. Fortunately, most medicines are not harmful to the baby and can be safely taken during pregnancy. But there are some that are known to be harmful to a baby’s normal development and growth, especially when they are taken during certain times of the pregnancy. Because of this, it is important to talk with your doctor or midwife about any medications you are taking, ideally before you even try to get pregnant.
If a doctor other than the one caring for your pregnancy recommends that you start a new medicine while you are pregnant, it is important that you let them know you are pregnant.
If you do need to take a new medication while pregnant, it is important to discuss the possible risks the medicine may pose on your pregnancy with your doctor or midwife. They can help you understand the benefits and the risks of taking the medicine.
Ultimately, the decision to start, stop, or change medications during pregnancy is up to you to make, along with input from your doctor or midwife. If you do take medications during pregnancy, be sure to keep track of all the medications you are taking.