Viread

THE SAFETY OF TENOVIR (VIREAD) DURING PREGNANCY OR BREASTFEEDING

The information provided below is for readers based in the United States of America. Readers outside of the United States of America should seek the information from local sources.

This medication is considered to have a low risk when used during pregnancy:

Although human data are limited, tenovir is not associated with birth defects and can prevent viral transmission of HIV or Hepatitis B to the developing baby. Tenovir should only be used pregnant women who have clear indications for antiretroviral therapy. Breastfeeding is generally not recommended in HIV positive women.

What is tenovir?

Tenovir is an antiretroviral medication used to treat human immunodeficiency virus (HIV) and hepatitis B. The medication is often used in combination with other antiretroviral medications for HIV treatment.

What is tenovir used to treat?

Tenovir is a prescription medication used to treat HIV types I and II and Hepatitis B infections in adults and children.

How does tenovir work?

Tenovir is a type of antiretroviral medication known as a nucleotide reverse transcriptase inhibitor (NRTI). Tenovir inhibits replication of the HIV and Hepatitis B viruses.

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

Animal studies have not found an increased risk of birth defects, although decreased growth in the baby is a possible risk with use during pregnancy. Some evidence suggests tenovir may increase the risk of preterm delivery. If the medication is needed by the mother, it should not be withheld due to pregnancy. The benefit of tenovir to the mother is expected to outweigh any negative effects to the developing baby. Tenovir is expected to cross the human placenta to reach the baby. The Antiretroviral Pregnancy Registry analysed data on pregnant women on antiretroviral therapy who gave birth between 1989 and 2009, finding no increased risk of birth defects. Animal and human studies have found that infants exposed to tenovir while in utero are more likely to have a smaller head size and smaller body length. Tenvoir is one of the antiretroviral medications that is preferred for use during pregnancy.

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

HIV positive women who want to conceive should discuss with their doctor before conceiving. 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 is 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 baby. Tenovir therapy in pregnant women with Hepatitis B may prevent viral transmission to the baby. 

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

Tenovir is expected to pass into human breast milk, with infants being exposed to an estimated 0.03% of a mother’s dose of tenovir. 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 woman even with antiretroviral therapy for prevention. Women who are on tenovir therapy to treat Hepatitis B may continue to breastfeed their infants; however, it is important to discuss with your doctor. The manufacturer of tenovir recommends not breastfeeding while on this medication.

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

Animal studies have found that high doses of tenovir do not negatively affect fertility. One study in a small group of men exposed to tenovir therapy found that sperm quality was unaffected, but sperm movement was impaired.

If I am taking tenovir, what should I know?

Tenovir antiretroviral therapy is generally recommended in pregnant women with HIV or Hepatitis B to prevent viral transmission to the developing baby.There is limited information on use of tenovir during pregnancy, but available studies have not identified an increased risk of birth defects. Breastfeeding may be continued in women on tenovir to treat Hepatitis B, but HIV positive women on tenovir 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 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 tenovir during and after pregnancy, contact http://www.womenshealth.gov/ (800-994-9662 [TDD: 888-220-5446]) or check the following link:

Gilead: Viread Prescribing Information

Read the whole report
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.