Important safety update on dolutegravir (TIVICAY/ TRIUMEQ): Neural tube defects reported in Tsepamo Study, Botswana

GlaxoSmithKline Pte Ltd, on behalf of ViiV Healthcare, would like to inform healthcare professionals of a potential safety issue of neural tube defect (NTD) in infants born to women exposed to dolutegravir-containing regimens at the time of conception. This safety concern was identified from a preliminary analysis of the Tsepamo study where 4 NTD cases out of 426 pregnancies on dolutegravir were observed, representing an incidence of 0.9% compared with an expected background rate of 0.1%. This study is ongoing and further data will be captured during the ongoing surveillance. While this safety signal is being evaluated, ViiV Healthcare recommends that pregnancy testing be performed before initiation of treatment in women of child bearing potential (WOCBP). WOCBP who are taking dolutegravir should avoid getting pregnant and to use effective contraception throughout treatment. In WOCBP who are actively seeking to become pregnant, it is recommended to avoid dolutegravir, unless a suitable alternative treatment is not available. If a woman becomes pregnant while taking dolutegravir, it is recommended to switch to an alternative regimen. GlaxoSmithKline Pte Ltd is working with HSA to update the package insert and further information will be communicated as appropriate. Please refer to the letter for details.  Published: 30 May 2018

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