Southern African HIV Clinicians Society Guidance on the use of dolutegravir in first-line antiretroviral therapy.

Abstract

In preliminary data from the Tsepamo study in Botswana, it was found that 0.94% (95% confidence interval [CI]: 0.37 – 2.4) of babies (4/426) born to women who were taking dolutegravir periconception had neural tube defects (NTDs), compared with 0.1% of babies (14/11 173) of women taking other antiretroviral drugs (ARVs) in the periconception period.1 No NTDs were observed in pregnancies where dolutegravir was initiated later in pregnancy. Further data from the Tsepamo study were presented at AIDS 2018: the updated number of NTDs with periconception dolutegravir exposure in the Tsepamo cohort is 4/596, 0.67% (95% CI: 0.26 to 1.7). The next formal analysis will occur after 31 March 2019 and will include women exposed to dolutegravir from conception before the recent change in guidance. Tsepamo plans to expand the number of study sites, increasing the coverage from 45% to 72% of births in Botswana with a projected denominator of over 1200 by March 2019.1