FAQs for women of childbearing potential and dolutegravir: Key interim considerations

A forum on the risks of preconception dolutegravir exposure has pulled together frequently asked questions (FAQs) designed to help provide context and to support public health and clinical decision-making bodies as they balance the current potential concerns about the use of DTG in women of childbearing potential against its known benefits.

Download FAQs for Dolutegravir & Women of Childbearing Potential: Interim Considerations (PDF) here.

The FAQs include:

  • What are the advantages of a DTG-based ART regimen over an efavirenz (EFV)-based ART regimen?
  • What are the data about periconceptional use of DTG and neural tube defects that led to the caution about its use in women of childbearing potential?
  • What additional data are being collected and when will an answer about the potential risk of NTDs with periconceptional use of DTG be available?
  • What are the contraceptive options that should be offered to women of child-bearing potential, including those who want to take DTG regimens?
  • What is the bottom line?

About the forum

Over the past few years, through the efforts of multiple stakeholders and government leadership, antiretroviral regimens containing dolutegravir (DTG) have become accessible to the vast majority of persons living with HIV (PLHIV) throughout the world. Plans to transition most PLHIV to DTG-containing regimens has brought with them the promise of a more efficacious, safe and durable regimen for individuals as well as the achievement of epidemic control through community levels of viral suppression.

In response to data from the Tsepamo birth defect surveillance study in Botswana, suggesting that periconceptional use of DTG may be associated with a small (under 1%) but significantly increased risk of neural tube defects (NTDs) in infants compared to the risk in women receiving non-DTG regimens or among HIV-negative women, HIV treatment guidelines groups from around the world have made recommendations on the potential safety risks of preconception DTG exposure. This advice is dependent on further data becoming available.  Unless these data are collected swiftly, comprehensively, and in an epidemiologically robust manner the decision to roll out DTG-based antiretroviral therapy (ART) or not on a global basis could be delayed and/or limited.

Using this as an example, the IAS convened a high-level group of experts to gather and discuss data quality, data interpretation and appropriate messaging of the risks and benefits of administering ART such as DTG to HIV-infected women of child-bearing age.  This effort should be considered complimentary to other efforts presently being undertaken by the WHO Advisory Committee on the Safety of Medical Products, the WHO guidelines processes, other regulatory agencies, and drug manufacturers. It will be an academic exercise whose outputs and process might be applied to any drug used in pregnancy and inform regulators responsible for pharmacovigilance.

Forum participants include representatives from IAS, CDC, ITPC, AfroCAB, iBase, WHO, Gates Foundation, EGPAF, Botswana Ministry of Health, UCL, Georgetown University, PENTA, and others.

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