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

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 Castelnuovo, Rachel Musomba and Mohammed Lamorde
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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

Drug Safety, 2020, vol. 43, issue 11, No 6, 1133-1140

Abstract: 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

Date: 2020
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DOI: 10.1007/s40264-020-00974-9

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