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Safety advisory - new study suggests possible risk of birth defects

31 May 2018

The TGA is closely monitoring the safety of dolutegravir after preliminary results from a new study suggested risk of birth defects in babies born to women being treated with this medicine. In the meantime, dolutegravir should not be used in women seeking to become pregnant.

Dolutegravir is used to treat human immunodeficiency virus (HIV) infection in adults and in children over 12. It is marketed in Australia under the brand name Tivicay and is one of three active ingredients in Triumeq.

Dolutegravir does not cure HIV infection or acquired immune deficiency syndrome (AIDS), but it may hold off damage to the immune system and the development of infections and diseases associated with AIDS.

The preliminary results of the Tsepamo Study, conducted in Botswana, identified a potential risk of neural tube defects in babies born to women with exposure to dolutegravir-containing regimens at the time of conception.

The Tsepamo study, which looked at babies born to 11,558 HIV-infected women, showed that 0.9% of babies (4 of 426) whose mothers became pregnant while taking dolutegravir had a neural tube defect, such as spina bifida. This compared with 0.1% of babies (14 of 11,173) whose mothers took other HIV medicines.

No cases were reported in infants born to women who started dolutegravir later during pregnancy.

Final results from the study are expected in about a year.

While this issue is being investigated, dolutegravir should not be used in women seeking to become pregnant and women who can become pregnant should use effective contraception while taking it.

Women who have been prescribed dolutegravir should not stop taking their medicine without first consulting their doctor.

Information for consumers

If you are a woman taking dolutegravir, please be aware of this issue.

If you can become pregnant, you should use effective contraception while taking dolutegravir.

If you wish to become pregnant, talk to your doctor about reviewing your treatment.

If you are pregnant and using dolutegravir, consult your doctor. Do not discontinue dolutegravir without consulting your doctor, as this may harm you and your unborn child.

Tell your doctor if you become pregnant, think you might be pregnant or are planning to become pregnant, so that they can review your treatment.

If you have any questions or concerns about this issue, talk to your health professional.

Information for health professionals

The sponsor of dolutegravir, ViiV Healthcare, has written to health professionals to provide further information about this issue.

Please note that, dolutegravir was tested in a complete package of reproductive toxicology studies, including embryofetal development studies, and no relevant findings were identified. Likewise, while there is limited experience with the use of dolutegravir in pregnancy, other data analysed to date from all sources, including Antiretroviral Pregnancy Registry, clinical trials and post-market use, has not indicated a risk of neural tube defects.

If you are treating a female patient who is taking dolutegravir, discuss this issue with them at their next appointment.

As a precaution:

  • do not prescribe dolutegravir for women of child-bearing potential who are trying to become pregnant
  • exclude pregnancy in women of child-bearing potential before starting dolutegravir
  • advise women of child-bearing potential who are taking dolutegravir to use effective contraception during treatment
  • if pregnancy is confirmed in the first trimester while a woman is taking dolutegravir, switch to an alternative treatment unless there is no suitable alternative.

The TGA will be working with ViiV Healthcare to update Product Information accordingly and further information will be communicated as appropriate.

If you have any questions or concerns about this issue, contact ViiV Healthcare on 1800 499 226.

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.