• Potential safety issue in using dolutegravir at time of conception Team PATA

Potential safety issue in using dolutegravir at time of conception

You may be aware that on 18 May 2018 the World Health Organisation (WHO) issued a statement on potential safety issues affecting women living with HIV using dolutegravir (DTG) at the time of conception. Since then WHO headquarters, regional and country offices have been actively working with countries and partners to explore policy and implementation implications and actions to help ensure that any potential risk is appropriately considered and managed while also ensuring minimum impact on national treatment programmes.

In summary, the current WHO guidance is;

  • Pregnant women who are taking DTG should not stop their antiretroviral therapy (ART).
  • ART for women of childbearing age, including pregnant women, should be based on drugs with adequate efficacy and safety data.  Efavirenz (EFV)-based regimens are safe and effective first-line regimens.
  • If other first-line ARVs cannot be used in women of childbearing age, DTG may be considered if consistent contraception can be assured.
  • Programs should continue to strengthen pharmacovigilance, including monitoring of birth outcomes

During this period of uncertainty and until such time that there are data from larger numbers of exposures to determine the level of risk it is strongly advised to follow your countries national guidance on how DTG should be used in women of childbearing age at this present time.

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