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The Potential Teratogenicity Alert for Women Conceiving on Dolutegravir-Based Regimens: An Assessment of Risk Communication by an Urban HIV Clinic in Uganda and Choices made by Women

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  • Eva Agnes Odongpiny Laker

    (Makerere University)

  • Arnold Arinaitwe

    (Makerere University)

  • Noela Owarwo

    (Makerere University)

  • Annet Onzia

    (Makerere University)

  • Benson Nasasira

    (Makerere University)

  • Abdullah Wailagala

    (Makerere University)

  • Ivan Kalule

    (Makerere University)

  • Godwin Anguzu

    (Makerere University)

  • Agnes Kiragga

    (Makerere University)

  • Kay Seden

    (University of Liverpool)

  • Isaac Lwanga

    (Makerere University)

  • Barbara Castelnuovo

    (Makerere University)

  • Rachel Musomba

    (Makerere University)

  • Mohammed Lamorde

    (Makerere University)

Abstract

Introduction and Objective In May 2018, the World Health Organization and other regulatory authorities released a safety alert for dolutegravir related to a risk of neural tube defects among women exposed to dolutegravir at the time of conception. Models of how drug safety information can be shared effectively in the shortest time are necessary to prevent interruptions of public health programs. We sought to describe an implementation process to inform and support women already on dolutegravir-based regimens at the time of conception to make informed choices following the safety alert of a potential teratogenicity risk. We describe the choices made by women, as well as determine the factors associated with women’s choices to switch off dolutegravir. Methods A clinic response plan was developed in the first week following the alert and clinic staff were trained on safety guidance. All women aged

Suggested Citation

  • Eva Agnes Odongpiny Laker & Arnold Arinaitwe & Noela Owarwo & Annet Onzia & Benson Nasasira & Abdullah Wailagala & Ivan Kalule & Godwin Anguzu & Agnes Kiragga & Kay Seden & Isaac Lwanga & Barbara Cast, 2020. "The Potential Teratogenicity Alert for Women Conceiving on Dolutegravir-Based Regimens: An Assessment of Risk Communication by an Urban HIV Clinic in Uganda and Choices made by Women," Drug Safety, Springer, vol. 43(11), pages 1133-1140, November.
    • Handle: RePEc:spr:drugsa:v:43:y:2020:i:11:d:10.1007_s40264-020-00974-9
    DOI: 10.1007/s40264-020-00974-9
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