On May 18th2018 the World Health Organization (WHO) issued a statement following the identification of a potential safety issue with Dolutegravir (DTG) related to neural tube defects such as lack of full development of the brain and spine in infants born to women who were taking DTG at the time of conception. DTG is also sold under the brand name Tivicay.
According to the WHO statement  the safety issue was identified from a preliminary unscheduled analysis of an ongoing observational study in Botswana, Africa which found four cases of neural tube defected out of 426 women who became pregnant while taking DTG.
The WHO statement indicates that “the potential safety issue arises from a woman’s exposure to DTG at the time of conception, rather than during pregnancy.” ICW has learned that the same study has yielded no evidence of neural tube defects among infants born to women who initiated DTG-based regimens during pregnancy. It is important to note that data and information is very limited at this time.
The study in Botswana is ongoing, and results from additional pregnant women who were using DTG-based regimens at the time of conception are expected over the next 9 to 12 months.
Since Dolutegravir was approved by the US FDA in 2013, it has become popular for many as it is more easily tolerated, costs less, can lead to faster viral suppression and is less susceptible to resistance.
ICW continues to be in contact with the HIV department at WHO and would like to inform our members that we are keenly monitoring developments and working closely with WHO and various regional and global HIV treatment and prevention stakeholders to understand what this news means for women living with HIV, particularly those of reproductive age who are planning to or may become pregnant and are already taking DTG or interested in accessing DTG.
We urge our members to act on the advice by WHO and other key partners globally and at country level by doing the following; -
- Women and girls who are currently taking Dolutegravir should not stop taking their medicine without first consulting their doctor or a health care provider.
- Women and girls who are taking dolutegravir and can become pregnant should use an effective contraception.
- Women who are taking Dolutegravir and wish to become pregnant should talk to their doctor or health care provider about whether Dolutegravir remains the most appropriate treatment.
- Women who are pregnant and using Dolutegravir, should consult their doctor or health care provider immediately.
- Do not discontinue dolutegravir without consulting your doctor to understand how to ensure continuity of your own life-saving treatment and prevent vertical transmission of HIV from mother to child.
- Women who are currently taking dolutegravir MUST inform their doctor if they become pregnant, think they might be pregnant or are planning to become pregnant. Your doctor or health provider will review your treatment.
- If you have any questions about your treatment or contraception, speak to your doctor or health provider before making any decisions.
PLEASE NOTE THAT THIS ADVICE MAY CHANGE AS MORE INFORMATION BECOMES AVAILABLE.
ICW commits to keeping you updated on any new developments as they arise. For more information, we encourage our members to read the WHO fact sheet link here.
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