Support for ending and managing HIV

Australian Government Department of Health, 29 November 2018

The Australian Government is strengthening its commitment to ending HIV with the announcement of funding for a new strategy that aims to virtually eliminate the transmission of HIV, the approval of the first HIV self-testing kit and the listing of a new medicine on the PBS.

The first HIV self-testing kit, the Atomo Self Test was approved for use by the TGA yesterday. The test is a single-use rapid finger stick test for the detection of antibodies to HIV and will enable people to test for HIV in their own home.

This will make testing accessible and convenient especially for people that need to test frequently or do not test at all.

The medicine Juluca® (dolutegravir and rilpivirine), which works to stop the replication of the HIV virus, will be listed on the PBS on December 1, which is World AIDS Day.

 

New study suggests risk of birth defects in babies born to women on HIV medicine dolutegravir

European Medicines Agency, 18/05/2018

The European Medicines Agency (EMA) is evaluating preliminary results from a study which found 4 cases of birth defects such as spina bifida (malformed spinal cord) in babies born to mothers who became pregnant while taking dolutegravir. While EMA is assessing the new evidence it has issued the following precautionary advice:

  • Dolutegravir HIV medicines should not be prescribed to women seeking to become pregnant.
  • Women who can become pregnant should use effective contraception while taking dolutegravir medicines.

The study, which looked at babies born to 11,558 HIV-infected women in Botswana, showed that 0.9% of babies (4 of 426) whose mothers became pregnant while taking dolutegravir had a neural tube defect, compared with 0.1% of babies (14 of 11,173) whose mothers took other HIV medicines. Final results are expected in about a year.

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

EMA will update the recommendations as necessary when it concludes its assessment.