[Comment] Dolutegravir: advancing ethical research in pregnancy
General News

[Comment] Dolutegravir: advancing ethical research in pregnancy

On July 22, 2019, members of the HIV community seemed to breathe a collective sigh
of relief when WHO recommended dolutegravir, a new antiretroviral medication, as the
preferred first-line and second-line HIV treatment for all populations.



WHO

WHO recommends dolutegravir as preferred HIV treatment option in all populations.

The announcement followed more than a year of uncertainty and debate about the appropriateness
of using the drug in women who are pregnant or of childbearing potential after preliminary
data from a large surveillance study in Botswana showed a potential safety signal
for dolutegravir and an increased risk of neural tube defects in periconceptually
exposed infants.



  • Zash R
  • Makhema J
  • Shapiro R

Neural-tube defects with dolutegravir treatment from the time of conception.

On the basis of the preliminary findings of this interim analysis, regulatory agencies
cautioned against use of dolutegravir in women planning or at risk of pregnancy



European Medicines Agency

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



US Food and Drug Administration

FDA drug safety communication: FDA to evaluate potential risk of neural tube birth
defects with HIV medication dolutegravir.

and many jurisdictions restricted use of the drug by women who were pregnant or of
childbearing age.



  • Nakkazi E

Changes to dolutegravir policy in several African countries.

This article is available free of charge.

Simply log in to access the full article, or register for free if you do not yet have a username and password.

References

  1. 1.
    • WHO

    WHO recommends dolutegravir as preferred HIV treatment option in all populations.

  2. 2.
    • Zash R
    • Makhema J
    • Shapiro R

    Neural-tube defects with dolutegravir treatment from the time of conception.

    N Engl J Med. 2018; 379: 979-981

  3. 3.
    • European Medicines Agency

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

  4. 4.
    • US Food and Drug Administration

    FDA drug safety communication: FDA to evaluate potential risk of neural tube birth defects with HIV medication dolutegravir.

  5. 5.
    • Nakkazi E

    Changes to dolutegravir policy in several African countries.

    Lancet. 2018; 392: 199

  6. 6.
    • Zash R
    • Holmes L
    • Diseko M
    • et al.

    Neural-tube defects and antiretroviral treatment regimens in Botswana.

    N Engl J Med. 2019; 381: 827-840

  7. 7.
    • Phillips AN
    • Venter F
    • Havlir D

    Risks and benefits of dolutegravir-based antiretroviral drug regimens in sub-Saharan Africa: a modelling study.

    Lancet HIV. 2018; 6: 116-127

  8. 8.
    • Mofenson LM
    • Pozniak AL
    • Wambui J
    • et al.

    Optimizing responses to drug safety signals in pregnancy: the example of dolutegravir and birth defects.

    JIAS. 2019; 22e25352

  9. 9.
    • Krubiner C
    • Faden RR
    • Cadigan RJ
    • et al.

    Advancing HIV research with pregnant women: navigating challenges and opportunities.

    AIDS. 2016; 30: 2251-2255

  10. 10.
    • Little M
    • Wikremsinhe M

    Research with pregnant women: a call to action.

    Reprod Health. 2017; 14: 156

  11. 11.
    • Lyerly AD
    • Little M
    • Faden RR

    The second wave: toward responsible inclusion of pregnant women in research.

    Int J Feminist Approaches to Bioeth. 2008; 1: 5-22

  12. 12.
    • Lyerly AD
    • Mitchell LM
    • Mitchell Armstrong E
    • et al.

    Risk and the pregnant body.

    Hastings Cent Rep. 2009; 39: 34-42

  13. 13.

    Communique of the Kigali Dolutegravir Stakeholder Meeting of African Women Living with HIV, hosted by AfroCAB.

Article Info

Publication History

Published: 30 November 2019

Identification

DOI: https://doi.org/10.1016/S0140-6736(19)32638-8

Copyright

© 2019 Elsevier Ltd. All rights reserved.

ScienceDirect

Access this article on ScienceDirect

Related posts

PLANS TO FREEZE KHAMA’S ACCOUNTS REVEALED – Roseline Panzirah Matsome

BWNews

Prince Harry’s Sweet Welcome Message at Botswana Charity Was Just Revealed

BWNews

The story behind Botswana closest-ever election and how its consequences will play out

BWNews

Leave a Reply