July 2018

EGPAF Statement on Guidance Regarding Use of Dolutegravir by Pregnant Women

Media Contact: Meghan Quinn (mquinn@pedaids.org); Eliza Dryer (edryer@pedaids.org)

July 23, 2018 – Amsterdam, Netherlands – The Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) welcomes the World Health Organization’s (WHO) guidance released earlier today on the use of dolutegravir (DTG) ​in women of childbearing age.

DTG is a preferred regimen for many women, with demonstrated efficacy, tolerability, and a high genetic barrier to drug resistance.  Recent data from a NIH-funded birth outcome surveillance observational study in Botswana has raised questions around safety for infants born to women taking HIV antiretroviral DTG therapy at the time of conception​.

In its guidance today, WHO notes that the Botswana data identified a signal of a potential safety risk with exposure to DTG at the time of conception. This data found a potential small, but increased risk of neural tube defects among infants (a rate of 0.94%). WHO has recommend that DTG may be considered a preferred first- or second-line drug for “everyone living with HIV over six years and weighing more than 15 kg, including adolescents and young women of childbearing potential, who are using consistent and reliable contraception.”  Additional data from women who have already become pregnant while receiving DTG but have not yet delivered will be available from the Botswana study and other studies in the next 9 to 12 months to confirm or refute this potential safety signal.  EGPAF will continue to closely monitor the data as it becomes available, and will contribute to technical review to optimally inform our care and treatment services.

WHO notes that women who are taking DTG and are currently pregnant should not stop their antiretroviral treatment, as exposure has already occurred; rather, they should speak with their health care provider for additional guidance.  For women who are already pregnant, stopping a DTG-containing regimen without switching to alternative HIV medicines could cause the amount of virus in the body to increase, spreading HIV to the baby and negatively impacting the mother’s health.

As a leading global organization providing HIV prevention, care, and treatment services to HIV positive pregnant women, EGPAF takes these data seriously, while also supporting a full analysis of all the related risks and benefits to women and infants, and taking into account the voices of those who want (and should have) access to the best possible treatment regimens.  EGPAF continues to support access to voluntary family planning services for women and adolescents of reproductive age living with HIV, in this case to ensure maximal access to DTG while also reducing potential risks.